BS

BSEN
EN60601-2-27:2014
60601-2-27:2014

BSI Standards Publication

Medical electrical equipment

Part 2-27: Particular requirements for the
basic safety and essential performance of
electrocardiographic monitoring equipment
BS EN 60601-2-27:2014 BRITISH STANDARD

National foreword
This British Standard is the UK implementation of EN 60601-2-27:2014.
It is identical to IEC 60601-2-27:2011, incorporating corrigendum 2012.
It supersedes BS EN 60601-2-27:2006, which will be withdrawn on
22 August 2017.
IEC corrigendum May 2012 inserts Annex ZA and Annex ZZ.
The start and finish of text introduced or altered by corrigendum is
indicated in the text by tags. Text altered by IEC corrigendum May 2012
is indicated in the text by .
The UK participation in its preparation was entrusted by Technical
Committee CH/62, Electrical Equipment in Medical Practice, to
Subcommittee CH/62/4, Electromedical equipment.
A list of organizations represented on this subcommittee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.
© The British Standards Institution 2014.
Published by BSI Standards Limited 2014
ISBN 978 0 59724 4
ICS 11.040.50
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the Standards
Policy and Strategy Committee on 30 September 2014.
Amendments/corrigenda issued since publication
Date Text affected
 BS EN 60601-2-27:2014

EUROPEAN STANDARD EN 60601-2-27

NORME EUROPÉENNE
EUROPÄISCHE NORM August 2014

ICS 11.040.50 Incorporating

Supersedescorrigendum May 2012
EN 60601-2-27:2006

English Version

Medical electrical equipment - Part 2-27: Particular requirements

for the basic safety and essential performance of
electrocardiographic monitoring equipment
(IEC 60601-2-27:2011 + corrigendum May 2012)

Appareils électromédicaux - Partie 2-27: Exigences Medizinische elektrische Geräte - Teil 2-27: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles
essentielles des appareils
des dede
appareils surveillance
surveillance wesentlichen Leistungsmerkmale von Elektrokardiographie-
d'électrocardiographie
d’électrocardiographie Überwachungsgeräten
(CEI 60601-2-27:2011 + corrigendum Mai 2012) (IEC 60601-2-27:2011 + Berichtigung Mai 2012)

This European Standard was approved by CENELEC on 2011-05-04. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization

Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-27:2014 E

BS EN 60601-2-27:2014
EN 60601-2-27:2014 -2-

Foreword
The text of document 62D/900/FDIS, future edition 3 of IEC 60601-2-27, prepared by SC 62D,
"Electromedical equipment", of IEC TC 62, "Electrical equipment in medical practice", was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-27:2014.

The following dates are fixed:

• latest date by which the document has (dop) 2015-02-22

to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-08-22
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-27:2006.

In this standard, the following print types are used:

– Requirements and definitions: roman type.

– Test specifications: italic type.

– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.

In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;

– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
 BS EN 60601-2-27:2014
-3- EN 60601-2-27:2014

– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.

Endorsement notice
The text of the International Standard IEC 60601-2-27:2011+ corrigendum May 2012 was approved by
CENELEC as a European Standard without any modification.
BS EN 60601-2-27:2014
EN 60601-2-27:2014 -4-

Annex ZA
(normative)

Normative references to international publications

with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Annex ZA of the general standard applies, except as follows:

Publication Year Title EN/HD Year

Replacement:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007

(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
Addition:
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for basic + A11 2011
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories
1
IEC 60601-2-25 2011 Medical electrical equipment - EN 60601-2-25 201X
Part 2-25: Particular requirements for basic
safety and essential performance of
electrocardiographs
1)
IEC 60601-2-49 2011 Medical electrical equipment - EN 60601-2-49 201X
Part 2-49: Particular requirements for the
basic safety and essential performance of
multifunction patient monitoring equipment

1
At draft stage.
 BS EN 60601-2-27:2014
-5- EN 60601-2-27:2014

Annex ZZ
(informative)

Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows:

– Essential Requirement 6a
– Essential Requirement 7.4
– Essential Requirement 7.5 paragraph 2 & 3
– Essential Requirement 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.

WARNING - Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
 BS EN 60601-2-27:2014
–2– 60601-2-27  IEC:2011

CONTENTS
INTRODUCTION ..................................................................................................................... 6
201.1 Scope, object and related standards ......................................................................... 7
201.2 Normative references ................................................................................................ 8
201.3 Terms and definitions ................................................................................................ 9
201.4 General requirements .............................................................................................. 10
201.5 General requirements for testing of ME EQUIPMENT ................................................... 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 12
201.7 M E EQUIPMENT identification, marking and documents.............................................. 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................ 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .............. 22
201.10 Protection against unwanted and excessive radiation HAZARDS ................................ 22
201.11 Protection against excessive temperatures and other HAZARDS ................................ 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .................................................................................................................... 24
201.13 H AZARDOUS SITUATIONS and fault conditions ............................................................. 41
201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................... 41
201.15 Construction of ME EQUIPMENT ................................................................................. 41
201.16 M E SYSTEMS ............................................................................................................ 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................. 42
202 Electromagnetic compatibility – Requirements and tests ......................................... 42
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems ................................................ 47
Annexes ............................................................................................................................... 53
Annex AA (informative) Particular guidance and rationale .................................................... 54
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 ........................ 65
Bibliography .......................................................................................................................... 68
Index of defined terms used in this particular standard.......................................................... 69

Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveforms

for testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6). .............. 16
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) ................................................................................................................................... 20
Figure 201.103 – Test of protection against the effects of defibrillation (common mode) ....... 21
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator .................................................................................................. 22
Figure 201.105 – General test circuit .................................................................................... 26
Figure 201.106 – High frequency response ........................................................................... 31
Figure 201.107 – Test circuit for COMMON MODE REJECTION .................................................... 33
Figure 201.108 – Baseline reset ........................................................................................... 34
Figure 201.109 – Pacemaker pulse ....................................................................................... 35
Figure 201.110 – Test waveforms for T-wave rejection ......................................................... 37
Figure 201.111 – Normal paced rhythm ................................................................................ 37
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 –3–

Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at

80 1/min) .............................................................................................................................. 38
Figure 201.113 – Simulated QRS complex ............................................................................ 38
Figure 201.114 – Pacemaker test circuit ............................................................................... 38
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
immunity test ........................................................................................................................ 43
Figure 202.102 – Set-up for radiated IMMUNITY test ............................................................... 44
Figure 202.103 – Test circuit for HF surgery protection measurement ................................... 46
Figure 202.104 – Test setup for HF surgery protection measurement.................................... 47
Figure AA.1 – A PPLIED PART with multiple PATIENT CONNECTIONS ............................................ 56
Figure BB.101 – N ON - LATCHING ALARM SIGNALS without ALARM RESET ..................................... 65
Figure BB.102 – N ON - LATCHING ALARM SIGNALS with ALARM RESET .......................................... 65
Figure BB.103 – L ATCHING ALARM SIGNALS with ALARM RESET ................................................. 66
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET .................................................... 66

Table 201.101 – E SSENTIAL PERFORMANCE requirements ....................................................... 11

Table 201.102 – E LECTRODES and NEUTRAL ELECTRODE , their position, identification and
colour ................................................................................................................................... 13
Table 201.103 – Protection against the effect of defibrillation (test conditions) ...................... 19
Table 208.101 – A LARM CONDITION priorities .......................................................................... 48
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS ............................... 49
Table AA.1 – Electrode positions and electrical strength requirements .................................. 55
 BS EN 60601-2-27:2014
–6– 60601-2-27  IEC:2011

INTRODUCTION

This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT . It amends and supplements IEC 60601-1
(third edition, 2005): Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance hereinafter referred to as the general standard.

The aim of this third edition is to bring this particular standard up to date with reference to the
third edition of the general standard through reformatting and technical changes.

The requirements of this particular standard take priority over those of the general standard.

A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that knowledge of the reasons for these
requirements will not only facilitate the proper application of the standard but will, in due
course, expedite any revision necessitated by changes in clinical practice or as a result of
developments in technology. However, Annex AA does not form part of the requirements of
this standard.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 –7–

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment

201.1 Scope, object and related standards

Clause 1 of the general standard 1) applies, except as follows:

201.1.1 *Scope

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of

ELECTROCARDIOGRAPHIC ( ECG ) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter
also referred to as ME EQUIPMENT . This particular standard applies to ME EQUIPMENT used in a
hospital environment as well as when used outside the hospital environment, such as in
ambulances and air transport. This particular standard also applies to ECG telemetry systems
used in a hospital environment.

M E EQUIPMENT intended for use under extreme or uncontrolled environmental conditions

outside the hospital environment, such as in ambulances and air transport, shall comply with
this particular standard. Additional standards may apply to ME EQUIPMENT for those
environments of use.

This standard is not applicable to electrocardiographic monitors for home use. However,
MANUFACTURERS should consider using relevant clauses of this standard as appropriate for
their INTENDED USE .

Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices,
and other ECG recording equipment are outside the scope of this particular standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for ELECTROCARDIOGRAPHIC ( ECG ) MONITORING EQUIPMENT as defined in 201.3.63.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208
respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the
IEC 60601-1 series apply as published.

—————————
1) The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
 BS EN 60601-2-27:2014
–8– 60601-2-27  IEC:2011

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:

“Replacement” means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.

“Addition” means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.

“Amendment” means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term “this standard” is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

201.2 Normative references

Clause 2 of the general standard applies, except as follows:

Replacement:
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 –9–

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests

IEC 60601-1-8:2008, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems

Addition:

IEC 60601-2-2:2009, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories

IEC 60601-2-25:___ 2) Medical electrical equipment – Part 2-25: Particular requirements for
the basic safety and essential performance of electrocardiographs

IEC 60601-2-49___ 3) , Medical electrical equipment - Part 2-49: Particular requirements for
the basic safety and essential performance of multifunction patient monitoring equipment

NOTE Informative references are listed in the bibliography beginning on page 68.

201.3 Terms and definitions

NOTE An index of defined terms is found beginning on page 69.

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:

Replacement:

201.3.63
ELECTROCARDIOGRAPHIC ( ECG ) MONITORING EQUIPMENT
ME EQUIPMENT
device including ELECTRODES , LEAD WIRES and interconnecting means for the monitoring
and/or recording of heart action potentials from one PATIENT and displaying the resultant data

NOTE An ECG telemetry transmitter and receiver including its associated display of one PATIENT ’ S data forms an
ME EQUIPMENT . E CG telemetry is typically used to display that data of a PATIENT at a remote location.
Implementations of these remote displays frequently display data from several PATIENTS at the same time, but
logically separate the data of each PATIENT on such a display.

Additional definitions:

201.3.201
COMMON MODE REJECTION ( CMR )
ability of the ME EQUIPMENT including the PATIENT CABLE and ELECTRODES , high frequency
filters, protection networks, amplifier input, etc., to discriminate between signals with
differences between amplifier inputs (differential signal) and signals common to the amplifier
inputs (common signal), in the presence of an ELECTRODE impedance imbalance

201.3.202
ELECTRODE
sensor in contact with a specified part of the body to detect electrical cardiac activity

—————————
2) Second edition, to be published.

3) Second edition, to be published.

 BS EN 60601-2-27:2014
– 10 – 60601-2-27  IEC:2011

201.3.203
ELECTROCARDIOGRAM ( ECG )
graphical presentation of one or more LEADS over time

201.3.204
GAIN
ratio of the amplitude of the output signal to the amplitude of the input signal

NOTE G AIN is expressed in mm/mV

201.3.205
GAIN INDICATOR
graphical indication on a PERMANENT DISPLAY or NON - PERMANENT DISPLAY that allows the
clinical OPERATOR to visually estimate the amplitude of the ECG input signal

201.3.206
LEAD
voltage between ELECTRODES

201.3.207
LEAD SELECTOR
system to select certain LEADS

201.3.208
LEAD WIRE
cable connected between an ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT

201.3.209
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits, not intended
to be used to calculate any LEAD

NOTE A NEUTRAL ELECTRODE is sometimes referred to as a reference ELECTRODE .

201.3.210
NOISE
unwanted signals of any frequency present in the ELECTROCARDIOGRAM

201.3.211
NON - PERMANENT DISPLAY
a non-persistent presentation of an ELECTROCARDIOGRAM ( ECG )

NOTE An example of NON - PERMANENT DISPLAY is a LCD screen across which an ECG waveform is moving or a
transient presentation of an ECG waveform.

201.3.212
PATIENT CABLE
multiwire cable used to connect LEAD WIRES to ME EQUIPMENT

201.3.213
PERMANENT DISPLAY
a persistent presentation of an ELECTROCARDIOGRAM ( ECG )

NOTE Examples of PERMANENT DISPLAYS are hardcopy printouts of an ECG .

201.4 General requirements

Clause 4 of the general standard applies, except as follows:

BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 11 –

201.4.3 E SSENTIAL PERFORMANCE

Addition:

201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

Additional ESSENTIAL PERFORMANCE requirements for ELECTROCARDIOGRAPHIC MONITORING

EQUIPMENT are found in the subclauses listed in Table 201.101

Table 201.101 – E SSENTIAL PERFORMANCE requirements

Requirement Subclause
Defibrillator protection 201.8.5.5.1
Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT 201.11.8
Protection against depletion of battery 201.11.8.101
E SSENTIAL PERFORMANCE of ME EQUIPMENT 201.12.1.101
Electrosurgery interference 202.6.2.101
Time to alarm for heart rate ALARM CONDITIONS 208.6.6.2.103
T ECHNICAL ALARM CONDITIONS indicating inoperable ME EQUIPMENT 208.6.6.2.104

201.5 General requirements for testing of ME EQUIPMENT

Clause 5 of the general standard applies, except as follows:

201.5.4 Other conditions

Addition:

Unless otherwise stated, tests shall be carried out with the ACCESSORIES and the recording
materials specified by the MANUFACTURER .

For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE , if the test result is affected by
the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be performed using the
least favourable INTERNAL ELECTRICAL POWER SOURCE voltage specified by the MANUFACTURER .
If necessary for the purpose of conducting the test, an external battery or d.c. power supply
may be used to provide the necessary test voltage.

The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:

– resistors: ±1 %;
– capacitors: ±10 %;
– inductors: ±10 %;
– test voltages: ±1 %

201.5.8 *Sequence of tests

Amendment:

Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard
shall be carried out prior to the LEAKAGE CURRENT and dielectric strength tests described in
subclauses 8.7 and 8.8 of the general standard and prior to the tests specified in subclauses
201.11.6.5 and 201.12.1.101 of this particular standard. The tests for subclauses
201.12.1.101.7, 201.12.1.101.9 and 201.12.1.101.16 b) shall be performed (in that order)
before the tests for the remaining subclauses of 201.12.1.101 are performed.
 BS EN 60601-2-27:2014
– 12 – 60601-2-27  IEC:2011

201.6 Classification of ME EQUIPMENT and ME SYSTEMS

Clause 6 of the general standard applies, except as follows:

201.6.2 *Protection against electric shock

Replacement of the last paragraph:

A PPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general
standard). A PPLIED PARTS shall be classified as DEFIBRILLATION - PROOF APPLIED PARTS (see
8.5.5 of the general standard).

201.6.6 Mode of operation

Replacement:

M E EQUIPMENT shall be classified for CONTINUOUS OPERATION (see 7.2.11 of the general
standard).

201.7 M E EQUIPMENT identification, marking and documents

Clause 7 of the general standard applies, except as follows:

201.7.2.4 ACCESSORIES

Addition:

201.7.2.4.101 Marking of LEAD WIRES

In order to minimize the possibility of incorrect connections the PATIENT CABLE where the LEAD
WIRES are connected shall be permanently marked with at least one of the identifiers
( ELECTRODE identifier and/or colour code) specified in Table 201.102. Both ends of detachable
LEAD WIRES shall be permanently marked with the same identifiers.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 13 –

Table 201.102 – E LECTRODES and NEUTRAL ELECTRODE ,

their position, identification and colour

Code 1 (usually European) Code 2 (usually American) E LECTRODE position on body surface
L EAD E LECTRODE E LECTRODE E LECTRODE E LECTRODE
System Identifier Colour code Identifier Colour code
R Red RA White Right arm
Limb L Yellow LA Black Left arm
F Green LL Red Left leg
C White V Brown Single movable chest electrode
C1 White/red V1 Brown/Red Fourth intercostal space at right border
of sternum
C2 White/yellow V2 Brown/Yellow Fourth intercostal space at left border
of sternum
Chest
accord- C3 White/green V3 Brown/Green Fifth rib between C2 and C4
ing to
Wilson C4 White/brown V4 Brown/Blue Fifth intercostal space on left
midclavicular line
C5 White/black V5 Brown/Orange Left anterior axillary line at the
horizontal level of C4
C6 White/violet V6 Brown/Violet Left midaxillary line at the horizontal
level of C4
I Light blue/red I Orange/Red At the right midaxillary line a
E Light E Orange/Yellow At the front midline a
blue/yellow

Position C Light blue/green C Orange/Green Between the front midline and left
accor- midaxillary line of 45 degrees
ding to
A Light blue/brown A Orange/Brown At the left midaxillary line a
Frank
M Light blue/black M Orange/Black At the back midline a
H Light blue/violet H Orange/Violet On the back of the neck
F Green F Red On the left leg
N or RF Black RL Green Right leg ( NEUTRAL ELECTRODE )
a Located at the transverse level of the ventricles, if known, or otherwise at the fifth intercostal space

201.7.9.2.9 Operating instructions

Addition:

201.7.9.2.9.101 Additional instructions for use

a) The operating instructions shall include the following:
1) the INTENDED USE including the environment of use;
2) that conductive parts of ELECTRODES and associated connectors for APPLIED PARTS ,
including the NEUTRAL ELECTRODE , should not contact any other conductive parts
including earth;
3) instructions for connecting a POTENTIAL EQUALIZATION CONDUCTOR , if applicable;
4) * precautions to take when using a defibrillator on a PATIENT ; a description of how the
discharge of a defibrillator affects the ME EQUIPMENT ; a warning that defibrillator
protection requires use of MANUFACTURER specified ACCESSORIES including
ELECTRODES , LEAD WIRES and PATIENT CABLES . The specification (or type-number) of
such ACCESSORIES (see 201.8.5.5.1) shall be disclosed;
5) advice to the clinical OPERATOR regarding whether the ME EQUIPMENT incorporates
means to protect the PATIENT against burns when used with HIGH -
FREQUENCY ( HF ) SURGICAL EQUIPMENT . Advice shall be given regarding the location of
 BS EN 60601-2-27:2014
– 14 – 60601-2-27  IEC:2011

ELECTRODES and LEAD WIRES etc, to reduce the hazards of burns in the event of a
defect in the neutral electrode connection of the HF SURGICAL EQUIPMENT ;
NOTE ‘Neutral electrode’ here refers to a term defined in 201.3.227 of IEC 60601-2-2.

6) the choice and application of specified PATIENT CABLES and LEAD WIRES ; the choice
and application of ELECTRODES ;
7) * advice regarding testing of the ME EQUIPMENT and ACCESSORIES on a daily basis (by
the clinical OPERATOR ) and on a scheduled basis (as a service activity). Emphasis
should be placed on how the clinician may test visual and auditory ALARM SIGNALS ;
8) explanation of TECHNICAL ALARM CONDITIONS (see 208.6.8.101);
9) explanation of how the heart-rate value may be affected by the operation of cardiac
pacemaker pulses or by cardiac arrhythmias;
10 the default settings (e.g. ALARM SETTINGS , modes, and filter);
11) the configuration procedure that allows the ALARM SIGNAL inactivation states ( ALARM
PAUSED , AUDIO PAUSED , ALARM OFF , AUDIO OFF ) and the function ALARM RESET to be
controlled remotely (see 208.6.11.101), if provided;
12) simple fault finding methods for troubleshooting problems by which the clinical
OPERATOR can locate problems if the ME EQUIPMENT appears to be functioning
incorrectly;
NOTE This relates to simple difficulties, not to technical malfunctions.

