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FDA DRAFT Guidance - Basic Safety and Essential Performance of Medical Electrical Equipment - Standards For Accreditation Scheme

This draft guidance document outlines the standards for basic safety and essential performance of medical electrical equipment and systems as part of the Accreditation Scheme for Conformity Assessment (ASCA) Program. It provides information for industry stakeholders on the accreditation process, testing laboratory assessments, and the use of FDA-recognized consensus standards. Comments on the draft are invited within 60 days of its publication for further refinement before finalization.
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0% found this document useful (0 votes)
18 views29 pages

FDA DRAFT Guidance - Basic Safety and Essential Performance of Medical Electrical Equipment - Standards For Accreditation Scheme

This draft guidance document outlines the standards for basic safety and essential performance of medical electrical equipment and systems as part of the Accreditation Scheme for Conformity Assessment (ASCA) Program. It provides information for industry stakeholders on the accreditation process, testing laboratory assessments, and the use of FDA-recognized consensus standards. Comments on the draft are invited within 60 days of its publication for further refinement before finalization.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Contains Nonbinding Recommendations

Draft – Not for Implementation

Basic Safety and Essential


Performance of Medical Electrical
Equipment, Medical Electrical
Systems, and Laboratory Medical
Equipment – Standards Specific
Information for the Accreditation
Scheme for Conformity Assessment
(ASCA) Program
Draft Guidance for Industry,
Accreditation Bodies, Testing
Laboratories, and
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes
only.

Document issued on September 23, 2024.

You should submit comments and suggestions regarding this draft document within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane,
Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number
listed in the notice of availability that publishes in the Federal Register.

For questions about this document, For questions about this document regarding CDRH-regulated
devices, contact the ASCA Program at [email protected]. For questions about this document
regarding CBER-regulated devices, contact the Office of Communication, Outreach, and
Contains Nonbinding Recommendations

Draft – Not for Implementation


Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at [email protected].

When final, this guidance will supersede Basic Safety and Essential
Performance of Medical Electrical Equipment, Medical Electrical Systems,
and Laboratory Medical Equipment – Standards Specific Information for the
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program,
issued September 25, 2020.

U.S. Department of Health and Human Services


Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

OMB Control No. 0910-0889


Current expiration date available at https://www.reginfo.gov .
See additional PRA statement in Section VII of this guidance

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Preface
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an e-mail request to
[email protected] to receive a copy of the guidance. Please include the document
number 20001 and complete title of the guidance in the request.

CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, [email protected], or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

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Table of Contents
I. Introduction .......................................................................................................................... 1
II. Scope .................................................................................................................................... 2
III. FDA-Recognized Consensus Standards in the ASCA Program for Basic Safety and
Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and
Laboratory Medical Equipment.................................................................................................. 3
IV. Accreditation and Assessment of Testing Laboratories....................................................... 3
A. Scope of Assessments ...................................................................................................... 3
B. ASCA Program Specifications for Basic Safety and Essential Performance of Medical
Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment .......... 4
C. Scope of Accreditation Issued by Accreditation Bodies Including ASCA Basic Safety
and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and
Laboratory Medical Equipment Standards ............................................................................... 11
V. Recommendations for Participation in the ASCA Program .............................................. 11
A. Test plan development as a collaboration between device manufacturers and testing
laboratories................................................................................................................................ 11
(1) Essential Performance ................................................................................................ 12
(2) Electromagnetic Compatibility (EMC) ...................................................................... 12
B. Testing laboratory subcontracting within the Basic Safety and Essential Performance
standards of the ASCA Program ............................................................................................... 13
C. ASCA Summary Test Reports ....................................................................................... 13
(1) Concerns Identified by the Testing Laboratory .......................................................... 13
D. Devices intended to record, display, and/or analyze physiological data ........................ 14
VI. Premarket Submission Contents for FDA-Recognized Consensus Standards in the ASCA
Program for Basic Safety and Essential Performance .............................................................. 14
A. Cover Letter.................................................................................................................... 14
B. ASCA Declaration of Conformity.................................................................................. 14
C. Supplemental Documentation ........................................................................................ 15
VII. Paperwork Reduction Act of 1995 ............................................................................. 17
Appendix A: Example ASCA Declaration of Conformity (ASCA DOC) for Basic Safety and
Essential Performance Standards in the ASCA Program ......................................................... 18
Appendix B: Example ASCA Summary Test Report for Basic Safety and Essential
Performance Standards in the ASCA Program ........................................................................ 21

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1 Basic Safety and Essential


2 Performance of Medical Electrical
3 Equipment, Medical Electrical
4 Systems, and Laboratory Medical
5 Equipment – Standards Specific
6 Information for the Accreditation
7 Scheme for Conformity Assessment
8
9
(ASCA) Program
10 Draft Guidance for Industry,
11 Accreditation Bodies, Testing
12 Laboratories, and
13 Food and Drug Administration Staff
14
15 This draft guidance, when finalized, will represent the current thinking of the Food and
16 Drug Administration (FDA or Agency) on this topic. It does not establish any rights for
17 any person and is not binding on FDA or the public. You can use an alternative approach
18 if it satisfies the requirements of the applicable statutes and regulations. To discuss an
19 alternative approach, contact the FDA staff or Office responsible for this guidance as
20 listed on the title page.

21 I. Introduction
22 This guidance provides information regarding how basic safety and essential performance
23 standards are incorporated into the Accreditation Scheme for Conformity Assessment
24 Program (hereafter referred to as the ASCA Program). The ASCA Program is described in
25 FDA’s guidance on The Accreditation Scheme for Conformity Assessment (ASCA)
26 Program.
27
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28 For the edition of FDA-recognized consensus standard(s) included in the ASCA Program,
29 see the FDA Recognized Consensus Standards Database. For more information regarding use
30 of FDA-recognized consensus standards in regulatory submissions, please refer to FDA’s
31 guidances entitled Appropriate Use of Voluntary Consensus Standards in Premarket
32 Submissions for Medical Devices, Safety and Performance Based Pathway, and Standards
33 Development and the Use of Standards in Regulatory Submissions Reviewed in the Center
34 for Biologics Evaluation and Research.
35
36 FDA’s guidance documents, including this guidance, do not establish legally enforceable
37 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and
38 should be viewed only as recommendations, unless specific regulatory or statutory
39 requirements are cited. The use of the word should in Agency guidance means that
40 something is suggested or recommended, but not required.

