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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
05/26/2025 General II (ES/
EMC)		 19-56 Complete IEC 60086-4 Edition 6.0 2025-01 Primary batteries - Part 4: Safety of lithium batteries
05/26/2025 General II (ES/
EMC)		 19-55 Complete IEC 62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION 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
05/26/2025 General II (ES/
EMC)		 19-54 Complete IEC 60086-5 Edition 5.0 2021-09 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]
12/23/2024 General II (ES/
EMC)		 19-53 Complete IEC TS 60601-4-6 Edition 1.0 2024-04 Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
12/23/2024 General II (ES/
EMC)		 19-52 Complete UL 2054 Third Edition November 17, 2021 Standard For Safety Household and Commercial Batteries
12/23/2024 General II (ES/
EMC)		 19-51 Complete UL 1642 Sixth Edition September 29, 2020 Standard For Safety Lithium Batteries
05/29/2024 General II (ES/
EMC)		 19-50 Partial IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
04/03/2023 General II (ES/
EMC)		 19-49 Complete 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.
12/19/2022 General II (ES/
EMC)		 19-48 Complete IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
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