13) the amplitude, pulse width, and overshoot of pacemaker pulses that are rejected by
the ME EQUIPMENT (see 201.12.1.101.13);
14) the subsequent operation of the ME EQUIPMENT after interruption of SUPPLY MAINS
exceeding 30 s (see 201.11.8);
15) description of how to disable ALARM SIGNALS for TECHNICAL ALARM CONDITIONS if LEAD
WIRES or modules are intentionally disconnected by the clinical OPERATOR ;

16) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM
when its INTENDED USE includes the monitoring of PATIENTS that are not continuously
attended by a clinical OPERATOR .
b) The following performance characteristics shall be disclosed.
1) Respiration, leads-off sensing and active NOISE suppression. For ME EQUIPMENT
designed to intentionally apply a current to the PATIENT for the purpose of respiration
sensing, leads-off sensing or active NOISE suppression, the MANUFACTURER shall
disclose the waveforms (in the form of voltage, current, frequency, or other
appropriate electrical parameters) which are applied to the PATIENT .
2) Tall T-wave rejection capability. Disclosure shall be made of the maximum T-wave
amplitude that can be rejected, according to subclause 201.12.1.101.17.
3) Heart rate averaging. The type of averaging done to compute the minute heart rate
and, if applicable, the updating rate of the display shall be disclosed.
4) Heart rate meter accuracy and response to irregular rhythm. Disclosure shall be
made of the indicated heart rate, after a 20 s ME EQUIPMENT stabilization period, for
the four types of alternating ECG complexes A1 to A4 described in Figure 201.101.
5) Response time of heart rate meter to change in heart rate. Disclosure shall be
made of the maximum time, to the nearest second and including the update time of
the ME EQUIPMENT , required for the heart rate meter to indicate a new heart rate for a
step increase from 80 1/min to 120 1/min and a step decrease from 80 1/min to
40 1/min. The response time is measured from the time of the first QRS complex of
the new rate to the time the heart rate meter first reads 37 % of the heart rate
indication at 80 1/min plus (a) for the step increase, 63 % of the steady state
indication at 120 1/min or greater, and (b) for the step decrease, 63 % of the steady
state indication at 40 1/min or less.
6) Time to alarm for tachycardia. Disclosure shall be made of the time to alarm for the
two ventricular tachycardia waveforms B1 and B2 shown in Figure 201.101, following
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 15 –

a normal 80 1/min rate with the upper ALARM LIMIT set closest to 100 1/min and the
lower ALARM LIMIT set closest to 60 1/min. Disclosure shall also be made of
ME EQUIPMENT failure to alarm on either of these waveforms. In addition, the time to
alarm shall be disclosed for these waveforms when their amplitudes are one-half and
twice the indicated amplitudes.
7) Pacemaker pulse rejection warning label. The following or a similar warning shall
be displayed in the instructions for use: “WARNING—PACEMAKER PATIENTS. Rate
meters may continue to count the pacemaker rate during occurrences of cardiac
arrest or some arrhythmias. Do not rely entirely upon heart rate meter ALARM
SIGNALS . Keep pacemaker PATIENTS under close surveillance. See this manual for
disclosure of the pacemaker pulse rejection capability of this instrument” (see
201.12.1.101.13).
8) Visual and auditory ALARM SIGNAL disclosure. The MANUFACTURER shall disclose
the location where ALARM SIGNALS are displayed (i.e., central station, bedside, or
both), colour, size, and modulation (flashing), and the frequency or other descriptive
characteristics of the sounds.
9) I NTERNALLY POWERED ME EQUIPMENT . The minimum operating time of the
ME EQUIPMENT shall be disclosed, provided that the battery is new and fully charged.
If rechargeable batteries are used, the MANUFACTURER shall disclose the battery
charge time from depletion to 90 % charge in NORMAL USE and battery conditioning, if
applicable. Specific advice shall be given on how to determine when the battery
needs to be replaced. In addition, the function of the indicator of subclause
201.15.4.4.101 and the battery charging procedure shall also be disclosed.
10) Auxiliary output. Disclosure shall be made regarding proper connection of other
devices to the auxiliary ECG signal output, if provided. The MANUFACTURER shall also
disclose the bandwidth, GAIN and propagation delay time of all auxiliary outputs.
M ANUFACTURERS also shall disclose how internal pacemaker pulses are represented
in the auxiliary output (their inclusion or absence, and whether enhanced pacemaker
pulses are summed with the ECG signal).
11) Pacemaker pulse rejection disabling. If clinical OPERATOR accessible controls are
provided that disable the pacemaker pulse rejection capability of the ME EQUIPMENT ,
the mode selection and whether the pacemaker pulse rejection (see
201.12.1.101.12/13) of the cardiotach is affected by this mode shall be disclosed.
12) Sweep speeds. The available time bases of PERMANENT and NON - PERMANENT
DISPLAYS of the ME EQUIPMENT shall be disclosed.
 BS EN 60601-2-27:2014
– 16 – 60601-2-27  IEC:2011

Grid intervals: 0,2 s, 0,5 mV

A1

IEC 603/11

Ventricular bigeminy; the total duration for the double complex is 1 500 ms; the
rate is 80 1/min if all QRS complexes are counted and 40 1/min if only the larger R
waves or S waves are counted.

A2

IEC 604/11

Slow alternating ventricular bigeminy; the rate is 60 1/min if all QRS complexes
are counted and 30 1/min if only the large complexes are counted.

A3

IEC 605/11

Rapid alternating ventricular bigeminy; the rate is 120 1/min if all QRS complexes
are counted.

A4

IEC 606/11

Bidirectional systoles; the rate is 90 1/min if all QRS complexes are counted and
45 1/min if only the large complexes are counted.

B1
IEC 607/11

Ventricular tachycardia; the amplitude is 1 mV peak-to-valley (p-v) and heart rate

is 206 1/min.

B2

IEC 608/11

Ventricular tachycardia; the amplitude is 2 mV p-v and heart rate is 195 1/min.

NOTE These ECG test patterns (A1-B2) with defined amplitudes and time scale are available from
http://www.physionet.org. G AIN or GAIN controls may be adjusted for each waveform.

Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveforms for
testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6)
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 17 –

201.8 Protection against electrical HAZARDS from ME EQUIPMENT

Clause 8 of the general standard applies, except as follows:

201.8.3 Classification of APPLIED PARTS

Replacement of a), b), and c):

The APPLIED PART shall be a TYPE CF APPLIED PART .

201.8.5.2.3 * P ATIENT leads

Addition:

Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
ELECTRODE , have an air clearance between connector pins and a flat surface of at least
0,5 mm.

Compliance is checked by inspection.

201.8.5.5 D EFIBRILLATION - PROOF APPLIED PARTS

201.8.5.5.1 * Defibrillation protection

Addition:

Protection against the effects of defibrillation shall be provided for ME EQUIPMENT .

For defibrillator testing the ME EQUIPMENT is operated using the PATIENT CABLES as specified
by the MANUFACTURER .

The following requirements and tests apply in addition to the requirements and tests as
specified in 8.5.5.1 of the general standard.

• Common mode test

Addition:

Within 5 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as specified in this particular
standard.

Compliance is checked according to Figure 201.103.

For ME EQUIPMENT of CLASS I, apply the test voltage between all LEAD WIRES , including the
NEUTRAL ELECTRODE , connected together and the PROTECTIVE EARTH TERMINAL . Energize the
ME EQUIPMENT for these tests.

In the case of ME EQUIPMENT of CLASS II and ME EQUIPMENT with an INTERNAL ELECTRICAL

POWER SOURCE , apply the test voltage between all LEAD WIRES , including the NEUTRAL
ELECTRODE , connected together and the FUNCTIONAL EARTH TERMINAL and/or metal foil in close
contact with the ENCLOSURE . Energize the ME EQUIPMENT for these tests.

Test ME EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE , which is rechargeable

from the SUPPLY MAINS with and without the SUPPLY MAINS connection if the ME EQUIPMENT is
capable of operating while connected to SUPPLY MAINS .
 BS EN 60601-2-27:2014
– 18 – 60601-2-27  IEC:2011

Set the GAIN of the ME EQUIPMENT so such that a 5 mV signal produces a maximum display
deflection without clipping the signal. With S2 closed and S3 opened, adjust the 10 Hz sine
wave generator to produce a 5 mV peak-to-valley output signal. Open switch S2 and close S3.

Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to position
B. Leave in position B for 200 ms ± 50 %. Allow recovery to begin by opening S1 to remove
residual voltages from the ME EQUIPMENT .

Immediately close S2 and open S3. Within 5 s, verify that the recorded test signal is not less
than 80 % of the output before application.

Repeat the above test with the polarity of the high voltage source reversed. Repeat the tests
with positive and negative polarities 5 times.

The ME EQUIPMENT shall resume normal operation in the previous operating mode, without
loss of any OPERATOR settings or stored data within 5 s and shall continue to perform its
intended function as specified in this particular standard.

• Differential mode test

Addition:

Within 5 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as described in the this particular
standard.

M E EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE which is rechargeable from the
SUPPLY MAINS shall be tested with and without the SUPPLY MAINS connection if the
ME EQUIPMENT is capable of operating while connected to the SUPPLY MAINS .

Compliance is checked by the following test:

The ME EQUIPMENT is connected to the test circuit shown in Figure 201.102. The test voltage is
applied to each LEAD WIRE in turn with all the remaining LEAD WIRES being connected to earth.
Initially, the test is conducted applying the test voltage between the L (LA) LEAD WIRE and all
remaining LEAD WIRES connected to the N (RL) LEAD WIRE . The ME EQUIPMENT shall be
energized for these tests.

Set the GAIN such that a 5 mV signal produces a maximum display deflection without clipping
the signal. With S2 closed, adjust the 10 Hz sine wave generator to produce a 5 mV peak-to-
valley output signal. Open switch S2.

Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to position
B. Leave in position B for 200 ms ± 50 %.

Open S1 in order to remove residual voltages from the ME EQUIPMENT and allow recovery to
begin.

Immediately close S2. Within 5 s, verify that the recorded test signal is not less than 80 % of
the output before application.

Repeat the test for any other LEAD WIRE according to Table 201.103 with all remaining LEAD
WIRES connected to the N (RL) LEAD WIRE . The discharge test is applied at 20 s intervals in
those cases where more than one discharge is indicated.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 19 –

Table 201.103 – Protection against the effect of defibrillation (test conditions)

P1 P2 L EAD setting Number of

tests
L (LA) R, F, N, C (RA, LL, RL, V) I 1
R (RA) F, L, N, C (LL, LA, RL, V) II 1
5 LEAD W IRES F (LL) L, R, N, C (LA, RA, RL, V) III 1
N (RL) L, R, F, C (LA, RA, LL, V) Standby 1
C (V) L, R, F, N (LA, RA, LL, RL) V 1
L (LA) R, F, or N (RA, LL or RL) I 2
3 LEAD W IRES R (RA) L, F, or N (LA, LL or RL) I 2
F (LL) or N (RL) R, L (RA, LA) II or standby 2
2 LEAD W IRES L (LA) R (RA) I 1

NOTE The column ‘number of tests’ in Table 201.103 only applies to the defibrillation protection test. For other
testing, the number of tests is one.
 BS EN 60601-2-27:2014
– 20 – 60601-2-27  IEC:2011

S2

R R 50 Ω
390 kΩ non-inductive
RV P1

V1 A B
L (LA)

S1

5 kV d.c.
L 500 µH R 100 Ω EUT
RL(d.c.) ≤ 10 Ω non-inductive R (RA)
F (LL)
C (V)
C 32 µ F
N (RL)

P2
IEC 609/11

Components
G Sine wave generator 20 V peak-to-valley of 10 Hz
V1 High voltage source 5 kV d.c.
S1 Switch; max. load 60 A, 5 kV
S2 Switch connecting the signal source, 5 kV
RL d.c. resistance of inductance L
RV Current limiting resistor
P1, P2 Connecting points for EUT (includes PATIENT CABLES )

Test to be conducted with the MANUFACTURER ’ S recommended PATIENT CABLE and LEAD WIRES .

Figure 201.102 – Test of protection against the effects of defibrillation

(differential mode)
(see 201.8.5.5.1)
 Title

The correction applies to the French text only.

BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 21 –
Figure 201.103
BS EN 60601-2-27:2014 – Test of protection against the effects of defibrillation (common mode)

60601-2-27Replace
 IEC:2011 – 21 –
the existing figure by the following new figure:


G G

S2 S2
G

SR2 R
390 kΩ R 50 Ω
RV R 50 Ω
390 kΩnon-inductive
RV P1
non-inductive PL 1(LA)L (LA)
R
V1 390 kΩ R 50 Ω
V1 RV A B non-inductive P 1 L (LA)
A B S3
S1 S3
V1 S1
5 kV d.c. A B R EUT
5 kV d.c. 100Ω R S3 EUT
L 500 µH
S1 non-100Ω R (RA)
RL(d.c.)
L 500 ≤ 10
µHΩ inductive
non-
5 kV d.c. RL(d.c.) ≤ 10 Ω R F (LL)R (RA) EUT
inductive
100Ω
L 500 µH F (LL)
non- C
R (V)
(RA)
RL(d.c.) ≤ 10 Ω
inductive
C 32 µF F (LL)C (V)
C 32 µF N (RL)
P 2 C (V)
N (RL)
C 32 µF P2
N (RL)
P2 F

F IEC 610/11IEC 833/12

Components F
G Sine wave generator 20 V peak-to-valley of 10 Hz
Components
IEC 610/11
Components
V
G High wave
Sine voltage source 520
generator kVVd.c.
peak-to-valley of 10 Hz
1
G
V Sine wave
High generator
voltage source 520kVVd.c.
peak-to-valley of 10 Hz
Ⓕ1 Foil, simulating capacitance for CLASS II EQUIPMENT
V1 High voltage source 5 kV d.c.
Ⓕ
S1 Switch;
Foil, max. load
simulating 60 A, 5 kVfor CLASS II EQUIPMENT
capacitance
Ⓕ
S
Foil, simulating capacitance for CLASS II EQUIPMENT
Switch connecting the signal source, 5 kV
S 12 Switch; max. load 60 A, 5 kV
S Switch; applying
Switch max. loadthe60signal
A, 5 kV
source to LEAD W IRES
S 231 Switch connecting the signal source, 5 kV
S 2L
R Switch
d.c. connecting
resistance the signal source,
of inductance L 5 kV
S3 Switch
May 2012 applying the signal source to LEAD W IRES
S
R3V Switch applying
Current the signal source to LEAD W IRES
limiting resistor
R
R LL d.c.
d.c. resistance
resistance of inductance
of for
inductance L
L
P1 Connecting point EUT (includes PATIENT CABLES )

RV Current
Connectinglimiting
pointresistor
for FUNCTIONAL EARTH TERMINAL and/or metal
P2
foil in contact with ENCLOSURE
P1
P1 Connecting point
Connecting point for for EUT
EUT (includes
(includes PATIENT CABLES ))
PATIENT CABLES

Test to be conducted
Connecting with
Connecting point MANUFACTURER
point for FUNCTIONAL
for ’ S recommended
FUNCTIONAL EARTH
EARTH and/or PATIENT
TERMINAL and/or
TERMINAL metal
metal CABLE and LEAD WIRES .
P2
P2 foil in
foil in contact
contact with
with ENCLOSURE
ENCLOSURE

Figure
Test 201.103
to be – Test
conducted of MANUFACTURER
with protection against
MANUFACTURER ’S the effects PATIENT
S recommended of defibrillation
PATIENT CABLE and(common
CABLE
mode)
LEAD WIRES
LEAD WIRES .
(see 201.8.5.5.1)
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
201.8.5.5.2 Energy reduction test
(see 201.8.5.5.1)
Replacement of Figure 11 by Figure 201.104:
201.8.5.5.2 Energy reduction test

Replacement of Figure 11 by Figure 201.104:

Figure 201.105 – General test circuit

Delete the symbol "F" between the lower part of the schematic and the legend beginning with
"Components".

201.12.1.101.15 * Heart rate range, accuracy, and QRS detection range

Replace the last sentence of the second paragraph with the following:
 BS EN 60601-2-27:2014
– 22 – 60601-2-27  IEC:2011

R 400 Ω
RV non-inductive

V1 E C L (LA)
A B

S
5 kV d.c.
L 25 mH ± 10 %
R 100 Ω EUT
non-inductive
RL (d.c.) ≤ 10 Ω R (RA)
F (LL)
C 32 µF ±10 % C (V)
N (RL)

F D
IEC 611/11

Components

① Energy test equipment

V1 High voltage source 5 kV d.c.

S Switch; max. load 60 A, 5 kV
RL d.c. resistance of inductance L
RV Current limiting resistor
E, F Connecting points for energy test equipment
Connecting points for EUT (includes PATIENT CABLE )
C, D
(Energy test equipment can be a defibrillator tester)

Test to be conducted with the MANUFACTURER ’ S recommended PATIENT CABLE and LEAD WIRES .

Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and

ME SYSTEMS

Clause 9 of the general standard applies.

201.10 Protection against unwanted and excessive radiation HAZARDS

Clause 10 of the general standard applies.

201.11 Protection against excessive temperatures and other HAZARDS

Clause 11 of the general standard applies, except as follows:

BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 23 –

201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS

Addition:

P ORTABLE / TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while

remaining functioning shall be constructed so that, in the event of spillage of liquids
(accidental wetting) no HAZARDOUS SITUATION results from the ingress of liquids.

The ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the
general standard and shall comply with the requirements of this particular standard.

Compliance is checked by the following test:

Place the PORTABLE / TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least
favourable position of NORMAL USE . Subject the ME EQUIPMENT for 30 s to an artificial rainfall of
3 mm/min falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT .

A test apparatus is shown in Figure 3 of IEC 60529.

An intercepting device may be used to determine the duration of the test.

Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE .

Immediately after the above test, verify (by inspection) that any water that entered the
ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT . Verify that the
ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and
does not result in a HAZARDOUS SITUATION .

After this test, verify that the ME EQUIPMENT complies with the requirements of this particular
standard.

201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT

Addition:

If the SUPPLY MAINS to the ME EQUIPMENT is interrupted for 30 s or less, no change of

OPERATOR settings shall occur, including the mode of operation, and all stored PATIENT data
shall remain available.

NOTE The ME EQUIPMENT does not have to be operating during the interruption of the SUPPLY MAINS .

Compliance is checked by observing the ME EQUIPMENT operating mode, OPERATOR settings,

and stored data and interrupting the SUPPLY MAINS for a period of between 25 s and 30 s by
disconnecting the POWER SUPPLY CORD .

If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of
the following:

– reversion to the MANUFACTURER ’ S default settings,

– reversion to the previous RESPONSIBLE ORGANIZATION ’ S default settings or
– reversion to the last settings used.
NOTE Means may be provided to the OPERATOR to select one or more than one of the above options.

Compliance is checked by functional test.

If the ME EQUIPMENT contains an INTERNAL ELECTRICAL POWER SOURCE and the SUPPLY MAINS is
interrupted, the ME EQUIPMENT shall continue normal operation by switching automatically to
 BS EN 60601-2-27:2014
– 24 – 60601-2-27  IEC:2011

operating from its INTERNAL ELECTRICAL POWER SOURCE , and the mode of operation, all
OPERATOR settings and stored data shall not be changed. Power-saving measures may be
taken provided the ME EQUIPMENT continues to conform to this standard.

M E EQUIPMENT shall visually indicate when it is operating from its INTERNAL ELECTRICAL POWER
SOURCE .

Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR settings
and stored data are not changed, that normal operation continues, and that a visual indication
is displayed that the ME EQUIPMENT is operating from its INTERNAL ELECTRICAL POWER SOURCE .
The ‘on-off’ switch needs to remain in the ‘on’ position.