41 II. Scope
42 This guidance includes the following:
43
44 • the ASCA Program specifications for the FDA-recognized consensus standards and
45 test methods for basic safety and essential performance;
46 • assessment and accreditation of Testing Laboratories by ASCA-recognized
47 Accreditation Bodies; and
48 • the recommended premarket submission contents specific to FDA-recognized
49 consensus standards and test methods for basic safety and essential performance
50 when testing is conducted by an ASCA-accredited testing laboratory.
51
52 FDA guidance The Accreditation Scheme for Conformity Assessment (ASCA) Program
53 describes how accreditation bodies, testing laboratories, device manufacturers, and FDA staff
54 participate in the ASCA Program as well as how FDA-recognized consensus standards and
55 test methods are selected and how Program specifications are developed.
56

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57 III. FDA-Recognized Consensus Standards in the ASCA


58 Program for Basic Safety and Essential Performance of
59 Medical Electrical Equipment, Medical Electrical
60 Systems, and Laboratory Medical Equipment
61 Evaluation of safety is critical for electrically powered medical devices. The IEC
62 60601/80601 1 series of standards applies to devices used in patient care settings, while the
63 IEC 61010 series applies to devices used in laboratory settings. FDA encourages the use of
64 these standards to support device safety in the majority of premarket submissions for
65 electrically powered medical devices. These standards take an “all-hazards approach” to
66 device safety, encompassing electrical, mechanical, and radiation hazards, among others, in
67 addition to hazards posed by the environment of use. Besides addressing the wide range of
68 generic safety requirements, the IEC 60601/80601 and IEC 61010 series include close to 100
69 “particular standards” with safety requirements for specific types of devices, such as clinical
70 thermometers, infusion pumps, infant incubators, and laboratory centrifuges.
71
72 The FDA Recognized Consensus Standards Database lists all FDA-recognized consensus
73 standards, including those included in the ASCA Program for basic safety and essential
74 performance of medical devices and laboratory equipment (note that individual test methods
75 are contained within standards). Any activities carried out by the testing laboratory under its
76 scope of ASCA Accreditation to assess the conformity of a product to one or more of these
77 standards is within the scope of the ASCA Program. The extent of FDA recognition
78 (complete or partial) is provided in the Supplemental Information Sheet (SIS) for each
79 standard included in the ASCA Program listed in the FDA Recognized Consensus Standards
80 Database. The SIS provides additional information to consider when using FDA-recognized
81 consensus standards , such as relevant guidance documents that provide clarity on FDA
82 recommendations for testing to support premarket submissions.
83

84 IV. Accreditation and Assessment of Testing Laboratories


85 A. Scope of Assessments
86 Clause 7 of ISO/IEC 17011: Conformity assessment – Requirements for accreditation bodies
87 accrediting conformity assessment bodies (hereafter referred to as “ISO/IEC 17011”)
88 describes processes by which accreditation bodies assess testing laboratories. In order to
89 maintain conformance to ISO/IEC 17011, an accreditation body assesses a sample of the
90 scope of accreditation of its accredited testing laboratories at least every two years. 2 An
91 accreditation body also performs a reassessment of its accredited testing laboratories before

1
In this document, the reference to the IEC 60601/80601 series of standards includes the ANSI/AAMI ES
60601-1, the IEC and US adopted collaterals [6060-1-xx], the IEC 60601-2-xx particulars, and the IEC or ISO
80601-2-xx particulars.
2
See 7.9.3 of ISO/IEC 17011: 2017: Conformity assessment – Requirements for accreditation bodies
accrediting conformity assessment bodies.

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92 the end of the accreditation cycle that confirms the competence of each testing laboratory for
93 all the requirements of the consensus standards within the laboratory’s scope of
94 accreditation. 3 There are no additional expectations for assessments under the ASCA
95 Program for basic safety and essential performance standards. That is, in the ASCA Program,
96 ASCA-recognized accreditation bodies may assess a sample of the basic safety and essential
97 performance standards to ensure competence across the testing laboratory’s entire scope of
98 ASCA Accreditation.
99 B. ASCA Program Specifications for Basic Safety and
100 Essential Performance of Medical Electrical Equipment,
101 Medical Electrical Systems, and Laboratory Medical
102 Equipment
103 The ASCA Program specifications in this section provide expectations for the accreditation
104 of testing laboratories for basic safety and essential performance of medical electrical
105 equipment, medical electrical systems, and laboratory medical equipment under the ASCA
106 Program. ASCA-recognized accreditation bodies, following the processes of ISO/IEC
107 17011, accredit testing laboratories to ISO/IEC 17025:2017: General requirements for the
108 competence of testing and calibration laboratories (hereafter referred to as “ISO/IEC
109 17025”) as well as to the ASCA Program specifications identified in this section.Throughout
110 the ASCA Program specifications below, the term “will” before each action for testing
111 laboratories is used to convey that they they are able to provide supportive documentation or
112 information demonstrating competence to each of the ASCA Program specifications below
113 when undergoing assessments by ASCA -recognized accrediting bodies. ASCA-recognized
114 accreditation bodies will assess the laboratories to the specifications to ensure ASCA
115 Program specifications are met.
116
117 In addition, all testing should be conducted considering the recommendations of relevant
118 FDA guidance documents (refer to Section III. of this guidance). For readability and ease of
119 reference, the numbering and nomenclature (including the term “requirements”) 4 below
120 correspond to the numbering and nomenclature of clauses/subclauses in ISO/IEC 17025.

121 ISO/IEC 17025 Clause 4 “General requirements”


122 For the purposes of the ASCA Program, testing laboratories inspect the device
123 manufacturer’s risk management file to the extent necessary to assess compliance with the
124 expectations of IEC 60601/80601 or IEC 61010. The testing laboratories do not make
125 judgments concerning the adequacy of the device manufacturer’s risk management process.
126 Nor do they make judgments concerning the acceptability of risk or the adequacy of the
127 device manufacturer’s decisions concerning risk. Each time a clause or subclause of IEC
128 60601/80601 or IEC 61010 calls for inspection of the risk management policy, plan, or

3
See 7.9.4 of ISO/IEC 17011: 2017: Conformity assessment – Requirements for accreditation bodies
accrediting conformity assessment bodies.
4
Some definitions within FDA-recognized consensus standards refer to ‘requirements.’ FDA’s references to
them for the ASCA Program do not make them legal or regulatory requirements unless specifically identified as
such.

