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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/21/2020 Biocompatibility 2-277 ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
07/26/2016 Biocompatibility 2-119 ASTM F813-07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
12/21/2020 Biocompatibility 2-278 ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
07/26/2016 Biocompatibility 2-122 ASTM F719-81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
12/21/2020 Biocompatibility 2-279 ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
07/26/2016 Biocompatibility 2-124 ASTM F750-87 (Reapproved 2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
12/21/2020 Biocompatibility 2-281 ISO /TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
07/26/2016 Biocompatibility 2-167 ANSI AAMI ISO TIR 10993-19:2006 Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials
ISO /TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
12/21/2020 Biocompatibility 2-280 ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
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