Addition:

201.11.8.101 * Protection against depletion of battery

M E EQUIPMENT powered from an INTERNAL ELECTRICAL POWER SOURCE shall not cause a
HAZARDOUS SITUATION to the PATIENT when the state of discharge can no longer maintain the
NORMAL USE of the ME EQUIPMENT . The ME EQUIPMENT shall provide a TECHNICAL ALARM
CONDITION to inform the clinical OPERATOR about the state of discharge and shall power down
in a controlled manner as follows:

a) The ME EQUIPMENT shall provide a TECHNICAL ALARM CONDITION at least 5 min prior to the
time that the ME EQUIPMENT can no longer function in accordance with the MANUFACTURER ’ S
specification when powered from the INTERNAL ELECTRICAL POWER SOURCE .
Compliance is checked by functional test.
b) When the state of discharge of any INTERNAL ELECTRICAL POWER SOURCE is such that the
ME EQUIPMENT can no longer function in accordance with the MANUFACTURER ’s specification
the ME EQUIPMENT shall power down in a manner which causes no HAZARDOUS SITUATION to
the PATIENT .
Compliance is checked by operating the ME EQUIPMENT from the INTERNAL ELECTRICAL
POWER SOURCE and by functional test.

201.12 Accuracy of controls and instruments and protection against

hazardous outputs

Clause 12 of the general standard applies, except as follows:

201.12.1 Accuracy of controls and instruments

Addition:

201.12.1.101 * E SSENTIAL PERFORMANCE of ME EQUIPMENT

201.12.1.101.1 Accuracy of signal reproduction

Input signals in the range of ±5 mV, varying at a rate up to 125 mV/s, shall be reproduced on
the output with an error of ≤ ±20 % of the nominal value of the output or ±100 µV, whichever
is greater.

Compliance is checked using the test circuit of Figure 201.105.

Open switch S1, close switches S and S2, and set S4 to position B. Connect the signal
generator to apply a triangular wave of 2 Hz to any LEAD WIRE with all other LEAD WIRES
connected to the N (RL) LEAD WIRE (P2) as defined in Table 201.103. Set the GAIN to
10 mm/mV and sweep speed to 25 mm/s. Adjust the signal generator to produce a peak-to-
valley output on the NON - PERMANENT DISPLAY and on the PERMANENT DISPLAY (if provided), that
is 100 % of the full scale peak-to-valley output. Decrease the output of the signal generator by
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 25 –

factors of 2, 5 and 10. The displayed output shall be linear within ± 20 % or ± 100 µV of the full
scale output.

Repeat for each LEAD WIRE and NON - PERMANENT DISPLAYS and PERMANENT DISPLAYS , if provided
until all combinations of LEAD WIRES and display devices have been tested as defined in
Table 201.103.

Connect the signal generator to any LEAD WIRE with all other LEAD WIRES connected to the
N (RL) LEAD WIRE (P2). Adjust the signal generator to apply a 2 mV peak-to-valley input 20 Hz
sinusoidal signal. Set the GAIN to 10 mm/mV and sweep speed to 25 mm/s. Verify that the
output signal is completely visible and the resulting peak-to-valley amplitude is between 16-
24 mm.
 BS EN 60601-2-27:2014
– 26 – 60601-2-27  IEC:2011

3 S3 ± 300 mV

S1 S2 3 A
S4
P5 P4 P1

620 kΩ R (RA) B
R1
100 kΩ
S 4,7 nF L (LA)
0,1%
[910 Ω 0,1%]
R2 F (LL) EUT
100 Ω
0,1%
2
1
C1 (V1 )
P3 P2

C6 (V6 )

47 nF
P6
4
N (RL)
51 kΩ
F 
Text deleted IEC 612/11

Components
① PATIENT CABLE

② Signal generator; output impedance < 1 kΩ and linearity ± 1 %

③ d.c. offset voltage source (300 mV)

④ Shield
R 1,2 Input voltage divider;
S1 Switch, shorts signal source impedance
S2 Switch, shorts unbalance caused by skin impedance
S3 Switch, changes polarity of d.c. offset voltage source
S4 Switch, connects/disconnects the d.c. offset voltage source
S Switch; connects/disconnects the signal generator
P1,2,6 LEAD W IRE connection points
P3,4 ECG input signal
P5 Signal generator; output signal

The shield around the entire test configuration minimizes induction from MAINS VOLTAGE .

The figure illustrates the general test circuit for:

– 201.12.1.101.1 (accuracy of signal reproduction);
– 201.12.1.101.2 (input dynamic range and differential offset voltage);
– 201.12.1.101.3 (input impedance);
– 201.12.1.101.4 (input NOISE );
– 201.12.1.101.5 (multichannel crosstalk);
– 201.12.1.101.6 ( GAIN control and stability);
– 201.12.1.101.7 (sweep speed);
– 201.12.1.101.8 (frequency and impulse response);
– 201.12.1.101.9 ( GAIN indicator)
– 201.12.1.101.11 (baseline reset);
– 201.12.1.101.14 (synchronizing pulse for cardioversion);
– 201.12.1.101.15 (heart rate range, accuracy and QRS detection range);

Figure 201.105 – General test circuit

BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 27 –

201.12.1.101.2 * Input dynamic range and differential offset voltage

With a d.c. offset voltage in the range of ±300 mV and differential input signal voltages of
±5 mV that vary at rates up to 320 mV/s, when applied to any LEAD WIRE , the time-varying
output signal amplitude shall not change by more than ±10 % over the specified range of
d.c. offset.

Compliance is checked using the test circuit of Figure 201.105.

Open switch S1, close switches S and S2 and set S4 at position B. Apply a 16 Hz triangular
or sinusoidal signal to any LEAD WIRE with all other LEAD WIRES connected to the N (RL) LEAD
WIRE (P2) as defined in Table 201.103. Set the GAIN to 10 mm/mV and sweep speed to
25 mm/s. Adjust the signal generator so that the applied input signal produces an output
amplitude of 80% of the full scale channel height. Record the amplitude of this output signal.

Set switch S4 to position A to apply a d.c. offset voltage of +300 mV. Measure the time-
varying output signal amplitude. Verify that this amplitude is within ± 10% of the previously
recorded amplitude over the specified d.c. offset voltage range. Repeat this test for a
d.c. offset voltage of –300 mV by changing the position of switch S3.

Repeat the test for each LEAD WIRE until all combinations of LEAD WIRES have been tested as
defined in Table 201.103.

Repeat the test for each PERMANENT DISPLAY and NON - PERMANENT DISPLAY .

201.12.1.101.3 * Input impedance

The input impedance shall be at least 2,5 MΩ within a d.c. offset voltage range of ±300 mV.
This requirement does not apply to inputs used for measurements other than ECG (i.e.
respiration).

Compliance is checked using the test circuit of Figure 201.105.

Open switch S1, close switches S and S2 and set S4 to position B. Connect the sine wave
signal generator to any tested LEAD (P1 and P2) with all other LEAD WIRES connected to the
N (RL) LEAD WIRE (P6) as defined in Table 201.103. Set the GAIN to 10 mm/mV and sweep
speed to 25 mm/s. Adjust the sine wave generator to produce a sinusoidal signal of 80 % of
full-scale peak-to-valley channel height on any display at a frequency of 0,67 Hz. Record the
displayed output amplitude for this GAIN at the PERMANENT or NON - PERMANENT DISPLAY being
tested. Open S2 and set S4 to position A. Apply a d.c. offset voltage of +300 mV. The
measured signal amplitude shall not decrease by more than 20 % on the output display.
Repeat the test with a d.c. offset voltage of –300 mV. For d.c. offset voltages of +300 mV and
–300 mV, repeat the test for a frequency of 40 Hz.

Repeat the above test for each LEAD WIRE until all combinations of LEAD WIRES have been
tested as defined in Table 201.103.

201.12.1.101.4 Input NOISE

The signal NOISE caused by the ECG amplifier and PATIENT CABLE shall not exceed 30 µV peak-
to-valley referred to the input (RTI) for a period of at least 10 s. Any mains frequency notch
filter, if provided, is to be turned on during this test.

Compliance is checked using the test circuit of Figure 201.107.

The PATIENT CABLE ( S ) specified by the MANUFACTURER shall be used when conducting the
following test:
 BS EN 60601-2-27:2014
– 28 – 60601-2-27  IEC:2011

a) Insert in series with each LEAD WIRE of the PATIENT CABLE a 51 k Ω resistor in parallel with a
47 nF capacitor as shown in Figure 201.107; for this test all the switches S1 to Sn are
open, and the signal generator G and the capacitor C1 are not connected.
b) With the ME EQUIPMENT adjusted for the highest GAIN setting, for the widest bandwidth
setting, and for the switchable filters disabled, verify that the noise on the PERMNANET
DISPLAY and NON - PERMANENT DISPLAY is no greater than 30 µ V peak to valley referred to
input for a period of at least 10 s, for each position of the LEAD SELECTOR .
c) Repeat this test nine more times. Verify that the 30 µV limit is not exceeded for at least
nine of the 10 trials. The 10 trials must be conducted over a time period not to exceed
30 min. The PATIENT CABLE / LEAD WIRES must be motionless during these tests. The PATIENT
CABLE must not be disconnected between trials.

201.12.1.101.5 Multichannel crosstalk

When an input signal limited in amplitude and rate as per 201.12.1.101.2 is applied to
selected LEAD of the multi-channel ME EQUIPMENT , with all other LEAD WIRES connected to the
N (RL) LEAD WIRE , the unwanted output in the unused LEADS shall not be greater than 5 % of
the applied input signal.

For ME EQUIPMENT with standard and/or Frank LEADS , compliance is checked using the test
circuit of Figure 201.105.

a) Open switch S1, close switches S and S2 and set S4 to position B. Connect LEAD WIRES
F (LL), V1 (C1), and if provided, the Frank (E) to P1. Connect all other LEAD WIRES via P2
to the N (RL) LEAD WIRE (see Table 201.102) through a parallel combination of a 51 k Ω
resistor and a 47 nF capacitor.
b) Set the GAIN to 10 mm/mV and sweep speed to 25 mm/s. Configure the ME EQUIPMENT to
display LEADS I, II and III.
NOTE If the ME EQUIPMENT provides fewer than three simultaneous display channels then perform the test
sequentially for each listed LEADS .
c) From the signal generator, apply 2,5 mV peak-to-valley 30 Hz triangular wave between
P1and P2. Record the displayed output signals of LEAD I or Frank LEADS X and Y. Verify
that the resulting value is less than 1,25 mm (5% of the 2,5 mV input signal).
d) Connect the F (LL) LEAD WIRE to P2 and the R (RA) LEAD WIRE to P1. All other LEAD WIRES
remain connected as specified in a). Record the displayed output signals of LEAD I or
Frank LEADS X and Y. Verify that the resulting value is less than 1,25 mm.
e) Connect the R (RA) LEAD WIRE to P2 and the L (LA) LEAD WIRE to P1. All other LEAD WIRES
remain connected as specified in a). Record the displayed output signals of LEAD I or
Frank LEADS X and Y. Verify that the resulting value is less than 1,25 mm.
f) Connect only the C1 (V1) LEAD WIRE to P1 and connect all other LEAD WIRES via P2 to the
N (RL) LEAD WIRE through a parallel combination of a 51 k Ω resistor and a 47 nF capacitor.
Record the displayed output signals of all LEADS . Verify that the resulting value (the
displayed output signal of every LEAD except LEAD C1 (V1) is less than 1,25 mm.
g) Repeat step f) for the C2 (V2) through C6 (V6) LEAD WIRES connected in turn to P1 and
with all other LEAD WIRES connected to P2. Record the displayed output signals of all
LEADS . Verify that the resulting value (the displayed output signal of every LEAD except the
LEAD associated with the LEAD WIRE currently connected to P1) is less than 1,25 mm.

h) Repeat step f) for all other LEAD WIRES .

BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 29 –

i) For Frank leads, connect only the Frank A and F lead wires to P1 and all other lead wires
to P2. The Frank LEADS X and Z must have output signals less than 1,25 mm (5% of the
2,5 mV input signal).

For ME EQUIPMENT with other LEADS , connections of an individual LEAD WIRE to P1 with all other
LEAD WIRES connected to P2 must take into account the sharing of any specific LEAD WIRE with
more than one LEAD before applying the 1,25 mm crosstalk limit.

201.12.1.101.6 G AIN control and stability

M E EQUIPMENT having PERMANENT and NON - PERMANENT DISPLAYS shall provide at least one
fixed GAIN setting of (10 ± 1,0) mm/mV. In addition, continuously variable GAIN control may be
provided, if this mode is clearly indicated on all provided displays.

Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers
accurate to within 0,2 mm.

Open switch S1, close switches S, S2, and set S4 to position B. Connect R (RA) to P1, L (LA)
to P2 and all other LEAD WIRES to P6. With the signal generator, apply a 1 mV 10 Hz peak-to-
valley sinusoidal signal between the R (RA) and L (LA) LEAD WIRES .

For PERMANENT DISPLAYS , the GAIN setting of 10 mm/mV shall produce a displayed signal
amplitude of (10 ± 1,0) mm. Adjust the input signal amplitude if the displayed signal is
saturated or too small to measure, Measure the displayed signal amplitude for all
implemented fixed GAIN settings. Verify that the displayed signal amplitude is within 10 % of
the chosen GAIN setting.

For NON - PERMANENT DISPLAYS , repeat this test for all implemented fixed GAIN settings.
Measure the displayed signal amplitude. Verify that the resulting value is within 10% of the
chosen GAIN setting.

The GAIN change one minute after energizing the ME EQUIPMENT shall not exceed 0,66 % per
minute. The total GAIN change shall not exceed ±10 % for periods of 1 min, 5 min, 30 min and
60 min

Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers
accurate to within 0,2 mm.

After stabilizing at ambient temperature, energize the ME EQUIPMENT . Set the GAIN to
10 mm/mV and sweep speed to 25 mm/s. Apply a 1 mV peak-to-valley 10 Hz signal. Measure
the displayed output amplitude after 1 min, 5 min, 30 min and 60 min. Verify that the
displayed output amplitude varies less than ± 1 mm between any measurements or 0,66 % per
minute. Other fix GAIN settings may be used to determine the GAIN stability of NON - PERMANENT
DISPLAYS . In this case verify that the displayed output amplitude varies less than ± 1 mm
multiplied by factor ‘selected fix GAIN divided by 10 mm/mV’ between any measurements or
0,66 % per minute.

201.12.1.101.7 Sweep speed

M E EQUIPMENT with PERMANENT DISPLAYS shall provide at least one sweep speed of
25 mm/s ±10 %. M E EQUIPMENT with NON - PERMANENT DISPLAYS shall provide at least one
sweep speed that is labelled 25 mm/s and has a waveform aspect ratio as specified in
201.12.1.101.16 at a GAIN setting of 10 mm/mV.

Other sweep speeds may be provided. The MANUFACTURER shall disclose all available sweep
speeds (see 201.7.9.2.9.101 b) 12)). The sweep speed accuracy for any settings shall not
vary by more than ±10 % over the complete horizontal ECG -channel width.
 BS EN 60601-2-27:2014
– 30 – 60601-2-27  IEC:2011

Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers
accurate to within 0,2 mm.

Connect a signal generator between the R (RA) LEAD WIRE and all other LEAD WIRES connected
to the N (RL) LEAD WIRE . Set the GAIN to 10 mm/mV and the sweep speed to 25 mm/s. Apply a
0,5 mV peak-to-valley triangular or sinusoidal signal of 25 Hz ± 1 %.

For PERMANENT DISPLAYS , generate a printout that contains at least 6 s of the applied signal at
this sweep speed. Ignore the signal from the first 1 s interval and measure the distance
between any 25 successive peaks. This distance must be (25 ± 2,5) mm. Repeat the
measurements at least three times along different parts of the printout and verify that these
measurements remain within (25 ± 2,5) mm.

For NON - PERMANENT DISPLAYS , measure the width (in mm) of the waveform portion of the
display at the height of the vertical midpoint of this signal. Using either a time-exposure
photograph of the display or an image captured from the display, count the number of upper
or lower peaks within this image/photograph. Divide the measured width of the waveform
channel (in mm) by the number of peaks (of this 25 Hz signal). This resulting value must be
(1 ± 0.1) mm.

Other available sweep speeds are checked by visual inspection.

201.12.1.101.8 * Frequency and impulse response

The frequency and impulse response of ME EQUIPMENT shall comply with the following
requirements:

a) Frequency response

M E EQUIPMENT shall meet the requirement for a frequency response (bandwidth) of at least
0,67 Hz to 40 Hz when tested with the input signals from methods A and B. For Method A, the
output at 0,67 Hz and 40 Hz shall be within 71 % to 110 % of the output obtained with a 5 Hz
sine wave input signal. For Method B, the output response obtained with the waveform of
Figure 201.106 with a 20 ms base width shall be within 75 % to 100 % of the output obtained
with a base width of 200 ms.

Compliance is checked using the test circuit of Figure 201.105 and application of test
methods A and B. Ensure that the line frequency notch filter, if provided, is turned off for this
test.

If the ME EQUIPMENT provides additional selectable ECG bandwidths or filter settings, then test
each setting appropriately as specified by the MANUFACTURER .

Method A: Open switch S1, close switches S and S2 and set S4 to position B. Set the GAIN to
10 mm/mV and sweep speed to 25 mm/s. Use the signal generator to apply a 5 Hz, 1 mV
peak-to-valley sine wave signal to the R (RA) LEAD WIRE with all other LEAD WIRES connected
to the N (RL) LEAD WIRE . Record the displayed output amplitude in LEAD II for that GAIN on the
PERMANENT or NON - PERMANENT DISPLAY being tested. Verify that at 0,67 Hz and 40 Hz the
output signal amplitude remains within the range of 71 % to 110 % compared to the amplitude
of 5 Hz.

Method B: Close switches S and S2 and set S4 to position B. Set the GAIN to 10 mm/mV and
sweep speed to 25 mm/s. Use the signal generator to apply the waveform of Figure 201.106
with a base width of (200 ± 20) ms to the F (LL) LEAD WIRE with all other LEAD WIRES
connected to the N (RL) LEAD WIRE . Adjust the input signal to produce an output amplitude
equivalent to (20 ± 0,5) mm in LEAD II. Then, without changing the input amplitude, change the
base width to (20 ± 1) ms. The repetition rate, selected to obtain the most irregular pattern of
amplitudes of successive output peaks, may be 1 Hz or lower.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 31 –

For each of 10 consecutive cycles, locate the point of maximum amplitude (M). Locate the
point (P) that lies midway between the peaks of consecutive cycles. Each peak amplitude is
computed as the difference between amplitude M and the baseline value P preceding M. This
amplitude must be within the range 75 % to 100 % (15 mm to 20 mm nominal) of the peak
amplitude recorded for the 200 ms triangular wave input signal.

b) Impulse response

The extended low-frequency response shall not produce a displacement greater than 0,1 mV
RTI, nor a slope exceeding 0,3 mV/s immediately following the end of the impulse on the
output when an input impulse of 0,3 mV•s (3 mV for 100 ms) is applied.

Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers
accurate to within 0,2 mm.

Open switch S1, close switches S and S2 and set S4 to position B. Set the GAIN to 10 mm/mV
and sweep speed to 25 mm/s. Apply an input impulse of 3 mV amplitude and 100 ms duration
to the R (RA) LEAD WIRE with all other LEAD WIRES connected to the N (RL) LEAD WIRE . Verify
that the output baseline following the impulse is displaced no more than 0,1 mV from the
baseline preceding the impulse and that the slope of the response does not exceed 0,3 mV/s
following the end of the pulse. If the applied impulse triggers the pacemaker detector a
modified impulse with a lower amplitude and longer duration but still having a 0,3 mVs area
may be used.

