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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/18/2023 Anesthesiology 1-165 Complete ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
12/21/2020 General Plastic Surgery/
General Hospital		 6-450 Complete IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
06/07/2021 Radiology 12-340 Complete IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
04/03/2023 General II (ES/
EMC)		 19-34 Complete IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
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.
12/20/2021 Physical Medicine 16-232 Complete IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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