The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
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 US Food and Drug Administration review division for more information is possible. The table "Endpoints to be addressed in a biological risk assessment" was revised by the 2018 edition of ISO 10993-1. The selection of endpoints for the biocompatibility evaluation is determined by the nature of body contact and contact duration.
ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials
ISO 10993-9:2010 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10:2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2018 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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 10993-17:2009 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 10993-19:2006 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
ISO/TR 10993-22:2017 Biological evaluation of medical devices Part 22: Guidance on nanomaterials