Tbw

1s
IEC 613/11

Key
T bw 20 ms or 200 ms

Figure 201.106 – High frequency response

(see 201.12.1.101.8 a)

201.12.1.101.9 G AIN INDICATOR

A GAIN INDICATOR shall be provided that indicates the amplitude of an input voltage of 1 mV for
each GAIN setting on PERMANENT and NON - PERMANENT DISPLAYS . The amplitude variation in
display output shall be within ±10 % when applying a (1,00 ± 0,01) mV input signal at the
appropriate LEAD . It shall be available for all LEADS . The GAIN setting may be provided
alternatively as a numerical value expressed in mm/mV. M E EQUIPMENT providing only one
fixed GAIN is exempt from the requirement to provide a GAIN INDICATOR .

NOTE Examples of a GAIN INDICATOR are a vertical bar or a horizontal line (gridline, dotted line) representing the
amplitude a 1 mV input signal.

If the GAIN INDICATOR of 1 mV exceeds the channel height the GAIN INDICATOR may be
rescaled. In this case the amplitude of the GAIN INDICATOR shall be indicated.

Compliance is checked using the test circuit of Figure 201.105, the test signal of Figure
201.106 and a ruler or callipers accurate to within 0,2 mm.
 BS EN 60601-2-27:2014
– 32 – 60601-2-27  IEC:2011

Open switch S1, close switches S and S2 and set S4 to position B. Set the GAIN to 10 mm/mV
and sweep speed to 25 mm/s. With the signal generator apply a (1,00 ± 0,01) mV peak-to-
valley triangular or sinusoidal signal of 25 Hz to the R (RA) LEAD WIRE with all other
LEAD WIRES connected to the N (RL) LEAD WIRE . Record the amplitude of the GAIN INDICATOR
and verify that it is within 10 % of the displayed output signal. Repeat the test for all LEADS
and the minimum and maximum GAIN setting.

201.12.1.101.10 * Common mode rejection

A 10 V r.m.s. signal at mains frequency with 200 pF source capacitance, connected between
earth and all LEAD WIRES connected together shall not produce an output signal greater than
10 mm peak-to-valley at a GAIN setting of 10 mm/mV for not less than 15 s. In series with each
ELECTRODE shall be a 51 kΩ resistor in parallel with a 47 nF capacitor. The PATIENT CABLE
specified by the MANUFACTURER shall be used.

Compliance is checked using the test circuit of Figure 201.107 and a ruler or callipers
accurate to within 0,2 mm. The test has to be performed with main frequencies of 50 Hz and
60 Hz.

a) Adjust C t to produce 10 V r.m.s. at mains frequency at point B, while no PATIENT CABLE is

attached (S0 open). The common mode voltage applied to the ME EQUIPMENT is then
10 V rms. Ensure that the line frequency notch filter (if provided) is turned off for this test,
even if this requires special software or a special method of accessing the control over
that filter.
b) Close switches S0 and S2 through S n , open S1, and set S DC to position B. Set the GAIN to
10 mm/mV and the sweep speed to 25 mm/s. Measure the output amplitude for not less
than 15 s period at that GAIN setting. Then open S2 and close all other switches. Repeat
the amplitude measurement. Continue until the measurement has been made with all
LEAD WIRES .

c) Repeat the test with a +300 mV d.c. and –300 mV d.c. offset voltage in series with the
imbalance impedance, by setting S DC to position A and testing with switch S P in each of its
two positions.

The resulting values shall not be greater than 10 mm peak-to-valley. Ensure that the line
frequency notch filter (if provided) is turned off for this test, even if this requires special
software or a special method of accessing the control over that filter.

In Figure 201.107 C 1 and C t simulate the PATIENT ’ S capacitance to ground. The inner shield
reduces the pickup of unwanted extraneous signals. Since the capacitance C x between the
inner and external shields influences both the source capacitance and the common mode
voltage, this capacitance is increased by a trimmer capacitor to 100 pF, equal to the
generator capacitor C 1 . The generator output is increased to 20 V rms , thus providing 10 V rms
at the common mode point B with a source impedance equivalent to 200 pF when the
PATIENT CABLE is not connected to the test circuit. The shield of the PATIENT CABLE must not be
connected.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 33 –

SP

3 ± 300 mV

C1 S1 A
100 pF S0 SDC
B R

C B
R (RA)
S2

R L (LA)
EUT
C
1
F (LL)
Ct

G
2
C1 (V1)

Sn

R Cn (Vn)

R N (RL)

C
Cx
(stray) 4 5

IEC 614/11

Components

① Signal generator 20 V rms mains frequency

② P ATIENT CABLE

③ DC offset source, impedance ≤ 1 kΩ

④ Inner shield

⑤ Outer shield
B Common mode point
S1-Sn Switches; invoke unbalance circuit consisting of C and R
C 47 nF
R 51 kΩ

Figure 201.107 – Test circuit for COMMON MODE REJECTION

(see 201.12.1.101.10)

201.12.1.101.11 Baseline reset

Means shall be provided for restoring the ME EQUIPMENT to its normal operating condition
within 3 s after applying a 1 V peak-to-valley 50/60 Hz overload voltage for at least 1 s.

Compliance is checked by the following test:

a) Connect the ME EQUIPMENT to the test circuit of Figure 201.105 with switches S, S1 and S2
closed, S4 in position B and the generator circuit of Figure 201.108 with switch S closed
and S1 open; adjust the sinusoidal generator V1 to produce a 10 Hz, 1 mV peak-to-valley
signal between the selected LEAD WIRES ;
b) Select any available LEAD and corresponding LEAD WIRE combination, and by means of
opening the switch S and closing the switch S1 in Figure 201.108, apply a 50/60 Hz, 1 V
peak-to-valley overload voltage for at least 1 s;
c) Close switch S and open switch S1 in Figure 201.108 and verify that the 10 Hz signal is
clearly visible 3 s after closure of the switch across V2 and remains visible.
 BS EN 60601-2-27:2014
– 34 – 60601-2-27  IEC:2011

V1

S1

V2 S

IEC 615/11

Components
V1 Signal generator 1 mV peak-to-valley, 10 Hz sine wave
V2 Signal generator 1 V peak-to-valley, 50Hz/60 Hz mains frequency
S Switch enabling/disabling 50 Hz/60 Hz mains frequency

Figure 201.108 – Baseline reset

(see 201.12.1.101.11)

201.12.1.101.12 * Pacemaker pulse display capability

M E EQUIPMENT shall be capable of displaying the ECG signal in the presence of pacemaker
pulses with amplitudes of ±2 mV to ±700 mV and durations of 0,5 ms to 2,0 ms. An indication
of the pacemaker pulse shall be visible on the display with an amplitude of no less than
0,2 mV referred to input (RTI). Alternatively, the position of pacemaker pulses may be
indicated by artificially inserted pacemaker pulse flags. If the display capability of pacemaker
pulses is affected by patient modes such as neonatal mode or filter settings the positions of
these inserted pacemaker flags in these modes shall be verified.

Compliance is checked using the test circuit of Figure 201.114 and the waveform of Figure
201.109.

Connect the R (RA) LEAD WIRE to P1 and all other LEAD WIRES and N (RL) LEAD WIRE to P2. Set
the GAIN to 10 mm/mV and sweep speed to 25 mm/s. Apply with the pacemaker pulse
generator (2) the waveform of Figure 201.109. The QRS simulator (1) is switched off for this
test. Adjust amplitude a p of the pacemaker pulse to (700 ± 70) mV. Adjust the pacemaker
pulse frequency to 1,5 Hz. Adjust the pulse width d p to (2 ± 0,2) ms. Verify that the indication
of the pacemaker pulse is visible on the display with an amplitude of at least 0,2 mV RTI or
that position of pacemaker pulses may be indicated by inserted pace pulse flags.

Adjust the pulse width d p to (0,5 ± 0,05) ms and repeat the test.

Change the amplitude a p of the pacemaker pulse to (2 ± 0,02) mV and repeat all the above
tests.

Repeat the test for all other LEAD WIRES and corresponding LEAD SELECTOR positions as
defined in Table 201.103. Repeat the test for all modes that may affect the capability of
displaying pacemaker pulses or artificially inserted pacemaker flags.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 35 –

dp dp

a) b)

ap ap
App
to to

Aus
ao
ao

IEC 616/11
Key
A Pacemaker pulse without overshoot
B Pacemaker pulse with overshoot (a.c. coupled, area A pp = A us )
ap Amplitude (variable from 2 mV to 700 mV)
ao Overshoot (see text)
dp Pulse width (variable from 0,1 ms to 2,0 ms)
to Overshoot time constant (4 ms to 100 ms)

Rise and fall times of the pacemaker pulse shall not exceed 10 % of d p or 100 µs.

Figure 201.109 – Pacemaker pulse

(see 201.12.1.101.12)

201.12.1.101.13 Rejection of pacemaker pulses

Disclosure (see subclause 201.7.9.2.9.101 b) 7)) shall be made of whether the ME EQUIPMENT
rejects all pacemaker pulses having amplitudes (a p ) from ±2 mV to ±700 mV and pulse widths
from 0,1 ms to 2,0 ms. If the ME EQUIPMENT cannot effectively reject pacemaker pulses in this
range, disclosure shall be made of the range of pulse amplitudes and widths that the
ME EQUIPMENT can reject. The ME EQUIPMENT ' S pacemaker pulse rejection capability shall be
disclosed for

a) pacemaker pulses alone of the form shown in Figure 201.109;

b) pacemaker pulses with a normally paced QRS and T-wave (Figure 201.111); and
c) pacemaker pulses with an ineffectively paced QRS pattern (Figure 201.112).

Disclosure of rejection capability also shall be made for (a), (b), and (c) above when an atrial
pacemaker pulse with identical amplitude and duration precedes a ventricular pacemaker
pulse by 150 ms to 250 ms.

If means are provided to disable the pacemaker pulse rejection capability of the
ME EQUIPMENT , a visible indication shall be displayed to inform the clinical OPERATOR that the
pacemaker pulse rejection is disabled.

The applied test signals of Figure 201.109 shall be as follows:

– method A - test signal a) for pacemaker pulses without overshoot: the overshoot (a o ) shall
be less than 5 % of pacemaker amplitude (0,05 a p in Figure 201.109), and the settling
time of the overshoot must be less than 5 µs; the rise and fall times shall be 10 % of the
pulse width, but not greater than 100 µs. The rising edge of the pacemaker pulse shall
occur between 10 ms and 40 ms before the onset of the QRS complex as outlined in
Figure 201.111;
 BS EN 60601-2-27:2014
– 36 – 60601-2-27  IEC:2011

– method B - test signal b) for pacemaker pulses with overshoot: same signal as specified in
test signal of method A but the overshoot (a 0 ) shall have recharge time constants (t 0 )
between 4 ms and 100 ms.

Compliance is checked by using the test circuit of Figure 201.114 and the signal generator
waveform of Figures 201.109, 201.111, 201.112, and 201.113.

In Figure 201.114 connect LEAD WIRE R (RA) to position P1 and all other LEAD WIRES to
position P2.

If the MANUFACTURER ’S specifications for the ME EQUIPMENT encompass anything other than
this particular standard’s full ranges (amplitude = ± 2 mV to ± 700 mV, duration = 0,1 ms to
2 ms, and overshoot = 4 ms to 100 ms, as defined by method A and method B), perform the
following tests using the amplitudes, durations and overshoots specified by the
MANUFACTURER .

a) Apply the waveform of Figures 201.109/201.111 to the ME EQUIPMENT input, with QRS
amplitude (a) in Figure 201.113 set at 1 mV, QRS duration (d) at 100 ms, and from Figure
201.110, T-wave amplitude (a T ) at 0,2 mV, T-wave duration (d T ) at 180 ms, QT interval
(d QT ) at 350 ms, and R-R interval at 1 s. Set the amplitude of the pacemaker pulse to
+2 mV. Adjust the pulse width (d P ) to 2 ms.
b) The GAIN control, if provided, may be adjusted only at this point in the test sequence.
c) Verify that the indicated heart rate agrees with the values disclosed by the MANUFACTURER .
d) Remove the QRS and T-wave signal and verify that the indicated heart rates agree with
those disclosed by the MANUFACTURER .
e) Repeat the above steps a), c) and d) for pacemaker pulse amplitudes (a P ) of –2 mV,
± 100 mV, ± 300 mV, ± 500 mV, ± 700 mV.
f) Apply the test waveform of Figure 201.112 to the ME EQUIPMENT input with the same
parameters as in step a) except that the heart rate is set to 30 1/min and the pacing rate
to 80 1/min (during this test, the heart rate must be such that the pacemaker pulse to drifts
asynchronously through the ECG waveform).
g) Apply a pulse with amplitude and duration identical to the ventricular pacemaker pulse, but
preceding the latter by 150 ms, and repeat steps (a) through (f) with both pacemaker
pulses present.
h) Repeat step (g) using an interval of 250 ms instead of 150 ms between pacemaker pulses.
i) Verify that the indicated heart rate agrees with the values disclosed by the MANUFACTURER .
j) Repeat steps (f), (g) and h) for a P of –2 mV, ± 100 mV, ± 300 mV, ± 500 mV, and ± 700 mV.
k) Repeat the entire test sequence for pacemaker pulses having the parameters of the
described test signal (b). The amplitude of the overshoot (a 0 ) may be set based on either
method A (= 0,025 a P to 0,25 a P , but not to exceed 2 mV, independent of time constant),
method B (= a P d P /t 0 ), or both.
NOTE For method B, capacitive coupling may cause the main pulse to sag by an amount equal to the
overshoot's amplitude. Also, with A-V sequential pacemaker pulses, the overshoot of the ventricular pulse must
include any residual left over from unsettled overshoot of the atrial pulse.
l) Repeat tests a) through k) for a pulse width (d P ) of 0,1 ms.
m) If the ME EQUIPMENT behaves differently for the above tests while in different PATIENT
modes (particularly neonate mode), repeat this test in all PATIENT modes.

If means are provided that disable the pacemaker pulse rejection capability, activate these
means and verify display of a visual indication that pacemaker pulse rejection is disabled.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 37 –

ar aT

as

d dT

dQT

A1
aT

A2 aT

IEC 617/11

Key
ar Amplitude of QR segment
as Amplitude of RS undershoot
aT Amplitude of T-wave
d Duration of QRS
dT Duration of T-wave
d QT Duration of QT segment

Figure 201.110 – Test waveforms for T-wave rejection

(see 201.7.9.2.9.101 b)2), 201.12.1.101.13, 201.12.1.101.17)

a
aT

10 - 40 ms dT
d
IEC 618/11

Figure 201.111 – Normal paced rhythm

(see 201.12.1.101.13 and Figure 201.113
 BS EN 60601-2-27:2014
– 38 – 60601-2-27  IEC:2011

IEC 619/11

IEC 619//11
Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at 80 1/min)
(see 201.12.1.101.13)

0,875 a (ar)
a

0,4375 d 0,125 a (as)

0,5 d
0,0625 d
d
IEC 620/11

Figure 201.113 – Simulated QRS complex

(see 201.12.1.101.13, 201.12.1.101.14 and 201.12.1.101.15)

100 kΩ
0,1% P1 R (RA)

910 Ω

1 100 Ω 2 P2 EUT
0,1%

N (RL)

IEC 621/11
Components

① QRS simulator; output impedance < 1 kΩ and linearity ± 1 %; 1 V peak-to-valley, 40 Hz

② Pacemaker pulse generator; pulse amplitude 2,5 V, duration 2 ms and frequency of 1,7 Hz

NOTE Adjust pulse amplitude and duration as specified in 201.12.1.101.12 and 201.12.1.101.13.

Figure 201.114 – Pacemaker test circuit

201.12.1.101.14 Synchronizing pulse for cardioversion

If a pulse is available on a SIGNAL OUTPUT PART in order to synchronize a defibrillator

discharge, the time interval from the R wave peak to the start of the synchronizing pulse shall
not be greater than 35 ms. Pulse characteristics of amplitude, duration, shape and output
impedance shall be disclosed in the ACCOMPANYING DOCUMENTS .

Check for compliance using the test circuit of Figure 201.105 and the waveform of Figure
201.113.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 39 –

In Figure 201.105, open switch S1, close switches S and S2 and set S4 to position B.
Connect the signal generator with the waveform of Figure 201.113 to the R (RA) LEAD WIRE .
Connect all other LEAD WIRES to the N (RL) LEAD WIRE . Adjust the signal generator to a
frequency of 1 Hz. Apply QRS amplitudes (a) of 0,5, 2,0 and 5,0 mV sequentially; For each
amplitude (a) set the QRS duration d to 70 ms, 100 ms, 120 ms and to 40 ms for
neonatal/paediatric ME EQUIPMENT .

Verify that the leading edge of the synchronizing pulse output occurs no later than 35 ms from
the peak of the R wave of the input signal.

201.12.1.101.15 * Heart rate range, accuracy, and QRS detection range

M E EQUIPMENT shall be equipped with means to detect and display the heart rate.

The heart rate display range shall be at least 30 1/min to 200 1/min for adults and 30 1/min to
250 1/min for neonatal and paediatric use. The accuracy of the detected heart rate shall be
±10% or ±5 1/min, whichever is greater. E CG input signals at rates that are lower than the
specified lower display range limit shall not indicate a heart rate greater than this lower limit.
E CGEinput
 cg input signalsatat rates
signals rates above
abovethe upper
the limitlimit
upper of theofspecified display display
the specified range, uprange,
to 300 up
1/minto
for
300adults
1/min and 350 1/min
for adults and for
350neonatal
1/min forand paediatric
neonatal and use shall not
paediatric usedetect
shall heart rates heart
not detect lower rates
than
the specified
lower upper
than 300 limits.
1/min for adults
 and 350 1/min for neonatal and paediatric use.

The minimum detection range of QRS amplitudes (a in Figure 201.113) shall be 0,5 mV to
5 mV for durations of the QRS wave between 70 ms and 120 ms (40 ms and 120 ms for
neonatal/paediatric ME EQUIPMENT ). For ME EQUIPMENT set for adult PATIENTS , the heart rate
meter shall not respond to ECG signals having a QRS amplitude of 0,15 mV or less, or a
duration of 10 ms or less with an amplitude of 1 mV. Response to either or both of these types
of signals is permitted in ME EQUIPMENT set for neonatal/paediatric PATIENTS .

Check for compliance using the test circuit of Figure 201.105 and the waveform of Figure
201.113.

Open switch S1, close switches S and S2 and set S4 to position B. With the signal generator
apply the waveform of Figure 201.113 to the R (RA) LEAD WIRE with an amplitude (a) of 1 mV.
For adult use, set the ORS duration (d) to 70 ms and to 120 ms. For neonatal or paediatric
use, set the QRS duration (d) to 40 ms and 120 ms. Connect all other LEAD WIRES to the
N (RL) LEAD WIRES . Set the GAIN to 10 mm/mV and the sweep speed to 25 mm/s.

Slowly vary the input signal heart rate from zero to 30 1/min pausing every 10 1/min to allow
the displayed heart rate to stabilize. The displayed heart rate for values within the specified
display range shall be within ± 5 1/min. For input signal rates below the specified low limit, the
displayed heart rate shall not exceed the specified low limit..

Apply a signal rate of 300 1/min, and a signal rate that is one-half the sum of 300 1/min and
the specified maximum rate. For neonatal/paediatric use, these rates are 350 1/min and a
signal rate one-half the sum of 350 1/min and the specified maximum rate. The displayed
heart rate shall not be less than the specified upper limit of the display range.

Accuracy requirements:

Vary the input signal rate from 0 1/min to 200 1/min for adult use and to 250 1/min for
neonatal or paediatric use. Use intermediate input signal rates of 30 1/min, 60 1/min,
120 1/min, and 180 1/min. The displayed heart rate shall be within ± 10 % or ± 5 1/min,
whichever is greater, of the input signal rate.

