Current status of ISO 10993-17 and toxicological risk assessment of chemical composition of medical devices

Both ISO 10993-1 and the FDA's application guidelines on ISO 10993-1 highlight the nature of toxicological risk assessment, but there is still a lack of published guidelines for toxicological risk assessment of medical devices. The current version of ISO 10993-17 was revised in 2002. It only describes the derivation of the allowable limit for leachable substances in medical devices, but does not cover the content of toxicological risk assessment. As a result, the ISO TC194 working group (WG 11) is revising ISO 10993-17. The latest supplementary title in the revised version of the standard is "Medical Device Chemical Toxicology Risk Assessment", and its content can also be reset to allow limited determination to extend to medical device chemical toxicology risk assessment.

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