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.
ISO 18562, has become the industry standard for testing the biocompatibility of breathing components. It has four parts: general principles, evaluation of particle emission, evaluation of volatile gas emission, and evaluation of liquid bourn leachables in condensate. Clin-r+ provides an in-depth breakdown of these four components of the standard.
Biocompatibility and how to apply extractables and leachables to medical devices. ISO 10993 now requires knowledge of any chemicals released by a device while it is in use. This is now included in the testing matrix for each device category. Although materials characterisation isn’t the only way to get this information, it’s the most likely way to discover unexpected materials.
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