What are the key biocompatibility testing standards for medical devices?
An example of an AI chatbot conversation about biocompatibility testing standards for medical devices.
What are the key biocompatibility testing standards for medical devices?
The key standards include ISO 10993, which outlines the biological evaluation of medical devices.
Can you explain what ISO 10993 covers?
ISO 10993 covers various tests for assessing the biocompatibility of materials used in medical devices.
What types of tests are included in ISO 10993?
It includes tests for cytotoxicity, sensitization, irritation, and systemic toxicity, among others.
How often should biocompatibility testing be conducted?
Biocompatibility testing should be conducted for each new device or significant design change.
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