What are the regulatory standards for biocompatible materials?

What are the regulatory standards for biocompatible materials?

Regulatory standards for biocompatible materials ensure they are safe for use in medical applications. Key standards include ISO 10993 and ASTM F748.

Can you explain what ISO 10993 covers?

ISO 10993 is a series of standards that evaluate the biocompatibility of medical devices, focusing on their interaction with biological systems.

What tests are included in the ISO 10993 evaluation?

The evaluation includes tests for cytotoxicity, sensitization, irritation, and systemic toxicity, among others.

How often are these standards updated?

These standards are reviewed and updated regularly, typically every few years, to incorporate new research and technological advancements.

Are there any specific regulations for implants?

Yes, implants often have additional regulations, such as those from the FDA in the U.S., which require extensive testing for safety and efficacy.