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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
07/26/2016 Biocompatibility 2-133 ASTM F1408-97 (Reapproved 2013) Standard Practice for Subcutaneous Screening Test for Implant Materials
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
01/30/2014 Biocompatibility 2-205 ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
ISO 14155 Second edition 2011-02-01 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
12/21/2020 Biocompatibility 2-283 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/26/2016 Biocompatibility 2-214 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
12/21/2020 Biocompatibility 2-284 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/21/2020 Biocompatibility 2-285 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Elution Test
12/21/2020 Biocompatibility 2-286 USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
12/21/2020 Biocompatibility 2-288 ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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