What are the regulatory requirements for biocompatibility testing?
An example of an AI chatbot conversation about regulatory requirements for biocompatibility testing.
What are the regulatory requirements for biocompatibility testing?
Regulatory requirements for biocompatibility testing vary by region, but generally include ISO 10993 standards.
Can you explain what ISO 10993 entails?
ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices, focusing on biological safety.
What types of tests are included in ISO 10993?
ISO 10993 includes tests for cytotoxicity, sensitization, irritation, and systemic toxicity, among others.
How do I determine which tests are necessary for my device?
The necessary tests depend on the device's intended use, duration of contact with the body, and the materials used.
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