ANSI/AAMI DF80:2003/(R)2010

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Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)

Association for the Advancement of Medical Instrumentation

The Objectives and Uses of AAMI Standards and Recommended Practices

Each AAMI standard or recommended practice reflects the It is most important that the objectives and potential uses of an AAMI collective expertise of a committee of health care professionals and product standard or recommended practice are clearly understood. industrial representatives, whose work has been reviewed nationally The objectives of AAMI's technical development program derive (and sometimes internationally). As such, the consensus from AAMI's overall mission: the advancement of medical recommendations embodied in a standard or recommended practice instrumentation. Essential to such advancement are (1) a continued are intended to respond to clinical needs and, ultimately, to help increase in the safe and effective application of current technologies ensure patient safety. A standard or recommended practice is limited, to patient care, and (2) the encouragement of new technologies. It is however, in the sense that it responds generally to perceived risks and AAMI's view that standards and recommended practices can conditions that may not always be relevant to specific situations. A contribute significantly to the advancement of medical standard or recommended practice is an important reference in instrumentation, provided that they are drafted with attention to these responsible decision-making, but it should never replace responsible objectives and provided that arbitrary and restrictive uses are avoided. decisionmaking. A voluntary standard for a medical device recommends to the Despite periodic review and revision (at least once every five manufacturer the information that should be provided with or on the years), a standard or recommended practice is necessarily a static product, basic safety and performance criteria that should be condocument applied to a dynamic technology. Therefore, a standards sidered in qualifying the device for clinical use, and the measurement user must carefully review the reasons why the document was techniques that can be used to determine whether the device conforms initially developed and the specific rationale for each of its with the safety and performance criteria and/or to compare the perprovisions. This review will and is formance characteristics of This is products. Some standards em- AAMI guidance documentreveal whether the document remains different a preview edition of an to evaluate the content user. phasize the informationintended to allow potential device, that should be provided with the purchasersrelevant to the specific needs of the of the Particular decision. including performance characteristics, document before making a purchasingcare should be taken in applying a product standard to instructions for use, warnings existing devices and equipment, and in applying a recommended and precautions, and other data considered important in ensuring the practice to current procedures and practices. While observed or safe and effective use of the device in the clinical environment. For a complete often potential risks with existing Recommending the disclosure of performance characteristics copy of this AAMI document, equipment typically form the basis for the contact facilitate safety and performance criteria defined in a standard, professional necessitates the development of specialized test methods to AAMI at (877) 249-8226 judgment uniformity in reporting; reaching consensus on these tests can or visit www.aami.org.must be used in applying these criteria to existing equipment. No single source of information will serve to identify a represent a considerable part of committee work. When a drafting particular product as "unsafe". A voluntary standard can be used as committee determines that clinical concerns warrant the establishment one resource, but the ultimate decision as to product safety and of minimum safety and performance criteria, referee tests must be efficacy must take into account the specifics of its utilization and, of provided and the reasons for establishing the criteria must be course, cost-benefit considerations. Similarly, a recommended documented in the rationale. practice should be analyzed in the context of the specific needs and A recommended practice provides guidelines for the use, care, resources of the individual institution or firm. Again, the rationale and/or processing of a medical device or system. A recommended accompanying each AAMI standard and recommended practice is an practice does not address device performance per se, but rather excellent guide to the reasoning and data underlying its provision. procedures and practices that will help ensure that a device is used In summary, a standard or recommended practice is truly useful safely and effectively and that its performance will be maintained. only when it is used in conjunction with other sources of information Although a device standard is primarily directed to the manufacand policy guidance and in the context of professional experience and turer, it may also be of value to the potential purchaser or user of the judgment. device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health INTERPRETATIONS OF AAMI STANDARDS care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be AND RECOMMENDED PRACTICES used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on Requests for interpretations of AAMI standards and recommended such subjects as sterilization processing, methods of collecting data to practices must be made in writing, to the Manager for Technical establish safety and efficacy, human engineering, and other Development. An official interpretation must be approved by letter processing or evaluation techniques; such guidelines may be useful to ballot of the originating committee and subsequently reviewed and health care professionals in understanding industrial practices. approved by the AAMI Standards Board. The interpretation will In determining whether an AAMI standard or recommended become official and representation of the Association only upon practice is relevant to the specific needs of a potential user of the exhaustion of any appeals and upon publication of notice of interpredocument, several important concepts must be recognized: tation in the "Standards Monitor" section of the AAMI News. The All AAMI standards and recommended practices are voluntary Association for the Advancement of Medical Instrumentation (unless, of course, they are adopted by government regulatory or disclaims responsibility for any characterization or explanation of a procurement authorities). The application of a standard or recomstandard or recommended practice which has not been developed and mended practice is solely within the discretion and professional communicated in accordance with this procedure and which is not judgment of the user of the document. published, by appropriate notice, as an official interpretation in the AAMI News.