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129 records (i.e., the risk management file), the testing laboratory is to check to see if a related
130 IEC 60601/80601 or IEC 61010 expectation has been complied with.

131 4.1 Impartiality

132 If any services, such as consulting, design, or research, are offered by the testing laboratory,
133 it will have a policy and procedure for maintaining impartiality through separation of those
134 services from its testing activities.

135
136 A device manufacturer’s internal testing laboratory will have policies and procedures that
137 specifically ensure and protect the impartiality of the laboratory to test or otherwise evaluate
138 devices manufactured by the laboratory’s parent organization and, if applicable, other device
139 manufacturers without regard to the impact of the test results on the parent organization’s
140 business interests.

141 4.2 Confidentiality


142
143 There are no additional specifications above those set forth in ISO/IEC 17025.

144 ISO/IEC 17025 Clause 5 “Structural requirements”


145
146 There are no additional specifications above those set forth in ISO/IEC 17025.

147 ISO/IEC 17025 Clause 6 “Resource requirements”

148 6.1 General


149
150 There are no additional specifications above those set forth in ISO/IEC 17025.

151 6.2 Personnel

152 a) The testing laboratory will maintain technical personnel who are qualified and
153 competent to:
154 • Establish and perform the appropriate test methods required for the standard.
155 • Understand and apply the specifications and underlying rationale (including such
156 concepts as basic safety and essential performance).
157 • Understand other normative references in the relevant standards forming part of
158 the requested scope of accreditation.
159 • Assure the suitability of means used to confirm the basic safety and essential
160 performance of the medical device under test.

161 b) The testing laboratory will:


162 • Document and maintain a program for the initial and ongoing training of technical
163 personnel, including procedures for applying new/updated test methods and
164 performing required tests.

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165 • Provide ongoing training of technical personnel at specified intervals or when test
166 standards or methods are updated or developed, as well as when responsibilities
167 have changed.
168 • Conduct training through appropriate training mechanisms, such as on-the-job
169 training or formal classroom training.
170 • Document and maintain records of training for technical personnel.

171 c) The testing laboratory will maintain job descriptions that specify and document the
172 responsibilities and required competencies of managerial, technical, and key support
173 personnel involved in requested scope of accreditation.

174 6.3 Facilities and environmental conditions


175
176 There are no additional specifications to those set forth in ISO/IEC 17025.

177 6.4 Equipment

178 a) The testing laboratory will ensure that all equipment used for testing and evaluating
179 devices is available and in proper working order for the requested scope of
180 accreditation.

181 b) The testing laboratory will ensure that its procedures specify the steps for establishing
182 calibration intervals for each type or item of equipment, and specify criteria, steps,
183 and approvals for extending the calibration interval of an instrument.

184 c) The testing laboratory will ensure that its procedures address adding, deleting,
185 modifying, or maintaining information in equipment records in an accurate and timely
186 manner, and specify the personnel responsible for these tasks.

187 d) The testing laboratory will have procedures to examine the effects of defective or out-
188 of-tolerance equipment on calibrations and tests. The testing laboratory further agrees
189 that procedures will identify the personnel responsible for such examinations, specify
190 their responsibilities, and provide the steps for the examination, including:
191 • Determining whether the effects are unacceptable (including the accept/reject
192 criteria);
193 • Identifying the devices affected;
194 • Analyzing the particular tests impacted for these devices; and determining
195 whether retesting is required;
196 • Preparing a report of the examination;
197 • Notifying customers when retesting is required; and
198 • Specifying the steps to follow to perform the retesting.

199 6.5 Metrological traceability


200
201 There are no additional specifications to those set forth in ISO/IEC 17025.

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202 6.6 Externally provided products and services


203
204 There are no additional specifications to those set forth in ISO/IEC 17025.

205 ISO/IEC 17025 Clause 7 “Process requirements”

206 7.1 Review of requests, tenders, and contracts


207 a) The testing laboratory will have contracts with customers that require the customer to:
208 • Identify those tests and test results that are intended to be used to support
209 premarket submissions to the FDA;
210 • Identify special test conditions and additions or modifications to test methods
211 and/or acceptance criteria as permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5
212 and ISO/IEC 17025 subclause 7.2.1.4; and
213 • Indicate that per the risk management requirements of IEC 60601/80601 and IEC
214 61010 the customer maintains responsibility for specifying and documenting
215 acceptance criteria.

216 7.2 Selection, verification and validation of methods

217 a) The testing laboratory agrees that its management system will include procedures
218 governing the development, maintenance, and use of test procedures (including
219 associated records in paper or electronic format such as test data forms and
220 checklists). The testing laboratory further agrees that these management system
221 procedures will include steps for:
222 • Ensuring that test procedures are documented and reviewed prior to use;
223 • Identifying the personnel responsible for developing, reviewing, and maintaining
224 test procedures;
225 • Ensuring that new and revised test procedures are reviewed by personnel who are
226 competent and trained in the applicable standard(s); and
227 • Specifying the criteria for review.

228 b) The testing laboratory agrees that test procedures and project-specific test plans will
229 include or specify, as appropriate, the following information:
230 • Unique identification of the test procedure or plan, including title, document
231 number, revision, and effective date;
232 • Specific test equipment to use or the salient performance characteristics required
233 of the equipment to be used;
234 • Warnings/caution statements to alert the operators of potential hazards;
235 • Normal and any unusual ambient conditions (including tolerances) for tests;
236 • Test data to be obtained and recorded;
237 • Objective acceptance criteria for results including the essential performance
238 required to be maintained;
239 • Testing techniques required to ensure consistent results;
240 • Instructions on equipment operation and on handling and preparation of test
241 samples (including instructions on multiple sample marking, if applicable); and

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242 • The methods to be used to assess or monitor the performance of the test sample.

