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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
08/20/2012 Cardiovascular 3-102 IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
01/14/2019 General II (ES/
19-34 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)]
06/07/2018 Biocompatibility 2-250 ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
09/17/2018 Biocompatibility 2-256 ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test