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American National Standard

ANSI/AAMI DF80:2003/(R)2010 (Combined revision of ANSI/AAMI DF2:1996 and ANSI/AAMI DF39:1993)

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Medical electrical equipmentPart 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)

Developed by Association for the Advancement of Medical Instrumentation Approved 23 October 2003 and Reaffirmed 20 April 2010 by American National Standards Institute, Inc.

Abstract:

This standard specifies requirements for the safety of medical electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patients skin (external electrodes) or to the exposed heart (internal electrodes). This standard does not apply to implantable defibrillators, remote control defibrillators, or separate cardiac monitors. manual defibrillator, automatic external defibrillator, AED, electromedical equipment, cardiac

Keywords:

AAMI Standard
This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations.

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This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. For a complete copy of this AAMI document, contact AAMI at (877) 249-8226 or visit www.aami.org.

Published by Association for the Advancement of Medical Instrumentation 1110 N Glebe Road, Suite 220 Arlington, VA 22201-4795 2004 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IEC, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202109

Contents
Page

Glossary of equivalent standards ............................................................................................................ vi Committee representation ......................................................................................................................viii Background.............................................................................................................................................. ix FOREWORD............................................................................................................................................ x INTRODUCTION.................................................................................................................................... xii SECTION ONE GENERAL 1 2 4 *5 6 Scope and object ..............................................................................................................................1 Terminology and definitions..............................................................................................................2 General requirements for tests .........................................................................................................5

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This is a preview edition of an AAMI guidance document and is Classification....................................................................................................................................5 intended to allow potential purchasers to evaluate the content of the Identification, marking, and documents ............................................................................................5 document before making a purchasing decision. For a complete copy of this AAMI document, or visit www.aami.org.
SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION TWO ENVIRONMENTAL CONDITIONS

10 Environmental conditions................................................................................................................10 contact AAMI at (877) 249-8226

14 Requirements related to classification ............................................................................................10 *17 *20 Separation......................................................................................................................................10 Dielectric strength ..........................................................................................................................13 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION *36 Electromagnetic compatibility (EMC).............................................................................................15 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS *42 Excessive temperatures.................................................................................................................18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection, and compatibility .............................................................................................................................18 46 Human errors ..................................................................................................................................19 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .................................................11

SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT *50 Accuracy of operating data ............................................................................................................20 51 Protection against hazardous output ..............................................................................................20 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions ........................................................................................21 SECTION TEN CONSTRUCTIONAL REQUIREMENTS *56 Components and general assembly ...............................................................................................21 57 MAINS PARTS, components and layout ............................................................................................23

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*101 102 *103 *104 *105 *106

SECTION 101preview edition of an AAMI guidance document and is This is a ADDITIONAL REQUIREMENTS RELATING TO SAFETY intended to allow potential purchasers to evaluate the content of the Charging time...............................................................................................................................23 Internal electrical document before making a purchasing decision. power source...................................................................................................26 Endurance....................................................................................................................................28 Synchronizer ................................................................................................................................28 contact AAMI at (877) 249-8226 Recovery of the MONITOR/ECG INPUTvisit www.aami.org. or after defibrillation ..............................................................28 Disturbance to the monitor from charging or internal discharging...............................................30