243 c) The testing laboratory will ensure that relevant contextual information from the
244 intended use of the device’s essential performance specifications, including any
245 metrological stability, are reflected in the relevant test procedure or project-specific
246 test plan.

247 d) The testing laboratory will ensure that each test procedure adequately addresses all
248 the applicable requirements of the standard for the equipment under test.

249 e) The testing laboratory will give preference to using test methods in the requested
250 scope of accreditation. Modified test methods as permitted by IEC 60601-1
251 subclauses 4.2.3.2 and 4.5 and ISO/IEC 17025 subclause 7.2.1.4 may be used within
252 the ASCA Program as long as details of the rationale for the modification, test
253 method, and results are provided.

254 Note: Recommendations for how to report the modified test method can be found in
255 FDA’s guidance Recommended Content and Format of Non-Clinical Bench
256 Performance Testing Information in Premarket Submissions.

257 f) The testing laboratory will include relevant sections of the test report in the ASCA
258 Summary Test Report as necessary to explain any testing to address risks that are
259 different or in addition to those found in the FDA-recognized consensus standard.

260 g) Where a clause or subclause of the FDA-recognized consensus standard requires


261 inspection of the risk management file to obtain objective evidence, the testing
262 laboratory agrees, at a minimum, to include pass/fail criteria in the inspection
263 procedure and record the list of documents examined during the inspection in the
264 testing laboratory’s records.

265 7.3 Sampling


266
267 There are no additional specifications to those set forth in ISO/IEC 17025.

268 7.4 Handling of test or calibration items


269
270 There are no additional specifications to those set forth in ISO/IEC 17025.

271 7.5 Technical records


272
273 There are no additional specifications to those set forth in ISO/IEC 17025.

274 7.6 Evaluation of measurement uncertainty


275
276 There are no additional specifications to those set forth in ISO/IEC 17025.

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277 7.7 Ensuring the validity of results


278
279 There are no additional specifications to those set forth in ISO/IEC 17025.

280 7.8 Reporting of results

281 a) The testing laboratory will have procedures to record and report all required
282 information in ISO/IEC 17025 for each test conducted, including the following:
283 • A statement of the extent to which the articles that were tested complied or did
284 not comply with the specifications of each clause or subclause that were part of
285 the standard tested;
286 • A detailed description of the medical device tested including accessories, options,
287 software versions, and configurations tested;
288 • A test plan including reference to the device manufacturer’s stated intended use
289 and essential performance claims monitored during testing, any additional device-
290 specific acceptance criteria (beyond those detailed in specific consensus
291 standards) monitored during testing, reporting of the operational state(s) of the
292 equipment during each test, as well as, if needed, any modified test methods as
293 permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5 and ISO/IEC 17025
294 subclause 7.2.1.4.
295
296 Note: Recommendations for how to report the modified test methods can be found
297 in the guidance document Recommended Content and Format of Non-Clinical
298 Bench Performance Testing Information in Premarket Submissions.
299
300 • The date and location of the test(s) performed;
301 • The test report’s unique identifier;
302 • The signatures and printed names of the personnel responsible for the test results;
303 • The test conditions, e.g., supply voltage, ambient temperature or humidity, when
304 relevant to the test;
305 • All of the applicable data required for equipment under test according to the
306 standard;
307 • A statement of the estimated uncertainty of measurement, when it is relevant to
308 the validity or application of the test results, when a customer’s instructions so
309 requires or when the uncertainty affects compliance to a specification limit; and
310 • A statement that test report meets ASCA Program specifications.
311
312 b) The testing laboratory agrees not to report test results in a “simplified way” as
313 mentioned in subclause 7.8.1.3. Instead, the testing laboratory will report to the
314 customer all information listed in subclauses 7.8.2 through 7.8.7 to the extent
315 applicable (Subclause 7.8.4 is for calibration certificates and is not applicable when
316 testing to the requirements of IEC 60601).
317

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318 c) The testing laboratory will convey to the customer, in writing, all opinions and
319 interpretations, including concerns about basic safety and essential performance such
320 as:
321 • Anomalous test results noted during any part of the testing that were not resolved
322 to the testing laboratory’s satisfaction; and
323 • Concerns regarding any other aspect of conformity to the standard.

324 d) The testing laboratory will require that testing conducted by subcontractors will also
325 comply with the above test report specifications, as applicable.

326 e) The testing laboratory agrees that an ASCA Summary Test Report including the
327 content specified in this guidance will be submitted to the customer at the end of
328 testing activities.

329 f) The testing laboratory will convey to the customer, in writing, all observations
330 recorded during execution of a project test plan.
331
332 Note. An observation is a device behavior that is not directly related to the pass/fail
333 assessment being made at that time. An observation is recorded to make the customer
334 aware of a device behavior that, while it might be out-of-scope for the test plan being
335 executed, could indicate a potential quality issue. It is the customer’s responsibility to
336 assess this further.

337 7.9 Complaints


338
339 There are no additional specifications to those set forth in ISO/IEC 17025.

340 7.10 Nonconforming work


341
342 There are no additional specifications to those set forth in ISO/IEC 17025.

343 7.11 Control of data and information management


344
345 There are no additional specifications to those set forth in ISO/IEC 17025.

346 ISO/IEC 17025 Clause 8 “Management system requirements”

347 8.1 Options


348 Regardless of the option selected (i.e., ISO/I”aEC 17025 Option A or Option B), the testing
349 laboratory will maintain an index of standard operating procedures (SOPs) and any relevant
350 ASCA test-related documents (i.e., SOPs, test methods, work instructions, master protocols,
351 test-specific protocols, data collection worksheets, training information, completed ASCA
352 Summary Test Reports, and associated complete test reports) applicable to any of the
353 relevant FDA-recognized consensus standards included in the ASCA Program for basic
354 safety and essential performance of medical devices and laboratory equipment and the
355 associated specifications detailed in this document.

