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The ISO 10993 set entails a series of standards for evaluating the biocompatibility of a medical device prior to a clinical study. These documents were preceded by the Tripartite agreement and is a part of the harmonisation of the safe use evaluation of medical devices.
[edit] List of the standards in the 10993 series
- ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing
- ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
- ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-5:1999 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- ISO 10993-7:1995 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-10:2002/Amd 1:2006 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-12:2002 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
- ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
- ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
- ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
- ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
- ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
- ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
