Biocompatibility FAQ
What is biocompatibility for a medical device?
Why is it needed? What does it do?
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biocompatibility
ISO 18562 – Biocompatibility evaluation
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
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.