For a complete copy of this AAMI document,

*107 Defibrillator electrodes (U.S.)........................................................................................................50 *108 External pacing (U.S.)...................................................................................................................52 Annexes Appendix L References Publications mentioned in this Standard ......................................................37 Annex AA (informative) General guidance and rationale ......................................................................38 Annex BB (informative) AUTOMATED EXTERNAL DEFIBRILLATORS: background and rationale ..................48 Annex CC (informative) General guidance and rationale for additional U.S. requirements (U.S.) .......58 Annex DD (informative) Historical background on defibrillation waveforms (U.S.) ...............................61 Annex EE (informative) Cited references in Annexes CC and DD (U.S.) .............................................66 Tables 101 Rhythm recognition detector categories ..................................................................................9 US.DD.1 Specifications for damped sinusoidal output waveforms.......................................................64 US.DD.2 Specifications for monophasic truncated exponential output waveforms .............................65 Figures 101 102 Dynamic test for limitation of energy from different parts of the EQUIPMENT .....................31 Test apparatus for flexible cords and their anchorages ........................................................32

103 104 105 106 107 108 US.1 US.2

Arrangement for test of recovery after defibrillation ..............................................................32 Arrangement of monitoring electrodes on sponge ................................................................33 Arrangement for recovery test after defibrillation ..................................................................33 Arrangement for test of disturbance from charging and internal discharging .......................34 Isolation of DEFIBRILLATOR circuit from separate monitoring electrodes ..........................34 Examples of cord anchorages that require testing ................................................................35 Test circuit for offset instability/internal noise determination .................................................56 Test circuit for defibrillator overload test of pacing output circuitry .......................................57

US.DD.1 Damped sinusoidal waveform parameters ............................................................................64 US.DD.2 Truncated exponential waveform parameters .......................................................................65

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Glossary of equivalent standards

International standards adopted in the United States may include normative references to other international standards. For each international standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the international standard. (Note: Documents are sorted by international designation.) Other normatively referenced international standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation IEC 60601-1-2:2001 IEC 60601-2-04:2002 IEC 60601-2-21:1994 and Amendment 1:1996 IEC 60601-2-24:1998 U.S. designation ANSI/AAMI/IEC 60601-1-2:2001 ANSI/AAMI DF80:2003 ANSI/AAMI/IEC 60601-2-21 & Amendment 1:2000 (consolidated texts) Equivalency Identical Major technical variations Identical

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ANSI/AAMI ID26:1998 Major technical This is a preview edition of an AAMI guidance document and is variations intended to allow potential purchasers to evaluate the content of the IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical document before making a purchasing decision. IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical ISO 5840:1996 ISO 7198:1998 ISO 7199:1996 ISO 10993-1:2003 ISO 10993-2:1992 ISO 10993-3:2003 ISO 10993-4:2002 ISO 10993-5:1999 ISO 10993-6:1994 ISO 10993-7:1995 ISO 10993-8:2000 ISO 10993-9:1999 ISO 10993-10:2002 ISO 10993-11:1993 ISO 10993-12:2002 ISO 10993-13:1998 ISO 10993-14:2001 ISO 10993-15:2000 ISO 10993-16:1997 ANSI/AAMI/ISO 5840:1996 Identical For a complete copy of this AAMI document, contact AAMI at (877) 249-8226 ANSI/AAMI/ISO 7198:1998/2001 Identical or visit www.aami.org. ANSI/AAMI/ISO 7199:1996/(R)2002 ANSI/AAMI/ISO 10993-1:2003 ANSI/AAMI/ISO 10993-2:1993/(R)2001 ANSI/AAMI/ISO 10993-3:2003 ANSI/AAMI/ISO 10993-4:2002 ANSI/AAMI/ISO 10993-5:1999 ANSI/AAMI/ISO 10993-6:1995/(R)2001 ANSI/AAMI/ISO 10993-7:1995/(R)2001 ANSI/AAMI/ISO 10993-8:2000 ANSI/AAMI/ISO 10993-9:1999 ANSI/AAMI BE78:2002 ANSI/AAMI 10993-11:1993 ANSI/AAMI/ISO 10993-12:2002 ANSI/AAMI/ISO 10993-13:1999 ANSI/AAMI/ISO 10993-14:2001 ANSI/AAMI/ISO 10993-15:2000 ANSI/AAMI/ISO 1099316:1997/(R)2003 Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Minor technical variations Minor technical variations Identical Identical Identical Identical Identical

