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ISO 10993-9:1999, Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
ISO TC 194/WG 2
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice
ISO/TC 194, .
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 14155-1:2003, Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-6:1994, Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO TC 194/WG 10
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-3:2003, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO TC 194/WG 5
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-12:2002, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-15:2000, Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
ISO TC 194/WG 2
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-18:2005, Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO/TS 10993-19:2006, Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-13:1998, Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO TC 194/WG 2
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-16:1997, Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
ISO TC 194/WG 2
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO/TC 194
Multiple. Distributed through American National Standards Institute (ANSI)
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ISO 10993-7:1995, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
ISO TC 194/WG 11
Multiple. Distributed through American National Standards Institute (ANSI)
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