Repeat the test with amplitudes (a) of the input signal of Figure 201.113, 0,5 mV, 2,0 mV, and
5,0 mV. For each amplitude (a), set the QRS duration (d) in Figure 201.113 to 70 ms, 100 ms,
 BS EN 60601-2-27:2014
– 40 – 60601-2-27  IEC:2011

and to 120 ms for adult use. For neonatal or paediatric use, set the QRS durations (d) to
40 ms, 80 ms, and 120 ms.

Repeat the test in adult mode with a QRS amplitude of 0,15 mV and afterwards with a QRS
duration of 10 ms and a QRS amplitude of 1 mV.

The accuracy requirements described above shall be met. In adult mode, the ME EQUIPMENT
shall not count the heart rate when a QRS amplitude of 0,15 mV is applied and when a QRS
duration of 10 ms and a QRS amplitude of 1 mV is applied.

Place a sinusoidal voltage of 100 µV peak-to-valley at mains frequency in series with the
signal generator of Figure 210.105. Set the amplitude (a) of the waveform in Figure 201.113
to 1 mV and its duration (d) to 100 ms with a repetition rate of 80 1/min. Ensure that the line
frequency notch filter, if provided, is on for the test. Vary the input signal rates as described
above. The indicated rate shall meet the accuracy requirements.

201.12.1.101.16 * Channel height and aspect ratio

The output display of the ME EQUIPMENT shall accommodate the ECG signals specified in
201.12.1.101.2, and shall comply with the following additional requirements.

a) Channel height. M E EQUIPMENT shall provide means to display an ECG signal that meets
the following requirements.
For PERMANENT DISPLAYS , within a vertical space of at least 20 mm per ECG channel.
For NON - PERMANENT DISPLAYS , within a vertical space of at least:
– 10 mm per ECG channel for ME EQUIPMENT with an INTENDED USE that includes transport
monitoring or being PATIENT worn.
– 30 mm per ECG channel for ME EQUIPMENT with any other INTENDED USE .
Other channel height selections may be provided.
Compliance is checked as follows:
Apply a sinusoidal or triangular test signal at any frequency between 1 Hz and 40 Hz.
Adjust the input amplitude to produce an output deflection covering the expected full
channel height of the output display area for the ECG channel being tested. Verify that the
amplitude is no less than the value indicated above depending on the INTENDED USE for
that type of PERMANENT DISPLAY or NON - PERMANENT DISPLAY . Repeat this test for each
provided ECG channel. Verify alternate channel heights in a similar fashion.
b) Aspect ratio. The aspect ratio of PERMANENT and NON - PERMANENT DISPLAYS shall be
(0,4 ± 0,08) s/mV, where aspect ratio is defined as the ratio of vertical GAIN (in mm/mV) to
sweep speed (in mm/s). For ME EQUIPMENT providing several different aspect ratios or
adjustable aspect ratios, an aspect ratio of (0,4 ± 0,08) s/mV shall be among those
provided (at 10 mm/mV and 25 mm/s, the aspect ratio is 0,4).
Compliance is checked as follows:
Apply a 1 mV peak-to-valley sinusoidal or triangular signal at a frequency of 1,0 Hz.
Measure the amplitude of the displayed signal (A) in mm peak-to-valley. Measure the
length (B) in mm along the display for one complete waveform cycle. The ratio A/B must
be 0,4 ± 0,08.

201.12.1.101.17 Tall T-wave rejection capability

Disclosure shall be made of the maximum T-wave amplitude (a T ) for which heart rate
indication is within the error limits specified in 201.12.1.101.15. If the maximum T-wave
amplitude (a T ) that can be rejected is affected by bandwidth chosen, also disclose separately
the maximum T-wave amplitude rejected for each bandwidth.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 41 –

Use a QRS test signal (Figure 201.110) of 1 mV amplitude (a) and 100 ms duration (d), with a
heart rate of 80 1/min, a T-wave (positive half of a sine wave) duration (d T ) of 180 ms, and QT
interval (d QT ) of 350 ms. Allow ME EQUIPMENT to stabilize for at least 20 s before testing.

201.12.3 Alarm systems

Addition:

M E EQUIPMENT shall be equipped with an ALARM SYSTEM as specified in Clause 208 of this
particular standard.

201.12.4 Protection against hazardous output

201.12.4.101.1 Indications on PERMANENT DISPLAYS and NON - PERMANENT DISPLAYS

E CG related clinical OPERATOR settings that may affect the interpretation of ECG waveforms
shall be indicated on PERMANENT DISPLAYS and NON - PERMANENT DISPLAYS . At least the
following settings shall be indicated:

a) any filter settings;

b) selected LEAD / S ;
c) GAIN INDICATOR (see 201.12.1.101.9);
d) sweep speed (on PERMANENT DISPLAYS only);
NOTE ECG waveforms presented on PERMANENT DISPLAYS appear on a grid (see IEC 60601-2-25 subclause
201.12.4.109.4.5).

201.13 H AZARDOUS SITUATIONS and fault conditions

Clause 13 of the general standard applies.

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS )

Clause 14 of the general standard applies.

201.15 Construction of ME EQUIPMENT

Clause 15 of the general standard applies, except as follows:

201.15.3.4 Drop test

Addition:

201.15.3.4.101 * E LECTRODES and PATIENT CABLES

E LECTRODES and PATIENT CABLES , which contain electronic components, shall not present a
HAZARDOUS SITUATION and shall continue functioning normally after falling freely from a height
of 1 m onto a hard surface.

Testing need not be performed if examination of the construction and circuit arrangement
shows that no HAZARDOUS SITUATION is possible and that normal function will not be impaired.

Compliance is checked by the following test:

Allow the test sample to fall freely once from each of three different starting attitudes from a
height of 1 m onto a 50 mm thick hardwood board (for example, hardwood >700 kg/m³), which
lies flat on a rigid base (concrete block).
 BS EN 60601-2-27:2014
– 42 – 60601-2-27  IEC:2011

After this test, no parts shall become accessible that exceed the values of the
LEAKAGE CURRENTS when touched with the test finger. Cracks not visible to the naked eye and
surface cracks in fibre-reinforced mouldings and the like shall be ignored. After this test all
requirements of this particular standard shall be satisfied and the ME EQUIPMENT shall function
normally.

201.15.4.4 Indicators

Addition:

201.15.4.4.101 Indicator of battery operation and battery status

M E EQUIPMENT shall visually indicate when it is operating from its INTERNAL ELECTRICAL POWER
SOURCE , unless it is only INTERNALLY POWERED .

I NTERNALLY POWERED ME EQUIPMENT shall visually indicate its remaining battery capacity when
operating from its INTERNAL ELECTRICAL POWER SOURCE .

Compliance is checked by inspection and measurement.

201.16 M E SYSTEMS

Clause 16 of the general standard applies.

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

Clause 17 of the general standard applies, except as follows:

See Clause 202.

202 Electromagnetic compatibility – Requirements and tests

IEC 60601-1-2:2007 applies except as follows:

202.5.2.2.2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS other than those

specified for use only in a shielded location

Addition:

E LECTROCARDIOGRAPHIC MONITORING EQUIPMENT and its ACCESSORIES shall not be considered

LIFE - SUPPORTING ME EQUIPMENT .

202.6 E LECTROMAGNETIC COMPATIBILITY

202.6.1 E MISSIONS

202.6.1.1.2 Tests
a) P ATIENT cables

Replacement:

M E EQUIPMENT shall be tested with the PATIENT CABLE / S as specified by the MANUFACTURER
with all SIP / SOP cables connected to ME EQUIPMENT (see Figure 202.101); the distances of
SIP / SOP cables between the open end and floor (ground plane) shall be ≥ 40 cm. If the
MANUFACTURER specifies PATIENT CABLES with different lengths only one representative sample
of each length has to be tested.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 43 –

The RC network (C P , R P ) and the metal plate (7) of Figure 202.101 are not used during
radiated emissions testing.

Dimensions in m

>1 1 0,5 0,3

EUT
1
4 7
1 5
0,3
CP
3 6
0,05 RP

≥ 0,4

IEC 622/11

Components
① Mains cable
② SIP/SOP cable
③ Table made of insulating material
④ M E EQUIPMENT under test
⑤ PATIENT CABLE

⑥ Load simulating the PATIENT (51 kΩ in parallel with 47 nF)

⑦ Metal plate

CP 220 pF
RP 510 Ω

C P in series with R P simulates the body of the PATIENT .

The RC network (C P , R P ), the load simulating the PATIENT (6), and the metal plate (7) must not be used during
radiated EMISSIONS testing.

Figure 202.101 – Test layout for radiated and conducted EMISSION test
and radiated immunity test
(see 202.6.1.1.2 a) and 202.6.2.1.10)

202.6.2 I MMUNITY

202.6.2.1.10 Compliance criteria

Addition:

M E EQUIPMENT shall comply with subclause 6.2.1.10 of IEC 60601-1-2:2007 and the accuracy
of the detected heart rate shall be ± 10% or ±5 1/min, whichever is greater (see subclause
201.12.1.101.15) except subclauses 202.6.2.2.1 and 202.6.2.101 in this particular standard.

202.6.2.2 E LECTROSTATIC DISCHARGE ( ESD )

202.6.2.2.1 Requirements

Addition:
 BS EN 60601-2-27:2014
– 44 – 60601-2-27  IEC:2011

M E EQUIPMENT may show temporary DEGRADATION during discharges. Within 10 s the

ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of
any OPERATOR settings or stored data, and shall continue to perform its intended function and
maintain ESSENTIAL PERFORMANCE (see 202.6.2.1.10).

202.6.2.3 Radiated RF electromagnetic fields

202.6.2.3.1 Requirements

Addition to item a):

I MMUNITY TEST LEVEL of 3 V/m applies.

202.6.2.3.2 Tests

Addition:

aa) Any SIGNAL INPUT / OUTPUT PART cable and POWER SUPPLY CORD are arranged generally
as in Figure 202.102. Maintain distances of ≥ 40 cm between SIP / SOP cables and the
floor (ground plane).
bb) Perform the test using the simulated input signal of Figure 201.113 with an
amplitude (a) of 1 mV, a duration (d) of 100 ms and a heart rate of 100 1/s.

Dimensions in m

>1 1

0,3
2
EUT 7
1 4 5

3 0,05 6

≥ 0,4

IEC 623/11

Components
① Mains cable
② Signal cable
③ Table made of insulating material
④ M E EQUIPMENT under test
⑤ PATIENT CABLE

⑥ Load simulating the PATIENT (51 kΩ in parallel with 47 nF)

⑦ ECG simulator (shielded and, if necessary, low pass filtered, if susceptible to radio frequency interference)

Figure 202.102 – Set-up for radiated IMMUNITY test

(see 202.6.2.3.2)
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 45 –

202.6.2.4 Electrical fast transients and bursts

202.6.2.4.1 Requirements

Addition:

When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD , the
ME EQUIPMENT shall continue to display the heart rate. The accuracy of the displayed heart
rate shall be ± 10% or ±5 1/min, whichever is greater (see subclause 201.12.1.101.15).

Testing of PATIENT CABLES and interconnecting cables specified to be more than 3 m in length
may show temporary DEGRADATION during exposure of fast transients and bursts. Within 10 s
the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss
of any OPERATOR settings or stored data, and shall continue to display the heart rate. The
accuracy of the displayed heart rate shall be ± 10% or ±5 1/min, whichever is greater (see
subclause 201.12.1.101.15).

202.6.2.4.2 Tests

Addition:

aa) Position ME EQUIPMENT 0,8 m ± 0,08 m above the reference ground plane.

bb) Use the power cord provided with the ME EQUIPMENT to connect ME EQUIPMENT to the
output of the EFT / B generator.

cc) Perform the test using the simulated input signal of Figure 201.113 with an amplitude (a)
of 1 mV, a duration (d) of 100 ms and a heart rate of 100 1/s.

202.6.2.6 Conducted disturbances, induced by RF fields

202.6.2.6.1 Requirements

Addition:

aa) When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD , the
ME EQUIPMENT shall continue to perform its intended function as described in
202.6.2.1.10.
bb) *P ATIENT CABLES are exempt from this requirement.

202.6.2.6.2 Tests

Addition:

aa) Subclause 6.2.6.2, items c) and e) of IEC 60601-1-2:2007 do not apply.

Addition:

202.6.2.101 * Electrosurgery interference

E CG telemetry systems are excluded from this test.

Means shall be provided to protect against malfunction caused by electrosurgery. Perform the
test below, using any PATIENT CABLES , LEAD WIRES , ACCESSORIES or settings recommended by
the MANUFACTURER .

When the ME EQUIPMENT is used together with HF SURGICAL EQUIPMENT it shall return to its
previous operating mode within 10 s after exposure to the field produced by the
HF SURGICAL EQUIPMENT without loss of any stored data.
 BS EN 60601-2-27:2014
– 46 – 60601-2-27  IEC:2011

Compliance is checked according to Figures 202.103 and 202.104.

Use HF SURGICAL EQUIPMENT which complies with IEC 60601-2-2 and has a minimum power
cut mode capability of 300 W, a minimum coagulation mode capability of 100 W and working
frequency of 400 kHz ± 10 %.

a) Test in cut mode:

Set the output power of the HF SURGICAL EQUIPMENT to the 300 W position.
Touch the metal contact/block in the test set-up (see Figures 202.103 and 202.104) with
the ACTIVE ELECTRODE and remove the electrode slowly to get an arc.
Verify whether the ECG baseline returns within 10 s to its normal position and the
ME EQUIPMENT returns to the previous operating mode without loss of any stored data.
Repeat the procedure five times.
b) Test in coagulation mode:
Repeat the test in item a) except with an output power of 100 W.

Test of the spray coagulation mode is excluded.

2
1 5 EUT
3
RS
R (RA)
CS
RS L
Rp F 7
CS
C 6
Rp RS
N N (RL)
Cg CS
4

IEC 624/11

Components
① HF SURGICAL EQUIPMENT

② Metal plate
③ ACTIVE ELECTRODE of the HF SURGICAL EQUIPMENT
④ Metal plate/neutral electrode (N) of HF SURGICAL EQUIPMENT
⑤ Coupling network
⑥ PATIENT CABLE

⑦ M E EQUIPMENT
Rp 500 Ω, 200 W (low-inductive, < 5 µH, simulates patient impedance)
Cg 47 nF (to minimise the effect of different types of HF SURGICAL EQUIPMENT designs)
Rs 51 kΩ R s //C s simulate the skin impedance
Cs 47 nF
R, L, F, C, N LEAD W IRES according to Table 201.103
NOTE The test report should identify the HF SURGICAL EQUIPMENT that was used.

Figure 202.103 – Test circuit for HF surgery protection measurement

(see to 202.6.2.101)
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 47 –

>3
8
2
6
3
0,5
1 5 Cg 7

10
N
4
9

IEC 625/11

Components
① HF SURGICAL EQUIPMENT

② Metal plate
③ ACTIVE ELECTRODE of the HF SURGICAL EQUIPMENT
④ Neutral electrode of the HF SURGICAL EQUIPMENT
⑤ Coupling network – test set-up according to item 5 in Figure 201.103
⑥ PATIENT CABLE

⑦ M E EQUIPMENT under test

⑧ SUPPLY MAINS

⑨ Table made of insulating material

⑩ Connection to PROTECTIVE EARTH CONDUCTOR for grounding

Figure 202.104 – Test setup for HF surgery protection measurement

(see to 202.6.2.101)

208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems

IEC 60601-1-8:2006 applies except as follows (see also alarm diagrams in Annex BB):

208.6 ALARM SYSTEMS

208.6.1 ALARM CONDITION

208.6.1.2 * ALARM CONDITION priority

Addition:

M E EQUIPMENT that includes in its INTENDED USE monitoring of PATIENTS that are not
continuously attended by a clinical OPERATOR in NORMAL USE shall treat ALARM CONDITIONS that
may result in minor injury and delayed onset of potential HARM as LOW PRIORITY
ALARM CONDITIONS (see Table 208.101).
 BS EN 60601-2-27:2014
– 48 – 60601-2-27  IEC:2011

The ACCOMPANYING DOCUMENTS shall describe how the RESPONSIBLE ORGANIZATION may enable
or disable auditory ALARM SIGNALS for LOW PRIORITY ALARM CONDITIONS . The requirements of
6.7 of IEC 60601-1-8:2006 apply.

NOTE This adaptation of Table 1 of IEC 60601-1-8:2006 necessitated an additional configuration capability for
this ME EQUIPMENT . This capability is necessary when the RESPONSIBLE ORGANIZATION needs auditory
ALARM SIGNALS for LOW PRIORITY ALARM CONDITIONS such as for intensive care units when central monitoring is not
being used.

Table 208.101 modifies Table 1 – ALARM CONDITION priorities, for ME EQUIPMENT that includes
in its INTENDED USE monitoring of PATIENTS that are not continuously attended by a clinical
OPERATOR in NORMAL USE :

Table 208.101 – ALARM CONDITION priorities for ME EQUIPMENT that includes in its
INTENDED USE monitoring of PATIENTS that are not continuously
attended by a clinical OPERATOR
a
Potential result of failure Onset of potential HARM
to respond to the cause b c d
of ALARM CONDITION Immediate Prompt Delayed
e
Death or irreversible injury HIGH PRIORITY HIGH PRIORITY MEDIUM PRIORITY

Reversible injury HIGH PRIORITY MEDIUM PRIORITY LOW PRIORITY

Minor injury or discomfort MEDIUM PRIORITY LOW PRIORITY LOW PRIORITY

a
Onset of potential HARM refers to when an injury occurs and not to when it is manifested.
b
Having the potential for the event to develop within a period of time not usually sufficient for manual corrective
action.
c
Having the potential for the event to develop within a period of time usually sufficient for manual corrective
action.
d
Having the potential for the event to develop within an unspecified time greater than that given under “prompt”.
e
Where practicable, ME EQUIPMENT with a therapeutic function incorporates automatic safety mechanisms to
prevent immediate death or irreversible injury caused by the ME EQUIPMENT . See also appropriate particular
standards.

208.6.3.3 Auditory ALARM SIGNALS

208.6.3.3.1 * Characteristics of auditory ALARM SIGNALS

Addition:

For ME EQUIPMENT that includes in its INTENDED USE monitoring of PATIENTS that are not
continuously attended by a clinical OPERATOR in NORMAL USE :

– Auditory ALARM SIGNALS shall annunciate for LOW PRIORITY ALARM CONDITIONS (delete
footnote “d” from Table 3 of IEC 60601-1-8:2006).
– Replace “> 15 s or no repeat” with “2,5 s to 30,0 s” in the “ LOW PRIORITY ALARM SIGNAL ”
column of Table 3 of IEC 60601-1-8:2006.
– Auditory ALARM SIGNALS shall annunciate for TECHNICAL ALARM CONDITIONS .

