ISO 10993 (série)
Biological evaluation of medical devices
Series of standards for evaluating the biocompatibility of materials in contact with the body
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Biocompatibility testing by contact type and duration. ISO 10993-1 sets the framework; parts 5, 10 and 11 cover cytotoxicity, irritation and systemic toxicity.
Official sources
https://www.iso.org/standard/68936.htmlSee where this text lands in your roadmap
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