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356 C. Scope of Accreditation Issued by Accreditation Bodies


357 Including ASCA Basic Safety and Essential Performance of
358 Medical Electrical Equipment, Medical Electrical Systems,
359 and Laboratory Medical Equipment Standards
360 Once testing laboratories have been assessed by an ASCA-recognized accreditation body to
361 ISO/IEC 17025 and the ASCA Program specifications identified in Section IV.B of this
362 guidance, the accreditation body will issue a proposed scope of accreditation under the
363 ASCA Program to the testing laboratory (see sample in Appendix D of ASCA Program
364 guidance document). The testing laboratory should work with their accreditation body to
365 ensure the applicable exclusions are accurately and clearly listed in the ASCA section of the
366 scope of accreditation.
367
368 Appendix D of the ASCA Program guidance document highlights that the scope of ASCA
369 Accreditation Ashould accurately capture when excluded clauses and/or subclauses of one
370 standard may also apply to others within the scope of accreditation. For example, excluded
371 subclauses of ANSI AAMI ES60601-1 (referred to as the “general standard” throughout the
372 collaterals and particulars of the 60601/80601 series of standards) will also apply to the
373 applicable collateral and particular standards in the scope of accreditation that reference the
374 excluded clauses/subclauses (e.g., particulars can state “Clause 11 of the general standard
375 applies,” or “Clause 8 of the general standard applies except as follows…” adding an
376 additional subclause or requirement that could be excluded if Clause 8 or subclause 8.x.x.x is
377 excluded in ANSI AAMI ES60601-1). The testing laboratory should work with their
378 accreditation body to ensure these types of exclusions are accurately and clearly captured in
379 the conditional and any subsequently updated accreditation.
380
381 Testing laboratories should also consider the recommendations in Appendix B of this
382 guidance, regarding representing exclusions to the scope of accreditation under the ASCA
383 Program in the Clauses/Subclauses Tested section of the ASCA Summary Test Report.
384

385 V. Recommendations for Participation in the ASCA


386 Program
387 A. Test plan development as a collaboration between
388 device manufacturers and testing laboratories
389 As described in the draft ASCA Program guidance document, FDA recommends device
390 manufacturers consult with ASCA-accredited testing laboratories when developing a
391 comprehensive test plan for their device. FDA encourages a collaborative relationship
392 between the device manufacturer and testing laboratory wherever possible. Such
393 collaboration may help to ensure the appropriate selection and use of FDA-recognized
394 consensus standards and test methods.
395

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396 If the testing laboratory has questions or concerns associated with the device manufacturer’s
397 proposed test plan (e.g., essential performance(s), unclear acceptance criteria), they should
398 discuss such concerns/questions with the device manufacturer, preferentially in advance of
399 finalization of the test plan. If those concerns or questions remain unresolved, the testing
400 laboratory should consider detailing the potential issues in the ASCA Summary Test Report
401 (e.g., in the Concerns Identified section in the example provided in Appendix B of this
402 guidance).
403 (1) Essential Performance
404 FDA recommends the device manufacturer specifies the essential performance(s) of their
405 device. Additionally, testing laboratories should have expertise in the terminology,
406 evaluation, and performance of the FDA-recognized consensus standards to assist a device
407 manufacturer in understanding the concept of essential performance and how it might relate
408 to their device, as appropriate.
409
410 We recommend that testing laboratories and device manufacturers consider the content of the
411 AAMI consensus report CR500:2019, Basic Introduction to the IEC 60601 Series, which
412 includes clarifications to help device manufacturers understand “essential performance.” 5
413
414 If a device manufacturer is unsure what constitutes the essential performance(s) of their
415 device, FDA recommends submitting a Q-submission 6 prior to initiating testing to request
416 formal feedback from the appropriate CDRH Office of Health Technology (OHT) or CBER
417 Review Office for their future premarket submission. For information on presubmissions,
418 please see the FDA guidance entitled “Requests for Feedback and Meetings for Medical
419 Device Submissions: The Q-Submission Program.”
420 (2) Electromagnetic Compatibility (EMC)
421 For test plans that intend to use the current, FDA-recognized version of the IEC 60601-1-2
422 collateral standard, we recommend that device manufacturers and testing laboratories
423 consider the FDA guidance entitled “Electromagnetic Compatibility (EMC) of Medical
424 Devices.” This guidance provides recommendations that might impact test plans including
425 current, FDA-recognized versions of IEC 60601-1-2.
426
427

5
For additional information about a regulatory perspective on “essential performance,” we recommend the
AAMI consensus report entitled CR500:2019 Basic Introduction to the IEC 60601 Series.
6
For more information, please see the FDA guidance entitled “Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program.”

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428 B. Testing laboratory subcontracting within the Basic


429 Safety and Essential Performance standards of the ASCA
430 Program
431 ASCA-accredited testing laboratories may subcontract testing, as allowed in ISO/IEC 17025
432 and the ASCA specifications listed above, as long as that the outscourcedtesting is included
433 in the ASCA-accredited testing laboratory’s scope of ASCA Accreditation (i.e., the testing
434 laboratory issuing the ASCA Summary Test Report). Ultimately, the ASCA-accredited
435 testing laboratory is responsible for the data, testing methodology, and results presented in
436 the test reports provided to the device manufacturer.
437 C. ASCA Summary Test Reports
438 Appendix B of this guidance contains an example ASCA Summary Test Report that includes
439 the information needed to support premarket review.
440
441 Testing laboratories participating in the ASCA Program may devise their own ASCA
442 Summary Test Report formats; however, the requested information outlined in each section
443 of Appendix B should be addressed.
444
445 FDA recommends device manufacturers review the example in Appendix B to familiarize
446 themselves with the content of an ASCA Summary Test Report.
447 (1) Concerns Identified by the Testing Laboratory
448 If the testing laboratory identifies any concerns with the evaluation of the device, they should
449 communicate these concerns to the device manufacturer and work to resolve them prior to
450 the issuance of the ASCA Summary Test Report. In situations where concerns remain
451 unresolved, the testing laboratory should detail the concerns in the ASCA Summary Test
452 Report. For example, by using the “Concerns Identified” section included in the example
453 ASCA Summary Test Report (Refer to Appendix B of this guidance).
454
455 Examples of potential concerns that the testing laboratory may identify include, but are not
456 limited to, concerns with the:
457
458 • test plan (e.g., unclear pass/fail criteria or essential performance(s),
459 • risk analysis (e.g., underestimation of risk level, unidentified risks related to the
460 device) based on the test lab’s experience with specific device types, or
461 • presence of unique device features or characteristics that may raise safety concerns
462 which may not be sufficiently assessed via the device manufacturer’s test plan.
463
464 FDA recommends device manufacturers address any concerns identified in the ASCA
465 Summary Test Report in their declaration of conformity for the ASCA Program (ASCA
466 DOC) and reference relevant sections of their premarket submission containing supporting
467 documentation which may further mitigate any concerns identified by the testing laboratory.

