ISO 10993 Biocompatibility Assessment Resource Centre

May 10, 2021
By M.Turner

The FDA CDRH has recently made a resource available to assist and guide evaluations.


This useful resource is found at takes a step by step approach, guiding the user through device definitions, the required endpoints, what to test and how to report. Perhaps the most useful feature is guidance on how to describe and compare material, component or processing changes made to previously marketed devices. The advice and guidance is generally transferred from FDA Guidance

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

As well as, describing the general steps for device manufacturers to follow there is glossary and other helpful information.

MET provides a complete service for your biocompatibility requirements: helpful advice, biological evaluation plans, chemical characterisation, biological testing, toxicity analyses and biological evaluation reports.

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