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ISO 10993 - Wikipedia Table A 1 is used to classify medical devices according to the nature (e g implant device) and duration (e g long term contact of more than 30 days) of their interaction with the human body
Biocompatibility standard ISO 10993 - UBORA ISO 10993-1 includes a table (see Table 1 below) that provides “… a framework for the development of an assessment program…” where, for the various intended uses, a general biological test strategy is described
ISO 10993-1:2025 - Biological evaluation of medical devices — Part 1 . . . ISO 10993-1 is the cornerstone standard for biological evaluation of medical devices It defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971
Toxicology Table - ISO 10993-1 - Moog Inc. ISO 10993-1 Test Matrix key = standard ISO evaluation tests 2 For all devices used in extracorporeal circuits = additional tests which may be applicable
Update on ISO 10993 - Nelson Labs “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’” issued June 16, 2016 ISO 10993 is intended as a guidance to determine the potential biological risks arising from the use of medical devices
Biocompatibility Test Matrix While the matrix has been developed as a guideline for biocompatibility evaluation, it is essential that each device be evaluated based on its own unique characteristics Please see additional Notes on backside
ISO 10993-1 and Biocompatibility - Emergo by UL Biological Evaluation Endpoints (source: FDA guidance, Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process” issued Sept 4, 2020, Table A 1
Biocompatibility Testing for Medical Devices: “The Big Three” In June 2016, the FDA released an updated Industry Guidance for the Use of International Standard ISO 10993 Among the updates in this document is an expanded table of Biocompatibility Evaluation Endpoints, which can be seen in Figure 1