| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 04/03/2023
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FR Recognition Number
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19-49
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| Standard | (Included in ASCA) |
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
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Scope/AbstractThis International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.
NOTE 1 See also 4.2.
The IEC 60601 series does not apply to:
- in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61];
- implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or
- medical gas pipeline systems covered by ISO 7396-1 [68].
NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. |
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| Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
FDA will accept a Declaration of Conformity to this recognized standard when the US national differences are applied. See References #1 and/or #2 below. |
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Relevant FDA Guidance and/or Supportive Publications*
US national differences:
1. (Recognition Number: 19-46) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
(https://www.iecee.org/certification/iec-test-report-forms/iec-60601-12005-iec-60601-12005amd12012-iec-60601-12005amd22020)
Other relevant FDA guidance and/or supportive publications:
- AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
- AAMI COVID-19 Emergency Guidance for the design of ventilator, resuscitator, CPAP/BiPAP systems is available at https://www.aami.org/news-resources/covid-19-updates/covid_cr. Check back frequently for the latest version as these are living documents that evolve with experience.
- IEC 60601-1 Edition 3.0 2005-12 Amendment 1 2012-07 Interpretation Sheet 1 2021-03 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance - Interpretation Sheet 1
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