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International designation ISO 10993-17:2002 ISO 11134:1994 ISO 11135:1994 ISO 11137:1995 and Amdt 1:2001 ISO 11138-1:1994 ISO 11138-2:1994 ISO 11138-3:1995 ISO TS 11139:2001 ISO 11140-1:1995 and Technical Corrigendum 1:1998 ISO 11607:2003

U.S. designation ANSI/AAMI/ISO 10993-17:2002 ANSI/AAMI/ISO 11134:1993 ANSI/AAMI/ISO 11135:1994 ANSI/AAMI/ISO 11137:1994 and A1:2002 ANSI/AAMI ST59:1999 ANSI/AAMI ST21:1999 ANSI/AAMI ST19:1999 ANSI/AAMI/ISO 11139:2002 ANSI/AAMI ST60:1996

Equivalency Identical Identical Identical Identical Major technical variations Major technical variations Major technical variations Identical Major technical variations Identical

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This is a preview edition of an AAMI guidance document and is ISO 11737-1:1995 ANSI/AAMI/ISO 11737-1:1995 Identical intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical
ISO TR 13409:1996 ISO 13485:2003 ISO 13488:1996 ISO 14155-1:2003 ISO 14155-2:2003 ISO 14160:1998 ISO 14161: 2000 ISO 14937:2000 ISO 14969:1999 ISO 14971:2000 and A1:2003 ISO 15223:2000 ISO 15223/A1:2002 ISO 15225:2000 ISO 15674:2001 ISO 15675:2001 ISO TS 15843:2000 ISO TR 15844:1998 ISO TR 16142:1999 ISO 25539-1:2003 AAMI/ISO TIR13409:1996 Identical For a complete copy of this AAMI document, ANSI/AAMI/ISO 13485:2003 Identical contact AAMI at (877) 249-8226 or visit www.aami.org. ANSI/AAMI/ISO 13488:1996 Identical ANSI/AAMI/ISO 14155-1:2003 ANSI/AAMI/ISO 14155-2:2003 ANSI/AAMI/ISO 14160:1998 ANSI/AAMI/ISO 14161:2000 ANSI/AAMI/ISO 14937:2000 ANSI/AAMI/ISO 14969:1999 ANSI/AAMI/ISO 14971:2000 and A1:2003 ANSI/AAMI/ISO 15223:2000 ANSI/AAMI/ISO 15223:2000/A1:2001 ANSI/AAMI/ISO 15225:2000 ANSI/AAMI/ISO 15674:2001 ANSI/AAMI/ISO 15675:2001 ANSI/AAMI/ISO TIR15843:2000 AAMI/ISO TIR15844:1998 ANSI/AAMI/ISO TIR16142:2000 ANSI/AAMI/ISO 25539-1:2003 Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical Identical

ANSI/AAMI/ISO 11607:2000

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Committee representation
Association for the Advancement of Medical Instrumentation Defibrillator Committee This standard was developed by the Defibrillator Committee of the Association for the Advancement of Medical Instrumentation. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Defibrillator Committee had the following members: Cochairs: Members: Richard Kerber, MD Michael Willingham John Anderson, University of Ulster Robert William Bain, Prince Georges Hospital Center Carole C. Carey, RN, U. S. Food and Drug Administration Hatim M. Carim, PhD, 3M Healthcare Andrew C. Clifford, SGS Medical Devices Regis DeSilva, MD, Harvard Medical School Peter D. Gadsby, Tyco Healthcare/Ludlow This is a preview edition of an AAMI guidance document and is Leslie A. Geddes, PhD, Purdue University intendedM. Jenkins, potential purchasers to evaluate the content of the Janice to allow PhD, University of Michigan College of Engineering Gideon Kantor, PhD before making a purchasing decision. document Richard Kerber, MD, University of Iowa Healthcare Jim Miller, Philips Medical Systems For a complete copy Carl A. Pantiskas, Spacelabs Medical of this AAMI document, Cameron G. Rouns, Ballard Medical Products 249-8226 contact AAMI at (877) David Schlageter, G. E. Marquette Medical Systems or visit www.aami.org. William J. Smirles, Heartsine Technologies, Inc. W. A. Tacker, Jr., MD, PhD, Purdue University Kok-Swang Tan, PhD, Medical Devices Bureau Health Michael D. Willingham, Medtronic-Physio Control Donald Eugene Brodnick, G.E. Medical Systems Fred W. Chapman, PhD, Medtronic Physio-Control Stacy E. Gehman, BS, Philips Medical Systems/Heartstream Shen Luo, PhD, Spacelabs Medical