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468 D. Devices intended to record, display, and/or analyze


469 physiological data
470 Devices that are intended to record, display, and/or analyze physiological data (e.g.,
471 electrocardiographs) have inherent clinical components/performances/uses that cannot be
472 directly evaluated by a testing laboratory. In testing these types of devices to FDA-
473 recognized consensus standards, the performance of the device is typically monitored and
474 evaluated for any observations or degradations which impact the intended performance (e.g.,
475 assessment of the performance of devices exposed to electromagnetic disturbances). 7
476
477 If observations or degradations related to the recording, display and/or analysis of data are
478 noted for these device types, the test report should include a description of the observations
479 or degradations alongside representative data demonstrating the observed behavior in the
480 Observations and Degradations During Testing section of the ASCA Summary Test Report
481 or as an attachment to the report.

482 VI. Premarket Submission Contents for FDA-Recognized


483 Consensus Standards in the ASCA Program for Basic
484 Safety and Essential Performance
485 FDA recommends that the following be included in any regulatory submission that reports
486 basic safety and essential performance testing conducted by an ASCA-accredited testing
487 laboratory.
488 A. Cover Letter
489 FDA recommendations for a cover letter for a premarket submission containing testing
490 results from an ASCA-accredited testing laboratory are provided in FDA’s draft guidance
491 The Accreditation Scheme for Conformity Assessment (ASCA) Program.
492 B. ASCA Declaration of Conformity
493 Section IV.A. of FDA’s guidance Appropriate Use of Voluntary Consensus Standards in
494 Premarket Submissions for Medical Devices recommends contents for a DOC to an FDA-
495 recognized consensus standard. For basic safety and essential performance testing from an
496 ASCA-accredited testing laboratory, the device manufacturers should include the following
497 additional items in an ASCA DOC:
498 • Date(s) the testing was conducted.
499 • Location(s) where the testing was conducted.
500 • Confirmation that the FDA-recognized consensus standards used during testing were
501 within the laboratory’s scope of ASCA Accreditation and that such standards were not

7
For more information, please see the FDA guidance entitled “Electromagnetic Compatibility (EMC) of
Medical Devices” (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/electromagnetic-compatibility-emc-medical-devices) and IEC TR 60601-4-2.

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502 suspended from the scope of ASCA Accreditation at the time testing was conducted. If
503 the relevant standard was impacted by a suspension of ASCA Accreditation, the
504 ASCA DOC should include an explanation of how this suspension may or may not
505 affect the testing results.
506 • Limitations on the validity of the ASCA DOC:
507 • How the test article compares with the device provided in the premarket
508 submission, including any modifications made during testing. If modifications
509 were made during testing, it is helpful if the ASCA DOC states whether or not
510 these modifications are included in the final finished device. FDA also
511 recommends that the ASCA DOC include a rationale for why it was deemed
512 appropriate to leverage any testing conducted before the modifications were
513 made.
514 • Details about how any concerns communicated by the test laboratory have been
515 mitigated (see Section V.C.1. above).
516 • Details about how any observations and/or degradations during testing were
517 resolved.
518 • If there is additional data or documentation that support any of the limitations on
519 the validity of the ASCA DOC, FDA recommends that a reference identifying
520 where to find this information be provided in the ASCA DOC.

521 An example ASCA DOC is provided in Appendix A of this guidance.


522 C. Supplemental Documentation
523 In lieu of submitting the full test report, FDA recommends that testing performed under the
524 ASCA program be submitted using the recommended ASCA Summary Test Report format. 8
525 An example ASCA Summary Test Report is provided in Appendix B of this guidance. Note
526 that the ASCA-accredited testing laboratory provides the ASCA Summary Test Report to the
527 device manufacturer who then includes it with its own ASCA DOC in a premarket
528 submission to FDA.
529
530 Under the ASCA Program, FDA generally will accept test results from ASCA-accredited
531 testing laboratories when the standard and test methods are within the testing laboratory’s
532 scope of ASCA Accreditation at the time of testing. Examples of circumstances where FDA
533 might request and review additional information relating to testing from an ASCA-accredited
534 testing laboratory are described in the bulleted points of Section XIII.A of the ASCA
535 Program guidance.
536
537 The ASCA Program processes and policies enhance confidence in testing results only when
538 specific test methods and acceptance criteria are used. In cases where the standard permits

8
An ASCA Summary Test Report is different from the test report summary described in FDA’s guidance
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket
Submissions.

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539 modifications or additions to individual clauses or subclauses to ensure basic safety and
540 essential performance, FDA recommends the submitter include the test plan and procedure,
541 acceptance criteria, and results justifying the safety claim in its premarket submission. In
542 such cases, FDA recommends that the ASCA Summary Test Report include relevant
543 information about the testing that was performed. The following examples illustrate a few
544 situations where this additional documentation is appropriate:
545
546 • Where a test method specified in a clause or subclause of the standard was modified
547 based on specific characteristics and/or intended use of the device or its operating
548 conditions.
549 • Where the acceptance criteria specified in a clause or subclause was modified based
550 on the device manufacturer’s risk management.
551 • Where clauses or subclauses in the IEC 60601/80601 and IEC 61010 series do not
552 provide specific test methods and acceptance criteria. For example, a clause or
553 subclause might indicate “compliance is checked by inspection of the risk
554 management file and functional tests, if necessary.” In other cases, a clause or
555 subclause might provide for revision of the specific test methods and acceptance
556 criteria based on risk management.

