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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
08/21/2017 Biocompatibility 2-246 ASTM F1877-16 Standard Practice for Characterization of Particles
08/21/2017 Biocompatibility 2-155 ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
08/21/2017 Biocompatibility 2-247 ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
08/21/2017 Biocompatibility 2-248 ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016 Biocompatibility 2-213 ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016 Biocompatibility 2-243 ISO /TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
12/23/2016 Biocompatibility 2-93 ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
12/23/2016 Biocompatibility 2-94 ASTM F981-04 (Reapproved 2016) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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