ISO 10993-1:2009 & FDA endpoints for consideration
The following table provides a framework for the development of a biocompatibility evaluation. Different biological endpoints may require evaluation for particular medical devices, including either additional or fewer endpoints than indicated. If it is unclear in which category a device falls, consulting device-specific guidances or contacting the appropriate USList of the standards in the 10993 series
*ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process *ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements *ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity *ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood *ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. *ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation *ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals *ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials (withdrawn) *ISO 10993-9:2019 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products *ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization *ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity *ISO 10993-12:2021 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only) *ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices *ISO 10993-14:2009 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics *ISO 10993-15:2009 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys *ISO 10993-16:2018 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 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process *ISO/TS 10993-19:2020 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 *ISO/TR 10993-22:2017 Biological evaluation of medical devices Part 22: Guidance on nanomaterials *ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation *ISO/TR 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3See also
* List of ISO standardsReferences
{{DEFAULTSORT:Iso 10993 #10993 Regulation of medical devices Medical devices