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557 VII. Paperwork Reduction Act of 1995


558
559 This guidance contains information collection provisions that are subject to review by the Office
560 of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
561 3501-3521).
562
563 The time required to complete this information collection is estimated 9 to average 95 hours per
564 response for accreditation bodies and 47 hours for testing laboratories. Send comments regarding
565 this burden estimate or suggestions for reducing this burden to:
566
567 FDA PRA Staff,
568 Office of Operations,
569 Food and Drug Administration,
570 [email protected]
571
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The
OMB control number for this information collection is 0910-0889 (To find the current
expiration date, search for this OMB control number available at
https://www.reginfo.gov).
572
573
574

9
Rounded to the nearest whole number.

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575 Appendix A: Example ASCA Declaration of Conformity


576 (ASCA DOC) for Basic Safety and Essential Performance
577 Standards in the ASCA Program
578 Note: This example is intended to illustrate elements expected in an ASCA DOC. The content
579 of an ASCA DOC expands on the content of a DOC described in FDA’s guidance
580 Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
581 Devices. 10 Submitters should include an ASCA DOC as part of their premarket submission
582 when including ASCA testing (i.e., an ASCA Summary Test Report).
583
584 Responsible Party
585 Name of entity responsible for DOC: ____________________________________________
586 Address of entity responsible for DOC: ___________________________________________
587
588 Product/Device Identification

All identifying information for the product/device (e.g., product code(s), device marketing
name(s), model number(s), etc.).
589
590 Statement of Conformity
591 The test results demonstrate that the device is in conformity with the standard(s) listed
592 below 11:
593 • Title of Standard(s): 12 (e.g., ANSI/AAMI ES60601-1 Medical electrical equipment
594 - Part 1: General requirements for basic safety and essential
595 performance.)______
596 • FDA Recognition #(s): (e.g., 19-46)
597 • Options Selected
598  Standard(s) included no options
599  Standard(s) included options

List of options selected in related standard(s) (e.g., subclause 5.3 permits


modified test conditions if ambient temperature cannot be maintained). This
section may reference the ASCA Summary Test Report provided as
supplementary documentation.
600 • Testing Laboratory Name: (e.g., Testing Laboratory ABC)
601 • ASCA Testing Laboratory Identification Number(s): (e.g., TL-01)

10
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices
11
See section 514(c)(3)(A)(i) of the FD&C Act, cited in Section IV.A.(3)(f) of FDA’s guidance Appropriate
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Device.
12
A device manufacturer may declare conformity to multiple standards evaluated by a test lab within the ASCA
Program.

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602 • Testing Location(s): (e.g., 1234 Example Road, Silver Spring, MD 20993)
603 • Testing Date(s): (e.g., Sep 1, 2023 – Sep 15, 2023)
604 • ASCA Accreditation Status on the Date(s) of Testing:
605  Standard was not in testing laboratory’s scope of ASCA Accreditation
606  Standard was in testing laboratory’s scope of ASCA Accreditation;
607  ASCA Accreditation was not suspended
608  ASCA Accreditation was suspended

If ASCA Accreditation was suspended during the testing date(s), a description


of reasons for suspension and their impact on testing results should be
provided. FDA may need to review additional information and/or ask questions
to determine whether the test results can be used to support a decision on a
premarket submission.

Note: if the testing laboratory’s ASCA Accreditation was suspended or


withdrawn at the time of testing, an ASCA DOC may not be submitted for the
suspended or withdrawn FDA-recognized consensus standards and test
methods. However, the submitter may submit a DOC as outlined in FDA’s
guidance Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices.

609 • Supplemental Documentation (Refer to Section VI.C. of this guidance for specific
610 recommendations):
611  Supplemental documentation is not included
612  Supplemental documentation is included at the following location within the
613 submission, and I have checked that there are no differences regarding
614 protocol and data between the testing conducted and the supplemental
615 documentation: (e.g., IEC 60601-1-2 ASCA Summary Test Report located in
616 Appendix A of this premarket submission)__________
617
618

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619 Limitations on Validity of DOC


620

Description of any limitation on the validity of the ASCA DOC (e.g., how long the declaration is
valid, what was tested, or concessions made about the testing outcomes) including a reference to
the relevant locations of such information in the premarket submission. For testing from an
ASCA-accredited test lab, this should include:

• Information on how the test article compares with the device provided in this
premarket submission including, any modifications made during testing for basic
safety and essential performance and whether the modifications are included in the
final, finished device.
• Information on how any concerns communicated by the test laboratory were
resolved.
• Information on how any observations and/or degradations during testing were
resolved.
• Information about how conformity was assessed for clauses or subclauses of the
relevant standard(s) that were not evaluated by an ASCA-accredited testing
laboratory, including detailed information about who performed such testing, the test
methods used, and the test results
• Information on how the labeling requirements of the standard are met (e.g.,
reference to relevant section/pages of the user manual).

621
622
623 Signature
624 Printed name: _______________________________________________________________
625 Function within entity responsible for DOC: _______________________________________
626
627 ___________________________________________________________________________
628 Signature Date
629
630

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631 Appendix B: Example ASCA Summary Test Report for


632 Basic Safety and Essential Performance Standards in the
633 ASCA Program
634 Note: This example is intended to illustrate the supplemental documentation that should
635 accompany the ASCA DOC as described in Appendix A. The ASCA Summary Test Report is
636 provided by the testing laboratory to the device manufacturer.

637 Administrative Information


638
639 1. Testing Laboratory Name:
640 2. ASCA Testing Laboratory Identification Number:
641 3. Testing Location(s):
642 4. Testing Date(s):
643 5. Standard(s) evaluated:
644
FDA Standard Designation Number Tested conducted under
Recognition the ASCA Program (Y/N)
Number
e.g., 19-4 e.g., ANSI AAMI ES60601-1 Y
… … …
645
646
647 6. ASCA Accreditation Status on the Date(s) of Testing:
648  Standard was *NOT* in testing laboratory’s scope of ASCA Accreditation 13
649  Standard was in testing laboratory’s scope of ASCA Accreditation
650  ASCA Accreditation was not suspended
651  ASCA Accreditation was suspended

If ASCA Accreditation was suspended during the Date(s) of testing, a description


of reasons for suspension and their impact on testing results should be provided.

Note: if the testing laboratory’s ASCA Accreditation was suspended or withdrawn


at the time of testing, an ASCA DOC may not be submitted for the suspended or
withdrawn FDA-recognized consensus standards and test methods. However, the
submitter may submit a DOC as outlined in FDA’s guidance Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical Devices
652
653

13
See FDA’s guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized
consensus standards that are not in a testing laboratory’s scope of ASCA Accreditation.