Table 208.102 modifies Table 3 – Characteristics of the burst of auditory ALARM SIGNALS , for
ME EQUIPMENT that includes in its INTENDED USE monitoring of PATIENTS that are not
continuously attended by a clinical OPERATOR in NORMAL USE :
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Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS for

ME EQUIPMENT that includes in its INTENDED USE monitoring of PATIENTS
that are not continuously attended by a clinical OPERATOR

Characteristic HIGH PRIORITY MEDIUM PRIORITY LOW PRIORITY

ALARM SIGNAL ALARM SIGNAL ALARM SIGNAL

Number of PULSES in BURST a, e 10 3 1 or 2

P ULSE spacing (t s ) (see Table 208.101)
between 1 st and 2 nd PULSE x y y
between 2 nd and 3 rd PULSE x y Not applicable
rd th
between 3 and 4 PULSE 2x + t d Not applicable Not applicable
th th
between 4 and 5 PULSE x Not applicable Not applicable
th th
between 5 and 6 PULSE 0,35 s to 1,30 s Not applicable Not applicable
th th
between 6 and 7 PULSE x Not applicable Not applicable
between 7 th and 8 t h PULSE x Not applicable Not applicable
th th
between 8 and 9 PULSE 2x + t d Not applicable Not applicable
th th
between 9 and 10 PULSE x Not applicable Not applicable
I NTERBURST INTERVAL b, c (t b ) 2,5 s to 15,0 s 2,5 s to 30,0 s >15 s to 60 s
Difference in amplitude between any two PULSES Maximum 10 dB Maximum 10 dB Maximum 10 dB
Where x shall be a value between 50 ms and 125 ms.
Where y shall be a value between 125 ms and 250 ms.
The variation of x and y within a BURST shall be ± 5 %.
MEDIUM PRIORITY t d + y shall be greater than or equal to HIGH PRIORITY t d + x.
a
See also Table 4 of IEC 60601-1-8:2006 for characteristics of the PULSE .
b
Unless otherwise specified in a particular standard for a particular ME EQUIPMENT .
c
M ANUFACTURERS are encouraged to use the longest INTERBURST INTERVAL consistent with the RISK ANALYSIS .
Writers of particular standards are encouraged to consider the longest appropriate INTERBURST INTERVAL of
the auditory ALARM SIGNAL for the particular ALARM SYSTEM application. Long INTERBURST INTERVALS can under
certain conditions negatively affect the ability to correctly discern, in a timely manner, the source of the
ALARM CONDITION .
e
Unless inactivated by the clinical OPERATOR , MEDIUM PRIORITY and LOW PRIORITY auditory ALARM SIGNALS shall
complete at least one BURST , and HIGH PRIORITY auditory ALARM SIGNALS shall complete at least half of one
BURST .

The ACCOMPANYING DOCUMENTS shall describe how the RESPONSIBLE ORGANIZATION may enable
or disable auditory ALARM SIGNALS for LOW PRIORITY ALARM CONDITIONS and may restrict access
to control over the INTERBURST INTERVAL for all auditory ALARM SIGNALS . The requirements of
6.7 of IEC 60601-1-8:2006 apply.

NOTE This adaptation of Table 3 of IEC 60601-1-8:2006 necessitated an additional configuration capability for
this ME EQUIPMENT . This capability is necessary when the RESPONSIBLE ORGANIZATION needs auditory
ALARM SIGNALS for LOW PRIORITY ALARM CONDITIONS such as for intensive care units when central monitoring is not
being used.

R ISK MANAGEMENT shall be applied to determine the maximum INTERBURST INTERVAL for
auditory ALARM SIGNALS associated with HIGH , MEDIUM , and LOW PRIORITY ALARM CONDITIONS .

Compliance is checked by inspection of the RISK MANAGEMENT FILE .

208.6.3.3.2 Volume of auditory ALARM SIGNALS and INFORMATION SIGNALS

Addition:
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208.6.3.3.2.101 * Volume of auditory ALARM SIGNALS reducible to zero

If the clinical OPERATOR reduces the volume of auditory ALARM SIGNALS to zero (no sound
pressure), the ALARM SIGNAL ’ S inactivation state AUDIO OFF shall be indicated, unless
ME EQUIPMENT is part of a DISTRIBUTED ALARM SYSTEM where the ALARM SIGNALS are repeated
at remote components of a DISTRIBUTED ALARM SYSTEM.

Compliance is checked by functional test.

208.6.4.2 * Delays to or from a DISTRIBUTED ALARM SYSTEM

Addition:

The ALARM SIGNAL GENERATION DELAY of PHYSIOLOGICAL ALARM CONDITIONS and TECHNICAL
ALARM CONDITIONS at remote components of a DISTRIBUTED ALARM SYSTEM shall be limited so
that PATIENT treatment is not unacceptably delayed. R ISK MANAGEMENT shall be applied to
determine the maximum ALARM SIGNAL delay time that is acceptable before presentation of
ALARM SIGNALS at remote components of a DISTRIBUTED ALARM SYSTEM .

Compliance is checked by inspection of the RISK MANAGEMENT FILE .

208.6.6 ALARM LIMIT

208.6.6.2 Adjustable ALARM LIMIT

Addition:

208.6.6.2.101 Adjustment range of heart rate ALARM LIMITS

M E EQUIPMENT shall be equipped with means to adjust upper and lower heart rate
ALARM LIMITS . For adult PATIENTS , the upper ALARM LIMIT settings shall be adjustable to at least
between 100 1/min and 200 1/min and the lower ALARM LIMIT settings shall be adjustable at
least between 30 1/min and 100 1/min. For neonatal and paediatric PATIENTS , the upper
ALARM LIMIT settings shall be adjustable at least between 100 1/min and 250 1/min and the
lower ALARM LIMIT settings shall be adjustable at least between 30 1/min and 150 1/min.

Compliance is checked by inspection.

208.6.6.2.102 Resolution of ALARM LIMIT settings

The ALARM LIMIT settings shall be adjustable in steps not exceeding ±5 1/min.

Compliance is checked by inspection.

208.6.6.2.103 Time to alarm for heart rate ALARM CONDITIONS

The ALARM SIGNAL GENERATION DELAY for cardiac standstill (asystole) shall not exceed 10 s.

The sum of ALARM CONDITION DELAY and ALARM SIGNAL GENERATION DELAY for ALARM SIGNALS
for low heart rate or high heart rate ALARM CONDITIONS shall not exceed 10 s.

Compliance is checked by the following tests:

For all tests, a simulated ECG signal of 1 mV QRS amplitude and 70 ms QRS duration is
applied. The deviation of the input heart rate from the nominal value shall be less than 5 %.

Low heart rate ALARM CONDITION : Set the heart rate to 80 1/min and the lower ALARM LIMIT to
60 1/min. Change the heart rate in a step function manner from 80 1/min to 40 1/min.
BS EN 60601-2-27:2014
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Measure the time interval between the heart rate change and when the ALARM SIGNALS
indicate that low limit ALARM CONDITION .

High heart rate ALARM CONDITION : Set the heart rate to 80 1/min and the upper ALARM LIMIT to
100 1/min. Change the heart rate in a step function manner from 80 1/min to 120 1/min.
Measure the time interval between the heart rate change and when ALARM SIGNALS indicate
that high limit ALARM CONDITION .

Cardiac standstill: Set the heart rate to 80 1/min and the lower ALARM LIMIT to 60 1/min.
Change the heart rate in a step function manner from 80 1/min to 0 1/min. Measure the time
interval between the heart rate change and when ALARM SIGNALS indicate the cardiac standstill
ALARM CONDITION .

208.6.6.2.104 * T ECHNICAL ALARM CONDITION indicating inoperable ME EQUIPMENT

M E EQUIPMENT shall be provided with means to indicate within 10 s that the ME EQUIPMENT is
inoperable due to an overload or saturation of any part of the ECG amplifier and due to
disconnected ECG LEAD WIRES .

Compliance is checked by the following test using the test circuit of Figure 201.105.

Set the GAIN to 10 mm/mV and the sweep speed to 25 mm/s. Close switches S, S2 and set S4
in position B. Connect the signal generator between the R (RA) LEAD WIRE and all other
LEAD WIRES connected to the N (RL) LEAD WIRE . In series with the signal generator, connect a
d.c. power supply capable of providing a –5 V to +5 V output.

Adjust the signal generator to provide a 10 Hz signal. Apply a 10 Hz, 1 mV signal

superimposed on a d.c. voltage variable from –5 V to +5 V.

Starting from zero, increase the d.c. voltage at a rate of approximately 1 V/s in increments
from 0 V to +5 V and –5 V, using any deblocking facility of the ME EQUIPMENT to restore the
trace.

If the 10 Hz signal is not visible within 10 s, with an amplitude of at least 0,5 mV referred to
the input, verify that a TECHNICAL ALARM CONDITION indicates that the ME EQUIPMENT is
inoperable.

Disconnect all LEAD WIRES . Verify that within 10 s a TECHNICAL ALARM CONDITION indicates that
the ME EQUIPMENT is inoperable.

208.6.6.2.105 Assignment of ALARM CONDITION priority

A LARM SIGNALS of heart rate ALARM CONDITIONS shall be at least of MEDIUM PRIORITY . The
PHYSIOLOGICAL ALARM CONDITIONS cardiac standstill (asystole), ventricular tachycardia and
ventricular fibrillation shall be of HIGH PRIORITY . Priorities of other PHYSIOLOGICAL
ALARM CONDITIONS such as arrhythmias (VPCs, ventricular bigeminy or irregular HR etc.) or
whether those events may be treated as INFORMATION SIGNALS shall be determined by
RISK MANAGEMENT .

Compliance is checked by inspection and functional tests.

208.6.8 ALARM SIGNAL inactivation states

Addition:

208.6.8.101 * T ECHNICAL ALARM CONDITIONS

Inactivation of ALARM SIGNALS ( ALARM PAUSED , and ALARM OFF )

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a) shall not inactivate visual ALARM SIGNALS of TECHNICAL ALARM CONDITIONS that identify the
specific ALARM CONDITION and its priority at a distance of 1 m from the ME EQUIPMENT ;
b) may inactivate the visual ALARM SIGNAL specified in subclause 6.3.2.2 b) of IEC 60601-1-8.

In the case of a TECHNICAL ALARM CONDITION the any measured value(s) of the parameter(s)
shall be displayed in such a way that the validity of the measured value(s) can be identified by
the clinical OPERATOR .

NOTE During a TECHNICAL ALARM CONDITION , the physiological parameter(s) might not be capable of detecting
PHYSIOLOGICAL ALARM CONDITIONS .

If LEAD WIRES , PATIENT CABLE or modules are intentionally disconnected by the clinical
OPERATOR as specified by the MANUFACTURER , ALARM RESET may be used to disable the visual
ALARM SIGNAL of those TECHNICAL ALARM CONDITIONS . Such means shall be documented in the
instructions for use (see subclause 201.7.9.2.9.101 a) 14).

Compliance is checked by inspection and functional tests.

208.6.9 * ALARM RESET

Replacement:

Means shall be provided for the clinical OPERATOR to activate ALARM RESET of ALARM SIGNALS .

After activation of the ALARM RESET function

a) the auditory ALARM SIGNALS of PHYSIOLOGICAL ALARM CONDITIONS shall cease, enabling the
ALARM SYSTEM to respond to a subsequent ALARM CONDITION .

b) visual ALARM SIGNALS for LATCHING ALARM CONDITIONS that no longer exist shall cease (see
201.7.9.2.9.101 14) and 208.6.8.101)).
c) visual ALARM SIGNALS for any existing ALARM CONDITIONS shall continue as long as those
ALARM CONDITIONS exist.

d) the ALARM SYSTEM shall be enabled immediately so that it can respond to a subsequent
ALARM CONDITION .

e) the visual ALARM SIGNALS of TECHNICAL ALARM CONDITIONS shall not cease as long as the
technical ALARM CONDITION exists.

The means of control of ALARM RESET shall be marked with symbol IEC 60417-5309 (2002-10)
(see IEC 60601-1-8-2006 symbol 2 of Table C.1 and/or with the text string of marking 5 in
Table C.2.).

Compliance is checked by inspection.

208.6.10 * N ON - LATCHING and LATCHING ALARM SIGNALS

Addition to the first paragraph:

For ME EQUIPMENT that supports mixtures of LATCHING ALARM SIGNALS and NON -
LATCHING ALARM SIGNALS , means shall be provided that allows the RESPONSIBLE ORGANIZATION
to configure ME EQUIPMENT to have all LATCHING ALARM SIGNALS or all NON - LATCHING
ALARM SIGNALS for PHYSIOLOGICAL ALARM CONDITIONS and to restrict access to this configuration
to the RESPONSIBLE ORGANIZATION .

NOTE This requirement adds an additional configuration capability for use in intensive care units where the
RESPONSIBLE ORGANIZATION needs LATCHING ALARM SIGNALS for all ALARM CONDITIONS .

Compliance is checked by functional test

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Addition:

208.6.10.101 * N ON - LATCHING ALARM SIGNALS for TECHNICAL ALARM CONDITIONS

N ON - LATCHING ALARM SIGNALS shall be assigned to TECHNICAL ALARM CONDITIONS .

208.6.11 D ISTRIBUTED ALARM SYSTEM

208.6.11.2.2 * Failure of remote communication of ALARM CONDITIONS

Replacement of item b):

b) shall create a TECHNICAL ALARM CONDITION in any affected parts of the DISTRIBUTED ALARM
SYSTEM that can generate ALARM SIGNALS .

Addition:

If, while the ME EQUIPMENT is in the AUDIO OFF state, the ME EQUIPMENT detects a
communication failure with the DISTRIBUTED ALARM SYSTEM , it shall terminate the AUDIO OFF
state and shall initiate a TECHNICAL ALARM CONDITION .

Additional subclause:

208.6.11.101 * Inactivation/activation of ALARM SIGNALS at remote components of a

DISTRIBUTED ALARM SYSTEM

If deemed acceptable by RISK MANAGEMENT for its intended environment of use, ME EQUIPMENT
may be provided with means for the clinical OPERATOR to activate and inactivate
ALARM SIGNALS of the ME EQUIPMENT or to change ALARM LIMIT SETTINGS from remote
components of a DISTRIBUTED ALARM SYSTEM by:

– enabling any inactivation states that are configured on the ME EQUIPMENT ( ALARM PAUSED ,
AUDIO PAUSED , ALARM OFF or AUDIO OFF ) and activating the function ALARM RESET and

– termination of the inactivation state.

M E EQUIPMENT that provides means to remotely activate and inactivate ALARM SIGNALS shall
also provide means to configure (enable or disable) remote inactivation/activation for every
provided inactivation state. To prevent the clinical OPERATOR from changing that configuration,
such means shall be restricted to the RESPONSIBLE ORGANIZATION (see 6.7 of IEC 60601-1-
8:2006).

Compliance is checked by inspection.

Annexes

The annexes of the general standard apply.

 BS EN 60601-2-27:2014
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Annex AA
(informative)

Particular guidance and rationale

AA.1 Use with defibrillator

This category of ME EQUIPMENT is likely to be used in the intensive monitoring of the critically
ill and particularly in coronary care units, environments in which the use of defibrillators is to
be expected.

Defibrillator protection is required not only from the safety point of view but also, as this
ME EQUIPMENT gives the first indication of the restoration of sinus rhythm, from the
performance point of view (see 201.8.5.5.1).

The Working Group was thus in no doubt that not only must defibrillator protection be made a
requirement in this ME EQUIPMENT , but that the ME EQUIPMENT also shall show a reasonable
trace within a short time to indicate to the clinician or user the outcome of the defibrillation
action. Subclause 201.8.5.5.1 calls for a visible trace within 5 s of the defibrillation action and
this requirement includes the recovery of the ELECTRODES .

AA.2 Rationale for defibrillator test voltages

AA.2.1 General

When a defibrillation voltage is applied to the thorax of a PATIENT via externally applied
paddles, the body tissue of the PATIENT in the vicinity of the paddles and between them
becomes a voltage dividing system.

The voltage distribution can be gauged roughly using three-dimensional field theory but is
modified by local tissue conductivity, which is far from uniform.

If the ELECTRODE of an item of ME EQUIPMENT is applied to the thorax or trunk of this PATIENT ,
roughly within the compass of the defibrillator paddles, the voltage to which such an
ELECTRODE is subjected depends on its position but will generally be less than the on-load
defibrillator voltage. Unfortunately, it is not possible to say how much less, as the ELECTRODE
in question may be placed anywhere in this area, including immediately adjacent to one of the
defibrillator paddles. For safety, it must therefore be required that such an ELECTRODE and the
ME EQUIPMENT to which it is connected shall be able to withstand the full defibrillator voltage.
This must be the no-load voltage, as one of the defibrillator paddles may not be making good
contact with the PATIENT .

Only in special cases where the ELECTRODES are known with certainty to be placed either
almost exactly between the defibrillator paddles (such as oesophageal ELECTRODES ), or
effectively electrically between them but at a remote point on the PATIENT (such as EEG or
urological ELECTRODES ), can it be safely assumed that the voltage applied to the ELECTRODES
will be less than the voltage of the defibrillator. In such cases, a safe requirement for the
ELECTRODES and the ME EQUIPMENT to which they are connected is that they are able to
withstand somewhat over half the no-load voltage of the defibrillator.

The last set of circumstances to be considered is when the ELECTRODE is connected to the
PATIENT outside the compass of the defibrillator paddles, such as on the PATIENT ' S arm or
shoulder. The only safe assumption here is that no voltage-dividing effect takes place, and
the arm or shoulder effectively becomes an open-ended electrical conductor connected to the
nearer defibrillator paddle. The ELECTRODE and associated ME EQUIPMENT have to be able to
withstand the full no-load voltage of the defibrillator.
BS EN 60601-2-27:2014
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In this discussion, as in the requirements of this particular standard, it is assumed that one of
the defibrillator paddles is connected to earth.

AA.2.2 Summary

Table AA.1 lists typical examples of electrode positions and resulting voltages that may
develop between these electrodes during a defibrillator discharge. Under worst case
conditions the full no-load defibrillator voltage is applied between ELECTRODES .

Table AA.1 – Electrode positions and electrical strength requirements

Electrode position Electrical strength requirement

On or in thorax, exact position indeterminate Full no-load defibrillator voltage: 5 kV

On or in thorax or remote from it, but predictably Somewhat over half no-load defibrillator voltage: 3 kV
electrically midway between defibrillator paddles
Remote from thorax, not electrically midway between Full no-load defibrillator voltage: 5 kV
defibrillator paddles

AA.2.3 Specific requirement

For this particular standard, the first and the third conditions from Table AA.1 apply.
Monitoring ELECTRODES are usually placed on the PATIENT ' S chest, shoulders or back but may
also be placed on the patient's limbs. The ME EQUIPMENT therefore is subjected to a test
voltage of 5 kV.

AA.3 Guidance and rationale for particular clauses

Several clauses from the second edition of IEC 60601-2-27 were eliminated because those
clauses were incorporated in IEC 60601-1:2005.

Subclause 201.1.1 – Scope

The scope of this particular standard is defined as to include ME EQUIPMENT most commonly
used for acquiring data from the PATIENT ' S body.

Subclause 201.5.8 – Sequence of tests

Tests of 8.5.5 are performed first so that the tests of LEAKAGE CURRENT and dielectric strength
may show any DEGRADATION in the protective means. Tests of 201.12.1.101.16 b),
201.12.1.101.7 and 201.12.1.101.9 are performed before the tests for the remaining
subclauses of 201.12.1.101 to identify the vertical conversion factor determined in
201.12.1.101.7 needed for many of those tests.

Subclause 201.6.2 – Protection against electric shock

M E EQUIPMENT may be used in intracardiac procedures. Additionally, ME EQUIPMENT is

frequently part of MULTIFUNCTION PATIENT MONITORING EQUIPMENT in which some or many other
medical devices are connected to the same patient ( ME SYSTEM). Therefore, reference to
TYPE B and TYPE BF APPLIED PARTS is deleted.

Subclause 201.7.9.2.9.101 a) 4) – Additional instructions for use

The MANUFACTURER should describe the need to pay special attention to the type of
ELECTRODES used, since some ELECTRODES may be subject to large offset potentials due to
polarization. Recovery time after application of defibrillator pulses may be especially
compromised. Squeeze bulb electrodes commonly used for diagnostic ECG recording may be
 BS EN 60601-2-27:2014
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particularly vulnerable to this effect. Also, a clear warning should provided that ELECTRODES
of dissimilar metals should not be used unless the ELECTROCARDIOGRAPHIC MONITORING
EQUIPMENT can handle polarization potentials as high as 1 Volt (V).

Subclause 201.7.9.2.9.101 a) 7) – Additional instructions for use

This requirement covers both frequent (daily) checks by the clinical OPERATOR as well as less
frequent, but more comprehensive technical checks to detect mechanical damage and
damage to cables etc.

Subclause 201.8.5.2.3 – P ATIENT leads

This requirement guards against two HAZARDOUS SITUATIONS : Firstly there shall be no
possibility of an accidental PATIENT -to-earth connection via any LEAD WIRES , which may
become detached from an ELECTRODE . Secondly there shall be no possibility of connecting the
PATIENT accidentally to any live parts or hazardous voltages.

