The biocompatibility categories that need to be addressed
Below are the biological effect categories that need to be addressed for a product such as yours which is considered a limited breached or COMPROMISED surface contacting device
This links presented will bring you to pages specific to that biological category of biocompatibility evaluations that are required to be addressed. This does not mean that tests for each category necessarily need to be conducted. But it does mean that they need to be addressed
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