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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date
 

Title of Standard
 
 
04/04/2016 General II (ES/
EMC)
19-17 ANSI IEEE C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
04/04/2016 General II (ES/
EMC)
19-16 ANSI AAMI HA60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
06/27/2016 General II (ES/
EMC)
19-15 IEC 60601-1-12 Edition 1.0 2014-06 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
06/27/2016 General II (ES/
EMC)
19-14 IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
12/23/2019 General II (ES/
EMC)
19-13 IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
07/09/2014 General II (ES/
EMC)
19-11 UL 2054 2nd Edition Household and Commercial Batteries
07/09/2014 General II (ES/
EMC)
19-10 UL 1642 5th Edition Lithium Batteries
07/09/2014 General II (ES/
EMC)
19-9 IEC 60601-1-10 Edition 1.1 2013-11 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
09/17/2018 General II (ES/
EMC)
19-8 ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
07/09/2014 General II (ES/
EMC)
19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
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