This means that for all ME EQUIPMENT , LEAD WIRES having exposed metal pin connectors, such
as banana plugs, are not permissible. To meet the requirements of this particular standard,
the connectors on LEAD WIRES that connect to ELECTRODES shall have no exposed conductive
parts or conductive parts that could contact earth. This requirement is fulfilled if the air
clearance between connector pins and a flat surface is at least 0,5 mm. The minimum
necessary air clearance of 0,5 mm ensures a reliable contact with ELECTRODES . This
requirement does not apply to the ELECTRODES themselves.

For all other connectors of a PATIENT CONNECTION – except that part of the LEAD WIRES that is
connected to an ELECTRODE – the requirements of 8.5.2.3 of the general standard apply.

Figure AA.1 illustrates the requirements and rationale of 201.8.5.2.3.

EQUIPMENT PATIENT CONNECTIONS

LEAD WIRES

APPLIED PART

1) 2) 3) 4)
0,5 mm min
air clearance
IEC 626/11
Key
Conductive connection to the PATIENT illustrating 8.5.2.3 of the general standard: connectors remote
to the PATIENT
Conductive connection to the PATIENT illustrating 201.8.5.2.3: connectors remote to the
ME EQUIPMENT

Items 1 to 4 illustrate conductive connections to and from the PATIENT . Without protective means,
disconnected conductive connections may earth the PATIENT .
conductive connection to a PATIENT (8.5.2.3 of the general standard) - 1 mm/1 500 V if the connector
1), 3)
is able to be plugged into a mains socket
PATIENT -to-earth connection via the APPLIED PART (addition 201.8.5.2.3 of this particular standard) –
2), 4)
0,5 mm air clearance

Figure AA.1 – APPLIED PART with multiple PATIENT CONNECTIONS

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Subclause 201.8.5.5.1 – Defibrillation protection

To determine whether an attempt to defibrillate a PATIENT was successful, the ME EQUIPMENT

needs to quickly recover from the amplifier overload produced by the defibrillation pulse. A 5 s
recovery time is considered to be satisfactory to verify the effectiveness of the defibrillation.

The 400 Ω current-limiting resistor in test circuit of Figure 11 in the general standard
represents the resistance of body tissue between one defibrillator paddle and an ELECTRODE .
This value was used since it is unlikely that both defibrillator ELECTRODES will contact
ELECTRODES of the ME EQUIPMENT at the same time.

The switching period of 200 ms is not critical, to the extent that "very briefly" would almost be
an adequate replacement, but quoting a time gives an indication of scale.

At the time of defibrillation, many different LEAD combinations may be in use, potentially
exposing any of those LEADS to the defibrillation voltage. Therefore, the LEAD combinations
shown in Table 201.103 must be tested. These combinations ensure that every ELECTRODE is
tested and include the LEAD ( S ) most likely to be affected by the ELECTRODE ( S ) connected to
point C.

With certain types of ELECTRODES , the discharge of a defibrillator through a PATIENT may
produce large d.c. offset potentials that might disable the amplifier of the ME EQUIPMENT . While
the display may appear to recover, the ECG amplifier may remain inoperative for some time.
(The requirement of 208.6.6.2.104 draws attention to such a situation.). The apparent lack of
cardiac activity could lead to incorrect treatment. This can be minimised by a suitable choice
of ELECTRODES (see also AA.1 and AA.2).

Subclause 201.11.6.5 – Ingress of water or particulate matter into ME EQUIPMENT and

ME SYSTEMS

Small-sized ME EQUIPMENT or smaller parts of ME EQUIPMENT may be mounted on IV poles or

used close to the PATIENT . Such use close to the PATIENT makes it likely that the
ME EQUIPMENT may accidentally get wet during NORMAL USE . After being wetted in NORMAL USE ,
the ME EQUIPMENT needs to continue to provide BASIC SAFETY and ESSENTIAL PERFORMANCE to
continue monitoring the PATIENT .

Subclause 201.11.8 – Interruption of the power supply/ SUPPLY MAINS to the ME EQUIPMENT

Interruptions of the SUPPLY MAINS for less than 30 s are mainly caused by switching to an
emergency power supply. Such power interruptions are considered NORMAL USE and
consequently should not result in HAZARDS to the PATIENT . When power returns, the
ME EQUIPMENT needs to resume the same mode of operation and restore all OPERATOR
settings and PATIENT data that were in use before the SUPPLY MAINS was interrupted.
Examples of typical stored data that may impact PATIENT safety are operating mode,
ALARM SETTINGS (volume of auditory ALARM SIGNAL , ALARM LIMITS , ALARM OFF , etc.), trend data,
and pacemaker pulse rejection, if OPERATOR selectable. In contrast to these settings, the
instantaneous heart rate or the displayed ECG waveform do not fall under stored data.

Subclause 201.11.8.101 – Protection against depletion of battery

A discharged battery may be simulated using a laboratory variable power supply set to a low
voltage and a series impedance to represent the increased battery impedance normally found
under these circumstances. The value of series impedance should be found by experiment.
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Subclause 201.12.1.101 – E SSENTIAL PERFORMANCE of ME EQUIPMENT

More than 25 years ago, the Association for the Advancement of Medical Instrumentation
(AAMI) published EC13, the first standard that included safety and performance requirements
for ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT . At that time, all ELECTROCARDIOGRAPHIC
MONITORING EQUIPMENT were wall-mounted and had built-in displays. These two characteristics
fundamentally affected several key performance requirements relating to how ECG waveforms
were displayed.

ANSI/AAMI EC13 was substantially revised in both 1992 and 2002. The 1992 revision added
several new performance requirements. The 2002 revision changed the EMC requirements,
added tests for electrosurgical interference and clarified several other test methods. These
revisions did not affect those display-related requirements.

The first edition of IEC 60601-2-27, which was published in 1994, focused on safety related
requirements for ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT . The second edition of
IEC 60601-2-27, which was published in 2005, added requirements related to
ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT . Many
ESSENTIAL PERFORMANCE requirements of the second edition of IEC 60601-2-27 became
harmonized with ANSI/AAMI EC13:2002.

Some of the presentation-related requirements that originated in the first edition of

ANSI/AAMI EC13 have changed. For example, the requirement for a 30 mm channel height
ensures that an ECG waveform is large enough to be seen from the foot of the PATIENT ’ S bed.
Two major changes to market needs have made it increasingly difficult for
ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT to meet the requirements of the IEC 60601-2-
27 and ANSI/AAMI EC13:2002:

– Many RESPONSIBLE ORGANIZATIONS now require a display size to meet their specific needs.
Such ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT works with any size display rather
than with a single built-in display.
– Surface-mount technologies allow networked ELECTROCARDIOGRAPHIC MONITORING
EQUIPMENT to be worn by a PATIENT [a clinical OPERATOR only views the display while he is
physically with the PATIENT (e.g., viewing distance from < 1 m].

These requirements have changed because earlier editions of both standards for
ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT treated the requirements for GAIN , sweep
speed and waveform aspect ratio equally. The ECG waveform’s aspect ratio is the most
clinically important of the three. In this edition of IEC 60601-2-27, requirements and tests
related to waveform presentation were updated to account for the importance of aspect ratio,
thereby addressing these market changes.

The revised sweep speed accuracy test of 201.12.1.101.7 verifies that the sweep speed of the
ME EQUIPMENT is suitable for any NON - PERMANENT DISPLAY . The vertical conversion factor
identified in that clause is used to determine whether the GAIN and aspect ratio of the
ME EQUIPMENT are clinically acceptable.

Note that the Working Group felt that disclosure of the waveform height on the original display
was not necessary, because another subclause requires a GAIN INDICATOR (see
201.12.1.101.9). This standard requires devices to provide a GAIN setting of 10 mm/mV. The
accuracy of that setting is easily determined because the waveform GAIN is linearly
proportional depending upon the vertical conversion factor determined in 201.12.1.101.7 that
is applied.

Subclause 201.12.1.101.2 – Input dynamic range and differential offset voltage

M E EQUIPMENT must function properly in the presence of skin-to-electrode voltages that are
known to be present.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 59 –

Subclause 201.12.1.101.3 – Input impedance

This test assures an input impedance of at least 2,5 MΩ. This is necessary in order to avoid
excessive loss of signal amplitude due to high skin impedances.

Subclause 201.12.1.101.8 – Frequency and impulse response

Most new ME EQUIPMENT uses digital signal processing which may make it difficult to
determine the high frequency response using analogue sinusoidal signals. The sampling
frequency chosen, based upon circuit design considerations, may be too low for accurate
reproduction of sine wave signals. For this reason, ME EQUIPMENT has to comply with both
methods A and B.

An isosceles triangular waveform simulates an ECG signal more closely than a sine wave. The
high frequency response of the ME EQUIPMENT is reasonably determined by a single pole low
pass filter. The loss of amplitude of the isosceles triangular waveform when using a low pass
filter can be shown to be 20/Wf c or 50T R /W where W is the base width of the triangle, f c is the
corner frequency and T R is the rise time of the low pass filter.

A loss in amplitude of 25 % corresponds to a high frequency response of 40 Hz when the

base width of the triangular input is 20 ms. The high-frequency response limit of 40 Hz is
based on two considerations. First, the primary purpose for monitoring ECG , heart rate
determination, is adequately accomplished without a higher frequency response. Second, the
persistent problem of high-frequency NOISE from power line frequencies and from muscle
artefact is reduced by a 40 Hz bandwidth.

The low frequency response was previously stated in terms of a low cut-off frequency of
0,05 Hz, which was sufficient to achieve accurate ST-segment reproduction even for a first-
order filter with unspecified phase response. More sophisticated filters are now commonly
used which achieve equally accurate reproduction of ST-segment level, and adequate slope
reproduction, even though the filters have a higher cut-off frequency and thus enable faster
baseline recovery. Hence, based on the AHA 1990 recommendations, low frequency response
requirements are now stated in terms of impulse response requirements. The requirements
specified in 201.12.1.101.8 are sufficient to ensure adequate ST-segment reproduction.

Subclause 201.12.1.101.10 – Common mode rejection

M E EQUIPMENT must reject some degree of the mains frequency voltages that capacitively
couple to the PATIENT . The source capacitance of 200 pF that is achieved in the test,
simulates the impedance of the PATIENT to earth.

In order to check the COMMON MODE REJECTION of the ME EQUIPMENT ’s circuit, it is necessary to
disable any SUPPLY MAINS frequency notch filter. Otherwise, this test mostly checks the
(differential mode) rejection of such a notch filter. It is desirable to achieve good COMMON
MODE REJECTION at frequencies other than the SUPPLY MAINS frequency. Some modern
ME EQUIPMENT has notch filters permanently on, i.e., they are not switchable (e.g., the line
filter may always be on). Notwithstanding, the test of 201.12.1.101.10 must be done with all
line filters disabled, even if it requires a special version of software and hardware to do so.

Subclause 201.12.1.101.12 – Pacemaker pulse display capability

The capability of displaying pacemaker pulses informs the clinical OPERATOR about the proper
functioning of a pacemaker. Ideally, these pulses could be shown as a small spike or needle.
In reality, the repolarisation tail of a pacemaker pulse may fall within the same frequency
band as QRS complex and may distort the ECG . A difference in baseline position prior to and
after the pacemaker pulse keeps the distortion at a minimum.
 BS EN 60601-2-27:2014
– 60 – 60601-2-27  IEC:2011

Subclause 201.12.1.101.15 – Heart rate range, accuracy, and QRS detection range

The performance requirements for the heart rate meter in cases where the rate of the input
signal is outside the measurement range stem from concerns about reported instances of
falsely low readings in the presence of extremely high rates. Treatable tachycardias at rates
up to 300 1/min occur in neonatal/paediatric and adolescent PATIENTS (Venugopalan 4) , et al.,
2002). Such PATIENTS must be protected from falsely low heart rate readings and consequent
failures to alarm.

Subclause 201.12.1.101.16 – Channel height and aspect ratio

E CG waveforms must be clearly visible from the disclosed intended viewing position. The
usability process standards address this need even though this is not directly testable.

Channel height and waveform aspect ratio are fundamental characteristics of any visual
presentation of an ECG waveform.

Earlier standards used the term “channel width” rather than “channel height”. While making
technical changes related to the inadvertent linkage of the GAIN , sweep speed, and aspect
ratio requirements in earlier standards, the committee chose to also correct this issue at the
same time.

NOTE The original term “channel width” relates to how ECG waveforms are printed on strip recordings. If a strip
recording is viewed while the ECG waveform is being printed, the amplitude of the QRS complex extends from left
to right on the paper. Writers of earlier standards, therefore, used the term “channel width” to describe this.
Considering instead how an ECG waveform appears on a screen, however, leads one to realize that “channel
height” is more understandable.

The INTENDED USE / INTENDED PURPOSE of ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT

ultimately determines its channel height. For example, the INTENDED USE / INTENDED PURPOSE of
wall-mounted ME EQUIPMENT and PATIENT -worn ME EQUIPMENT both require the ECG waveform
to be clearly visible from the intended viewing position, but these products implement this
requirement differently because their intended viewing positions are different.

– A channel height ≥ 30 mm for a wall-mounted monitor ensures the waveform is visible

from 5 – 8 m.
– A channel height of 10 mm is sufficient for a PATIENT -worn monitor that presents
3 waveforms on a display that is 60 mm vertically (because the clinical OPERATOR views it
from 1 – 2 m versus 8 m).

Subclause 201.15.3.4.101 – E LECTRODES and PATIENT CABLES

Future development in ELECTRODES cannot be predicted but there is a possibility that they
may contain a small amplifying device.

Subclause 202.6.2.6.1 bb) – Requirements

Due to the sensitivity of this type of ME EQUIPMENT it is not reasonable to expect the
ME EQUIPMENT will be used in an environment where interference of such level will be induced.

—————————
4) Venugopalan, P. et al. Superventricular tachycardia in children: a report of three cases, diagnosis and current
management. Third GCC Conference of Faculties of Medicine on Medical Education, Sultan Qaboos University,
Muscat, December 16-18, 2002.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 61 –

Subclause 202.6.2.101 – Electrosurgery interference

There is no ideal test method to generate electrosurgical interference in a test laboratory but
the one given in Figures 202.103 and 202.104 has been shown by experience to reproducibly
give results similar to those seen in surgical practice. The test should be done in the normal
working range of the HF SURGICAL EQUIPMENT (load approximately 500 Ω).

Disturbances caused by HF SURGICAL EQUIPMENT are considered NORMAL USE and

consequently should not result in HAZARDS to the PATIENT . Therefore, after an appropriate
recovery time the ME EQUIPMENT should resume normal operation without loss of stored data.
Examples of typical stored data that may impact PATIENT safety are operating mode,
ALARM SETTINGS (volume of auditory ALARM SIGNAL , ALARM LIMITS , ALARM OFF , etc.), and
pacemaker pulse rejection if OPERATOR selectable. In contrast to these settings, the
instantaneous heart rate or the displayed ECG waveform do not fall under stored data.

The most critical test is the application of a common-mode HF voltage as shown in Figure
202.103. Capacitive coupling of HF to functional earth may cause the ME EQUIPMENT to fail to
recover within the specified time if at all. For this reason it is not necessary to perform this
test with a differential-mode HF voltage.

E CG telemetry systems are not used in operating theatres. Requiring protection against the
effects of electrosurgery would unnecessarily burden such ME EQUIPMENT . Therefore, ECG
telemetry systems are excluded from this test.

Subclause 208.6.1.2 – ALARM CONDITION priority

The intersection of the ‘Delayed’ column and the ‘Minor injury or discomfort’ row in Table 1 of
IEC 60601-1-8:2006 contains ‘ LOW PRIORITY or no ALARM SIGNAL ’. Selection of ‘no
ALARM SIGNAL ’ may be appropriate for these ALARM CONDITIONS in environments of use where a
clinical OPERATOR continuously attends the PATIENT during NORMAL USE .

Such a selection is inappropriate for ME EQUIPMENT that is not continuously attended during
NORMAL USE since failure to provide an auditory ALARM SIGNAL effectively means that the
ALARM SYSTEM is disabled for those ALARM CONDITIONS .

Subclause 208.6.3.3.1 – Characteristics of auditory ALARM SIGNALS

An auditory ALARM SIGNAL that only occurs once (or does not occur, per Table 1 of IEC 60601-
1-8:2006) may be appropriate for a LOW PRIORITY ALARM CONDITION in environments of use
where the PATIENT is continuously attended by a clinical OPERATOR in NORMAL USE .

Such a selection is inappropriate for ME EQUIPMENT that is not continuously attended during
NORMAL USE since not repeating the auditory ALARM SIGNALS means that the ALARM CONDITION
is not likely to be recognized.

Subclause 208.6.3.3.2.101 – Volume of auditory ALARM SIGNALS reducible to zero

The primary alarm indicator that draws the attention to a clinical OPERATOR is the auditory
ALARM SIGNAL – especially for ME EQUIPMENT that includes in its INTENDED USE / INTENDED
PURPOSE monitoring of PATIENTS that are not continuously attended by a clinical OPERATOR .
Typical environments of use where PATIENTS are not continuously attended by health care
professionals are intensive care units (ICU). Normally, a clinical OPERATOR is caring for
several PATIENTS . Therefore, it is not possible to observe all PATIENT monitors at the same
time to be aware of all visual ALARM SIGNALS that are not associated with auditory
ALARM SIGNALS . In such an environment, reducing the volume of the auditory ALARM SIGNAL to
zero means that the ALARM SYSTEM enters the inactivation state AUDIO OFF that must be
indicated.
 BS EN 60601-2-27:2014
– 62 – 60601-2-27  IEC:2011

In such environments it is recommended to limit the adjustable volume of the auditory

ALARM SIGNAL to a minimum sound pressure.

In a DISTRIBUTED ALARM SYSTEM where remote components of a DISTRIBUTED ALARM SYSTEM

annunciate the ALARM SIGNALS the volume of the auditory ALARM SIGNAL may be reduced to
zero (no sound pressure) depending on the use model (see second paragraph of rationale
208.6.4.2).

Subclause 208.6.4.2 – Delays to or from a DISTRIBUTED ALARM SYSTEM

Alarm generating ME EQUIPMENT annunciates ALARM SIGNALS in response to ALARM CONDITIONS

that it detects. If this ME EQUIPMENT is part of a DISTRIBUTED ALARM SYSTEM, the DISTRIBUTED
ALARM SYSTEM may annunciate the ALARM SIGNALS of that ALARM CONDITION at remote
components of the DISTRIBUTED ALARM SYSTEM . It takes a finite amount of time for information
related to an ALARM CONDITION to reach all components of a DISTRIBUTED ALARM SYSTEM . In
many cases, this amount of time is very short, however, specific characteristics of a
DISTRIBUTED ALARM SYSTEM can significantly delay annunciation of ALARM SIGNALS at remote
components of the DISTRIBUTED ALARM SYSTEM .

Use models in intensive care units may require that remote equipment is operated as the
primary alarming equipment (e.g. when the alarm generating ME EQUIPMENT is configured with
the volume of its auditory ALARM SIGNAL reduced to zero – no sound pressure). In such an
environment of use the overall delay time before remote components of a DISTRIBUTED ALARM
SYSTEM annunciate ALARM SIGNALS should be limited to values that allow the clinician to
respond to PHYSIOLOGICAL ALARM CONDITIONS (such as cardiac arrest, ventricular fibrillation,
high systolic pressure, etc.) in time.

Inappropriate delay times for ALARM SIGNALS in a DISTRIBUTED ALARM SYSTEM may delay
treatment of PATIENTS . Therefore, it is strongly recommended that RISK MANAGEMENT be
applied to identify adequate ‘not to exceed’ delay times of ALARM SIGNALS to remote
components of a DISTRIBUTED ALARM SYSTEM.

