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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
01/14/2019 Biocompatibility 2-145 ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
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
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
07/26/2016 Biocompatibility 2-168 ANSI AAMI ISO 10993-9:2009/(R)2014 Biological evaluation of medical devices - Part 9: Framework for identification and quantitication of potential degradation products
ISO 10993-9 Second edition 2009-12-15 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/26/2016 Biocompatibility 2-169 ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016 Biocompatibility 2-170 ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
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
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
07/26/2016 Biocompatibility 2-191 ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016 Biocompatibility 2-197 ASTM F749-13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
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