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654 Device Essential Performance Characteristics

Description of the device essential performance characteristics supplied by the device


manufacturer to the testing laboratory (including reference to any relevant particular
standards with essential performance specified) and that were included in the testing. List
any differences (if any identified) between the essential performance identified by the
standard and the essential performance considered during the test. For multiple standards
and/or multiple tests, include the essential performance characteristics used for each.
655
656
657 Device Pass/Fail Criteria
Description of any Pass/Fail criteria specific to the device beyond the requirements
specified in the standard(s) being evaluated. This should include a brief description for how
these criteria were identified and monitored during the testing.

Pass/Fail criteria specific to the device should be clear and verifiable. Pass/Fail criteria
might include device-specific criteria for clinical functions unrelated to identified essential
performance.
658
659 Use Environment
660  Home Healthcare Environment [IEC 60601-1-11]
661  Professional Healthcare Facility Environment
662  Magnetic Resonance (MR) Environment
663  Commercial Aircraft Environment
664  Emergency Medical Services Environment [IEC 60601-1-12]
665  Special / Other Environment
666

Include any relevant details regarding the specified use environment here.

667 Clauses/Subclauses Tested


668 1. Clauses/Subclauses Deemed Applicable
669  All clauses/subclauses were deemed applicable.
670  The following clauses/subclauses were deemed not applicable.
671

List of all clauses and subclauses identified as not applicable (N/A) with a rationale for
every clause/subclause identified as N/A. This may be provided as an attachment to the
Summary Test Report.

If specific clauses/subclauses are excluded on the testing laboratory’s scope of


accreditation, they should be listed either as N/A in this section, if appropriate, or in the next
section as a clause or subclause that was not tested.
672

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673 2. Clauses/Subclauses Tested


674  All applicable clauses/subclauses were tested
For clauses or subclauses allowing multiple test methods, list the specific clause or
subclause and test method used with a brief rationale for the choice.
675
676  The following applicable clauses/subclauses were not tested.

List of any applicable clauses or subclauses not tested. Rationales should also be provided
to clarify why applicable clauses/subclauses were not tested.

If specific clauses or subclauses are determined to be applicable but are not within the
testing laboratory’s scope of accreditation (i.e., excluded in the scope of accreditation),
then those clauses/subclauses should be listed here with a corresponding explanation.
677
678 3. Clauses/Subclauses with Failing Results
679  No clauses or subclauses had failing results
680  The following clauses/subclauses had failing results

List of any clauses and subclauses with failing results and a description of the failures.

681 Modification(s) 14 to Test Methods and/or Acceptance Criteria


682  No test methods specified in the standard were modified
683  No acceptance criteria specified in the standard were modified
684  One or more test methods or acceptance criteria were modified

List of test methods and/or acceptance criteria that were modified. Appropriate supporting
documents should be attached to this ASCA Summary Test Report including the rationale for
the modification, test plan and procedure, acceptance criteria that were applied, scientific
rationale for the acceptance criteria, and the test results.

685 Additional Testing Performed to Demonstrate Conformity with the Standard 15


686  No additional testing was performed other than that specified in the standard
687  Additional testing was performed as specified by the device manufacturer to address a
688 hazardous situation not specifically addressed by the standard
689

14
Modification(s) include special test conditions and additions or modifications to test methods and/or
acceptance criteria as permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5 and ISO/IEC 17025 subclause
7.2.1.4.
15
For example, subclause 4.2 of ANSI/AAMI ES60601 indicates that hazards not specifically addressed in the
ANSI/AAMI ES60601-1 are to be addressed in the risk management process.

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Description of additional testing performed to address a hazardous situation not specifically


addressed by the standard. Appropriate supporting documents are attached to this ASCA
Summary Test Report including the test plan and procedure, acceptance criteria that were
applied, and the test results.

690 Device Configuration(s) and Mode(s) of Operation

Description of how device was configured including modes of operation used during testing.

691 Observations and Degradations During Testing


692  Observations and degradations were NOT found during testing
693  Observations and degradations were found, but deemed acceptable based on the pass/fail
694 criteria identified by the device manufacturer
695

Description of observations and degradations of concern to the testing laboratory but deemed
acceptable. Examples include:

• Instances of device showing unexpected behaviors (e.g., display of incorrect values,


display of error messages, device or components needing to be restarted, if the device
or components restart unexpectedly).
o Representative bench data should be provided to visualize the unexpected
behaviors observed affecting devices intended to record, display, and/or analyze
physiological data
• Instances of device or components being unexpectedly damaged and needing
replacement or other intervention to return to normal operation.

This list should capture any unexpected events. As an example, an error message would be
unexpected (and therefore would be listed) during EMC testing when a valid input is present;
conversely, the same error message would be expected (and therefore would not be listed)
during a test that feeds an out-of-range input to verify the function of input errors. Any
unexpected behavior is reported even if acceptable per the pass/fail criteria. If the unexpected
behavior is listed as possible in the labeling (e.g., “the device may restart unexpectedly”), it
should still be reported here.
696
697 Modifications to Test Article(s) During Testing
698  No modifications were made to the test articles during testing
699  Modifications were made to the test articles during testing. Description of modification
700 including their impact on prior test outcome(s) are provided below.

Description of modifications made to test articles during testing. Description of prior tests that
were repeated based on modifications made or justification for not repeating prior tests.

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701 Concerns Identified


702  No concerns were identified.
703  Concerns were communicated to the device manufacturer; see list below.
List and description of concerns communicated to the device manufacturer.

Concerns may include aspects that do not constitute a failure for the specific test conducted,
but might have an impact on the safety and potential effectiveness of the device subject to the
testing. Examples include, but are not limited to, concerns regarding the test plan (e.g., unclear
pass/fail criteria or essential performance(s), disagreements regarding the evaluation of
certain clauses or subclauses), inconsistencies in risk analysis (e.g., underestimation of risk
level, unidentified risks related to the device) based on the test laboratory’s experience with
specific device types, presence of unique features/characteristics which may raise safety
questions not addressed via the test plan.

704
705 I confirm that:
706  The above summary information includes all original and any retest data
707  The above summary information is an accurate representation of the testing conducted
708
709
710
711 __________________________________________________________________________
712 Name: [TYPED NAME POSITION] Date
713

25

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