Subclause 208.6.6.2.104 – T ECHNICAL ALARM CONDITION indicating inoperable

ME EQUIPMENT

M E EQUIPMENT that is inoperable should indicate this state on or adjacent to the display. This
may be fulfilled by the absence of a visible trace.

Subclause 208.6.8.101 – T ECHNICAL ALARM CONDITIONS

The alarm inactivation states ALARM OFF and ALARM PAUSED support the functionality that is
essential for PATIENT monitoring equipment: in both alarm inactivation states ( ALARM OFF and
ALARM PAUSED ), it is necessary for ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT that visual
ALARM SIGNALS of TECHNICAL ALARMS CONDITIONS are displayed. The purpose of these visual
ALARM SIGNALS is to inform the clinical OPERATOR – even during the alarm inactivation states
ALARM OFF or ALARM PAUSED – that the ME EQUIPMENT (or a part of the ME EQUIPMENT ) is not
operating because a TECHNICAL ALARM CONDITION such as ‘ ECG leads-off’ interrupts the ECG
monitoring of a PATIENT .

A TECHNICAL ALARM CONDITION may influence the validity of a measured value. For instance,
the TECHNICAL ALARM CONDITION ‘ ECG leads-off’ prevents the heart rate from being calculated
and displayed. Continuing to display the previously calculated heart rate may lead to
misinterpretations by the clinical OPERATOR because this value is invalid during the TECHNICAL
ALARM CONDITION . Appropriate means to indicate that the heart rate is invalid might be to
display a blank heart rate value or a symbol where the heart rate is displayed.

In other cases, the tolerance of the measured values might be influenced or the measurement
might be unreliable. In those cases, the clinical OPERATOR should be informed that the
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 63 –

currently displayed value might be questionable. The displayed value should be marked
accordingly.

Subclause 208.6.9 – ALARM RESET

The clinical OPERATOR action ALARM RESET performs the following actions: First, it stops the
auditory ALARM SIGNAL . Second, it stops visual LATCHING ALARM SIGNALS of ALARM CONDITIONS
that no longer exist. Third, it does not affect visual ALARM SIGNALS for ALARM CONDITIONS that
continue to exist (those signals continue until the ALARM CONDITIONS ceases). Fourth, it
enables the ALARM SYSTEM immediately to respond to a subsequent ALARM CONDITION . The
fourth action ‘enabling the ALARM SYSTEM immediately’ distinguishes the function ALARM RESET
from the alarm inactivation states ALARM PAUSED , AUDIO PAUSED , ALARM OFF and AUDIO OFF .

In contrast to the alarm inactivation states ALARM PAUSED , AUDIO PAUSED , ALARM OFF and
AUDIO OFF that temporarily or permanently disable the ALARM SYSTEM of ME EQUIPMENT , the
function (clinical OPERATOR action) ALARM RESET maintains the ALARM SYSTEM in the ‘ON’-state
but applies the functions that are specified in subclause 208.6.9 a) to e). This function stops
the auditory ALARM SIGNALS , controls the visual ALARM SIGNALS depending on an existing or
ceased ALARM CONDITION , and – as outlined before – keeps the ALARM SYSTEM enabled. As a
result, the ALARM SYSTEM can respond immediately to a subsequent ALARM CONDITION without
requiring additional clinical OPERATOR actions to activate the ALARM SYSTEM again. This also
explains why AUDIO PAUSED is not the appropriate state because it does not allow the related
control to perform these functions of ALARM RESET .

With the function ALARM RESET the clinical OPERATOR acknowledges an active
ALARM CONDITION once and does not need to be concerned about activating the ALARM SYSTEM
again because the ALARM SYSTEM remains in the ‘ON’-state. As a result, the function
ALARM RESET avoids the possibility that the clinical OPERATOR might forget to activate the
ALARM SYSTEM again.

Subclause 208.6.10 – N ON - LATCHING and LATCHING ALARM SIGNALS

Different use models exist for ME EQUIPMENT that 1) is continually attended by a clinical
OPERATOR (such as in operating theatres/rooms) and 2) is not continually attended by a
clinical OPERATOR (such as in an ICU). In environments of use such as an ICU or emergency
department, where PATIENTS are not continuously attended, a clinical OPERATOR normally
cares for several PATIENTS .

Clinical OPERATORS who are caring for several PATIENTS cannot observe all of their PATIENTS at
the same time. Clinical OPERATORS cannot easily identify short ALARM CONDITIONS that occur
on ME EQUIPMENT that provides NON - LATCHING ALARM SIGNALS or for mixes of NON - LATCHING
and LATCHING ALARM SIGNALS . This inability to identify and quickly respond to important short
ALARM CONDITIONS (e.g., short tachycardias) puts PATIENTS in HAZARDOUS SITUATIONS .

Configuring ME EQUIPMENT to only provide LATCHING ALARM SIGNALS forces clinical OPERATORS
to respond to every ALARM CONDITION . While this is conceptually a good idea, frequent false
ALARM CONDITIONS due to artefact or improperly set ALARM LIMITS can place a substantial
administrative burden on the clinical OPERATOR .

L ATCHING ALARM SIGNALS may be desirable within DISTRIBUTED ALARM SYSTEMS where remote
equipment of an ME SYSTEM is not continuously attended by a clinical OPERATOR . N ON -
LATCHING ALARM SIGNALS may be desirable in an environment of use where the ME EQUIPMENT
is continuously attended by a clinical OPERATOR .
 BS EN 60601-2-27:2014
– 64 – 60601-2-27  IEC:2011

Subclause 208.6.10.101 – N ON - LATCHING ALARM SIGNALS for TECHNICAL ALARM CONDITIONS

A TECHNICAL ALARM CONDITION indicates that a physiological measurement is not ready or has
been interrupted for technical reasons. Such technical interruptions of a measurement may be
caused by an unintentional disconnection of a TRANSDUCER or a LEAD WIRE . For instance, the
TECHNICAL ALARM CONDITION ’ ECG leads-off’ prevents the heart rate from being calculated and
displayed. This implies that the heart rate is not being monitored and as consequence
potential ALARM CONDITIONS may not be indicated. Requiring NON - LATCHING ALARM SIGNALS for
TECHNICAL ALARM CONDITIONS means those ALARM SIGNALS are displayed as long as the ALARM
CONDITION exists and cease without clinical OPERATOR interaction when the TECHNICAL ALARM
CONDITION is corrected.

Subclause 208.6.11.2.2 – Failure of remote communication of ALARM CONDITIONS

M E EQUIPMENT as part of a DISTRIBUTED ALARM SYSTEM is essential for reliable alarming in an

unattended environment of use. For that reason ME EQUIPMENT that falls under the scope of
this particular standard has to be so designed that it detects a communication failure and
indicates the ALARM SIGNALS of the corresponding TECHNICAL ALARM CONDITION . Labelling of
such an ME EQUIPMENT with a warning to the effect that it shall not be relied upon for receipt of
ALARM SIGNALS is not appropriate to mitigate the RISK of critically ill PATIENTS they are exposed
to.

The revised requirement 208.6.11.2.2 b) does only apply for ME EQUIPMENT that falls under the
scope of this particular standard. The same applies of the entire content of this particular
standard. Other components or parts of a DISTRIBUTED ALARM SYSTEM such as handheld
devices, paging systems or even cellular phones do not fall under the scope of this particular
standard; for those devices IEC 60601-1-8 applies.

Subclauses 208.6.11.101 – Inactivation/activation of ALARM SIGNALS at remote

components of a DISTRIBUTED ALARM SYSTEM

D ISTRIBUTED ALARM SYSTEMS duplicate ALARM SIGNALS at remote components of a DISTRIBUTED

ALARM SYSTEM such as a central station. Depending on the use model where the remote
components of a DISTRIBUTED ALARM SYSTEM are being actively used it makes sense to
activate/terminate the inactivation state ALARM PAUSED , AUDIO PAUSED , ALARM OFF or AUDIO OFF
(depending on the configuration) and to activate ALARM RESET at remote components of a
DISTRIBUTED ALARM SYSTEM . As indicated before, this remote control functionality depends on
the use model in certain environments of use such as in intensive care units. For this reason,
only the RESPONSIBLE ORGANIZATION should have access to the corresponding configuration.
The configuration that enables the function of remote activation and termination of global
inactivation states ( ALARM PAUSED , AUDIO PAUSED , ALARM OFF or AUDIO OFF ) and remote
activation of ALARM RESET must be protected. ‘Protected’ means that the clinical OPERATOR of
the ME EQUIPMENT must not have access in NORMAL USE to the selection of the capability to
activate and terminate global inactivation states ( ALARM PAUSED , AUDIO PAUSED , ALARM OFF or
AUDIO OFF ) and activation of ALARM RESET at remote components of a DISTRIBUTED ALARM
SYSTEM . Adequate protection mechanisms are described in subclause 6.7 of IEC 60601-1-
8:2006.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 65 –

Annex BB
(informative)

Alarm diagrams of Clause 208/IEC 60601-1-8:2006

The following alarm status diagrams illustrate the auditory and visual ALARM SIGNALS for
LATCHING and NON - LATCHING ALARM SIGNALS as defined in subclause 6.10 of IEC 60601-1-
8:2006 and subclause 208.6.9 of this particular standard.

ALARM H
CONDITION
L

Auditory
H
ALARM SIGNAL
L

Visual
ALARM SIGNAL H
L

ALARM RESET
H
L
Key
IEC 383/11
H Activated state

L Deactivated state

Figure BB.101 – N ON - LATCHING ALARM SIGNALS without ALARM RESET

Illustration of NON - LATCHING ALARM SIGNALS (Figure BB.101) as specified in IEC 60601-1-8
subclause 6.10: without OPERATOR interaction, the auditory and visual ALARM SIGNALS are
indicated as long as the ALARM CONDITION exists. As soon as the ALARM CONDITION ceases, the
auditory and visual ALARM SIGNALS are terminated automatically without any OPERATOR
interaction.

ALARM
CONDITION H
L

Auditory
ALARM SIGNAL H
L

Visual
ALARM SIGNAL H
L

ALARM RESET
H
L

Key IEC 384/11

H Activated state

L Deactivated state

Figure BB.102 – N ON - LATCHING ALARM SIGNALS with ALARM RESET

 BS EN 60601-2-27:2014
– 66 – 60601-2-27  IEC:2011

Illustration of NON - LATCHING ALARM SIGNALS with ALARM RESET (Figure BB.102) as specified in
IEC 60601-1-8, subclause 6.10 and in subclause 208.6.9 of this particular standard: Activating
ALARM RESET stops the auditory ALARM SIGNAL . As soon as the ALARM CONDITION ceases the
visual ALARM SIGNAL is terminated.

ALARM H
CONDITION
L

Auditory
ALARM SIGNAL H
L

Visual
ALARM SIGNAL H
L

ALARM RESET
H
L
IEC 385/11
Key

H Activated state

L Deactivated state

Figure BB.103 – L ATCHING ALARM SIGNALS with ALARM RESET

Illustration of LATCHING ALARM SIGNALS with ALARM RESET (Figure BB.103) as specified in
IEC 60601-1-8, subclause 6.10, and in subclause 208.6.9 of this particular standard: without
OPERATOR interaction, the auditory and visual ALARM SIGNALS are activated for an unlimited
time. The OPERATOR is forced to reset ALARM SIGNALS of a PHYSIOLOGICAL ALARM CONDITION by
activating the function ALARM RESET . After activating ALARM RESET the alarm behaviour
compares to NON - LATCHING ALARM SIGNALS .

ALARM
CONDITION No. 1
H
L

ALARM
CONDITION No. 2 H
L

Auditory
ALARM SIGNAL
H
L

Visual
ALARM SIGNAL H
L
ALARM RESET
H
L
IEC 386/11

Key

H Activated state

L Deactivated state

Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET

Illustration of two ALARM CONDITIONS with ALARM RESET (Figure BB.104) as specified in
IEC 60601-1-8 subclause 6.10 and in subclause 208.6.9 of this particular standard: a
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 67 –

subsequent ALARM CONDITION of another physiological parameter reactivates the auditory

ALARM SIGNAL .
 BS EN 60601-2-27:2014
– 68 – 60601-2-27  IEC:2011

Bibliography

[1] ANSI/AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms

[2] PIPBERGER, HV. et al., Recommendations for standardization of leads and of

specifications for instruments in electrocardiography and vectorcardiography. American
Heart Association, Report of the Committee on Electrocardiography, 1975, 52, p.11-31.
BS EN 60601-2-27:2014
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Index of defined terms used in this particular standard

ACCESSORY ............................................................................................. IEC 60601-1:2005, 3.3
ACCOMPANYING DOCUMENT ...................................................................... IEC 60601-1:2005, 3.4
ACTIVE ELECTRODE .................................................................... IEC 60601-2-2:2009, 201.3.203
ALARM CONDITION ................................................................................. IEC 60601-1-8:2006, 3.1
ALARM CONDITION DELAY ....................................................................... IEC 60601-1-8:2006, 3.2
ALARM LIMIT ......................................................................................... IEC 60601-1-8:2006, 3.3
ALARM OFF ........................................................................................... IEC 60601-1-8:2006, 3.4
ALARM PAUSED ..................................................................................... IEC 60601-1-8:2006, 3.5
ALARM PRESET ..................................................................................... IEC 60601-1-8:2006, 3.6
ALARM RESET ....................................................................................... IEC 60601-1-8:2006, 3.7
ALARM SETTINGS ................................................................................... IEC 60601-1-8:2006, 3.8
ALARM SIGNAL ...................................................................................... IEC 60601-1-8:2006, 3.9
ALARM SIGNAL GENERATION DELAY ....................................................... IEC 60601-1-8:2006, 3.10
ALARM SYSTEM ................................................................................... IEC 60601-1-8:2006, 3.11
AUDIO OFF .......................................................................................... IEC 60601-1-8:2006, 3.12
AUDIO PAUSED .................................................................................... IEC 60601-1-8:2006, 3.13
APPLIED PART .......................................................................................... IEC 60601-1:2005, 3.8

CLASS II ................................................................................................ IEC 60601-1:2005, 3.14

COMMON MODE REJECTION .......................................................................................... 201.3.201
CONTINUOUS OPERATION ........................................................................ IEC 60601-1:2005, 3.18

DEFIBRILLATION - PROOF APPLIED PART ..................................................... IEC 60601-1:2005, 3.20

DEGRADATION ....................................................................................... IEC 60601-1-2:2007, 3.2
DISTRIBUTED ALARM SYSTEM ................................................................ IEC 60601-1-8:2006, 3.17

EFT / B ................................................................................................ IEC 61000-4-4:2004 5) , 3.9

ELECTROCARDIOGRAPHIC ( ECG ) MONITORING EQUIPMENT ( ME EQUIPMENT ) ........................ 201.3.63
ELECTROCARDIOGRAM ( ECG ) ....................................................................................... 201.3.203
ELECTRODE ................................................................................................................ 201.3.202
ELECTROMAGNETIC COMPATIBILITY ( EMC ) ................................................ IEC 60601-1-2:2007, 3.4
EMISSION ............................................................................................. IEC 60601-1-2:2007, 3.6
ENCLOSURE ........................................................................................... IEC 60601-1:2005, 3.26
ESSENTIAL PERFORMANCE ...................................................................... IEC 60601-1:2005, 3.27

GAIN .......................................................................................................................... 201.3.204

GAIN INDICATOR .......................................................................................................... 201.3.205

HIGH PRIORITY .................................................................................... IEC 60601-1-8:2006, 3.22

—————————
5) IEC 61000-4-4:2004, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques –
Electrical fast transient/burst immunity test (referenced in Clause 2 of IEC 60601-1-2:2007)
 BS EN 60601-2-27:2014
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HF SURGICAL EQUIPMENT ............................................................ IEC 60601-2-2:2009, 201.3.222

IMMUNITY ........................................................................................... IEC 60601-1-2:2007, 3.13

IMMUNITY TEST LEVEL .......................................................................... IEC 60601-1-2:2007, 3.15
INFORMATION SIGNAL .......................................................................... IEC 60601-1-8:2006, 3.23
INTENDED USE / INTENDED PURPOSE .......................................................... IEC 60601-1:2005, 3.44
INTERBURST INTERVAL ......................................................................... IEC 60601-1-8:2006, 3.25
INTERNAL ELECTRICAL POWER SOURCE .................................................... IEC 60601-1:2005, 3.45
INTERNALLY POWERED ............................................................................ IEC 60601-1:2005, 3.46

LATCHING ALARM SIGNAL ..................................................................... IEC 60601-1-8:2006, 3.26

LEAD .......................................................................................................................... 201.3.206
LEAD SELECTOR .......................................................................................................... 201.3.207
LEAD WIRE .................................................................................................................. 201.3.208
LEAKAGE CURRENT ................................................................................. IEC 60601-1:2005, 3.47
LIFE - SUPPORTING ME EQUIPMENT ......................................................... IEC 60601-1-2:2007, 3.18
LOW PRIORITY ..................................................................................... IEC 60601-1-8:2006, 3.27

MAINS VOLTAGE ..................................................................................... IEC 60601-1:2005, 3.54

MANUFACTURER ..................................................................................... IEC 60601-1:2005, 3.55
MEDICAL ELECTRICAL EQUIPMENT ( ME EQUIPMENT ) .................................... IEC 60601-1:2005, 3.63
MEDICAL ELECTRICAL SYSTEM ( ME SYSTEM ) .............................................. IEC 60601-1:2005, 3.64
MEDIUM PRIORITY ................................................................................ IEC 60601-1-8:2006, 3.28
MULTIFUNCTION PATIENT MONITORING EQUIPMENT ........................ IEC 60601-2-49:___ 6) , 201.3.63

NEUTRAL ELECTRODE .................................................................................................. 201.3.209

NOISE ........................................................................................................................ 201.3.210
NON - LATCHING ALARM SIGNAL .............................................................. IEC 60601-1-8:2006, 3.29
NON - PERMANENT DISPLAY ........................................................................................... 201.3.211
NORMAL USE .......................................................................................... IEC 60601-1:2005, 3.71

OPERATOR ............................................................................................ IEC 60601-1:2005, 3.73

PATIENT ................................................................................................ IEC 60601-1:2005, 3.76

PATIENT CABLE .......................................................................................................... 201.3.212
PATIENT CONNECTION ............................................................................. IEC 60601-1:2005, 3.78
PATIENT LEAKAGE CURRENT .................................................................... IEC 60601-1:2005, 3.80
PERMANENT DISPLAY ................................................................................................... 201.3.213
PHYSIOLOGICAL ALARM CONDITION ........................................................ IEC 60601-1-8:2006, 3.31
PORTABLE ............................................................................................. IEC 60601-1:2005, 3.85
POTENTIAL EQUALIZATION CONDUCTOR ..................................................... IEC 60601-1:2005, 3.86

—————————
6) Second edition, to be published.
BS EN 60601-2-27:2014
60601-2-27  IEC:2011 – 71 –

RISK ................................................................................................... IEC 60601-1:2005, 3.102

RISK ANALYSIS ..................................................................................... IEC 60601-1:2005, 3.103
RISK MANAGEMENT ............................................................................... IEC 60601-1:2005, 3.107
RISK MANAGEMENT FILE ........................................................................ IEC 60601-1:2005, 3.108

SIGNAL INPUT / OUTPUT PART .................................................................. IEC 60601-1:2005, 3.115

S UPPLY MAINS ..................................................................................... IEC 60601-1:2005, 3.120

T ECHNICAL ALARM CONDITION .............................................................. IEC 60601-1-8:2006, 3.36

T RANSPORTABLE ................................................................................. IEC 60601-1:2005, 3.130
T YPE B APPLIED PART ........................................................................... IEC 60601-1:2005, 3.132
T YPE BF APPLIED PART ......................................................................... IEC 60601-1:2005, 3.133
T YPE CF APPLIED PART ......................................................................... IEC 60601-1:2005, 3.134

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