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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/21/2020 General II (ES/
EMC)
19-39 IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION 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
12/21/2020 General II (ES/
EMC)
19-38 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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
12/21/2020 General II (ES/
EMC)
19-37 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION 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
12/21/2020 General II (ES/
EMC)
19-36 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
07/15/2019 General II (ES/
EMC)
19-35 UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
01/14/2019 General II (ES/
EMC)
19-34 IEC 61010-1 Edition 3.1 2017-01 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
12/23/2019 General II (ES/
EMC)
19-33 IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium systems
12/23/2019 General II (ES/
EMC)
19-32 IEC 62133-1 Edition 1.0 2017-02 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 - Part 1: Nickel systems
09/17/2018 General II (ES/
EMC)
19-31 ANSI IEEE C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
09/17/2018 General II (ES/
EMC)
19-30 AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
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