Recent changes to ISO 10993-1 have changed the landscape of medical device biological safety testing. The toxicity test box ticking from the biocompatibility test matrix is no longer used. Materials analysis, chemical risk analysis, analytical chemistry, and toxicological risk analysis have all been introduced. Clin-r+ explains what you need to know.
The Toxicological Risk Assessment and Biological Evaluation documentation will undergo significant modifications with the release of the much awaited revisions in this area. Clin-r+ highlights the changes made in 2023 to toxicology and biological evaluation that manufacturers need to be aware of, and what it means for the documentation required to be compliant.
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