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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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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
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
12/20/2021 General II (ES/
EMC)		 19-41 Complete ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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