What are the regulations for biocompatibility testing?

What are the regulations for biocompatibility testing?

Biocompatibility testing regulations ensure that medical devices are safe for human use. They vary by region, with key guidelines from ISO 10993 and FDA.

Can you explain ISO 10993?

ISO 10993 is a series of international standards for evaluating the biocompatibility of medical devices. It covers various tests to assess the biological response.

What types of tests are included in ISO 10993?

ISO 10993 includes tests for cytotoxicity, sensitization, irritation, and systemic toxicity, among others, to evaluate safety.

How do these regulations differ between the US and Europe?

In the US, the FDA regulates biocompatibility testing, while in Europe, the MDR (Medical Device Regulation) applies, which may have different requirements.

What happens if a device fails biocompatibility testing?

If a device fails biocompatibility testing, it cannot be marketed until the issues are resolved, which may involve redesign or additional testing.