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Alternates:

NOTEParticipation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies.

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Background
This standard was developed by the AAMI Defibrillator Committee. The objective of this standard is to specify requirements for the safety of medical electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patients skin or to the exposed heart. This is a combined revision of ANSI/AAMI DF2:1996, Cardiac defibrillator devices and ANSI/AAMI DF39:1993, Automatic external defibrillators and remote-control defibrillators. During the course of putting this document together, the AAMI Defibrillator Committee considered identical adoption of IEC 60601-2-4:2002, Medical electrical equipmentPart 2-4: Particular requirements for the safety of cardiac defibrillator devices, which was based in large part on the previous editions of the AAMI standards noted above. In the course of reviewing the IEC standard for U.S. adoption, the committee decided that although the IEC document addressed most of the issues which the committee members felt were important, there were a few areas covered in DF2 and DF39 that had been omitted by IEC. This AAMI standard, therefore, includes all of the requirements from IEC 60601-2-4:2002 as well as some additional requirements and informative text that apply only to the AAMI standard. The additional requirements and other informative materials that relate only to the American National Standard consist of sections 107 and 108, and informative annexes CC, DD, and EE. The remaining parts of this document are also part of the American National Standard and are identical to IEC 60601-2-4. IEC 60601-2-4:2002 was developed by IEC purchasers to evaluate the contentEquipment, which is intended to allow potential Subcommittee (SC) 62D, Electromedical of the administered by AAMI on behalf of the International Electrotechnical Commission (IEC), a worldwide organization for document before making a as a previous decision. standardization. As previously noted, AAMI standards (as well purchasingedition of the IEC document) served as the basis of the international standard. In addition, the AAMI Defibrillator Committee, working as the U.S. Technical Advisory sub-Group for IECFor a complete copy of this AAMI document, SC 62D/WG2, was responsible for developing U.S. consensus on the international standard and otherwise participated in the drafting of that document.

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This is a preview edition of an AAMI guidance document and is

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The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, or visit www.aami.org. must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data comes to light. This standard reflects the conscientious efforts of concerned health care professionals and medical device manufacturers to develop a standard for those performance levels that can be reasonably achieved at this time. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. NOTEThis background does not contain provisions of the American National Standard Medical electrical equipmentPart 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators) (ANSI/AAMI DF80:2003), but it does provide important information about the development and intended use of the document.

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MEDICAL ELECTRICAL EQUIPMENT Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators) FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees. 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards This is a preview edition of an AAMI guidance document and is transparently to the maximum extent possible in their national and regional standards. Any divergence between the intended to allow potential purchasers to evaluate the content IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. of the

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document before making a cannot be rendered responsible 5) The IEC provides no marking procedure to indicate its approval andpurchasing decision. for any EQUIPMENT declared to be in conformity with one of its standards.
6) Attention is drawn to the possibilitya complete copy ofof this International Standard may be the subject of patent rights. For that some of the elements this AAMI document, The IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 60601-2-4or visit www.aami.org. sub-committee 62D: Electromedical has been prepared by equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition of IEC 60601-2-4 cancels and replaces the first edition published in 1983 of which it constitutes a technical revision. The text of this standard is based on the following documents:
FDIS 62D/455/FDIS Report on voting 62D/460/RVD

contact AAMI at (877) 249-8226

Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. Annexes AA and BB are for information only.

2004 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI DF80:2003

In this Particular Standard the following print types are used:

requirements, compliance with which can be tested, and definitions: roman type;
notes, explanations, advice, introductions, general statements, exceptions and references: smaller type;

test specifications, headings of subclauses and headings of items: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS.

