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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
 
 
12/20/2021 Biocompatibility 2-295 USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
12/19/2022 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
07/26/2016 Biocompatibility 2-174 ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
12/19/2022 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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