The committee has decided that the contents of this publication will remain unchanged until 2007-08. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended.

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INTRODUCTION
This Particular Standard concerns the safety of CARDIAC DEFIBRILLATORS. It amends and supplements IEC 60601-1 (second edition, 1988): Medical electrical equipmentPart 1: General requirements for safety, including its amendments 1 (1991) and 2 (1995), hereinafter referred to as the General Standard. A first edition of this Particular Standard, based on the first edition (1977) of IEC 60601-1 was published in 1983. The aim of this second edition is to bring this Particular Standard up to date with reference to the publications and documents mentioned above through minor changes to the technical content. The requirements are followed by specifications for the relevant tests. A rationale for the more important requirements, where appropriate, is given in Annex AA. It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of this Particular Standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However this annex does not form part of the requirements of this standard. Clauses and subclauses for which a corresponding rationale statement is given in Annex AA are marked with an asterisk * before their number in the text.

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American National Standard

ANSI/AAMI DF80:2003/(R)2010

MEDICAL ELECTRICAL EQUIPMENT Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators) SECTION ONE GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:

1 Scope and object

This clause of the General Standard applies except as follows: *1.1 Scope Addition:

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This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS as defined in
2.1.101, hereinafter referred to as EQUIPMENT.

For a complete copy of this AAMI document,

This Particular Standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, or contact AAMI at (877) 249-8226 separate stand alone CARDIAC MONITORS (which are standardized by IEC 60601-2-27). Cardiac monitors or visit www.aami.org. which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape, delivered energy, efficacy, and safety has been specifically excluded from the scope of this standard. However, due to the critical importance of the therapeutic waveform, comments have been added to the rationale which address considerations in waveform selection. This specification defines minimum pad electrode performance. It does not ensure compatibility of a particular pad electrode-defibrillator combination nor does it ensure an acceptable level of performance. While it provides reasonable assurance of safe performance, it does not ensure compatibility of a particular pad electrode-defibrillator combination. As such, the consumer should request compatibility test information from the manufacturer(s). 1.2 Object

Replacement: The object of this Particular Standard is to establish particular requirements for the safety of DEFIBRILLATORS as defined in 2.1.101. 1.3 Particular Standards
CARDIAC

Addition: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipmentPart 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995).

2004 Association for the Advancement of Medical Instrumentation

ANSI/AAMI DF80:2003

For brevity, Part 1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(s). The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. 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 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. Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term this Standard is used to make reference to the General Standard and this Particular Standard taken together.

PREVIEW COPY

This is a preview edition of an AAMI guidance document and is Where there is no corresponding section, clause or subclause in this the content of the the section, intended to allow potential purchasers to evaluate Particular Standard, clause, or subclause document before making although possibly not relevant, applies without of the General Standard, a purchasing decision.
modification. Where it is intended thatFor apart of the General Standard, although possibly relevant, is not to be any complete copy of this AAMI document, applied, a statement to that effect is given AAMI Particular Standard. contact in this at (877) 249-8226 The requirements of this Particular Standard take priority over those of the General Standard. 1.5 Collateral Standards

or visit www.aami.org.

Addition: The following Collateral Standards apply: IEC 60601-1-1:2000, Medical electrical equipmentPart 1-1: General requirements for safetyCollateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:2001, Medical electrical equipmentPart 1-2: General requirements for safetyCollateral standard: Electromagnetic compatibilityRequirements and tests IEC 60601-1-4:1996, Medical electrical equipmentPart 1: General requirements for safety4. Collateral Standard: Programmable electrical medical systems

2 Terminology and definitions

This clause of the General Standard applies except as follows: Additional definitions: 2.1.101
CARDIAC DEFIBRILLATOR MEDICAL ELECTRICAL EQUIPMENT intended to defibrillate the heart by an electrical applied either to the PATIENTs skin (external electrodes) or to the exposed heart May be referred to as DEFIBRILLATOR or EQUIPMENT NOTE Such EQUIPMENT may also include other monitoring or therapeutic functions.

pulse via electrodes (internal electrodes).

2004 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI DF80:2003