Test compulsory for Sutures?
- Thread starter Christie
- Start date
chris1price
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Have you looked at ISO 10993-18 and performed a risk assessment?
chris1price
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There is also a couple of FDA guidance documents for sutures, these provide advise on biocompatibility testing.
Unless your risk assessment says the test is not needed, then you probably should do it.
Unless your risk assessment says the test is not needed, then you probably should do it.
Are you talking about this?
"Use of ISO 10993-1, Biological evaluation of medical devices - Part 1"
Can you please provide the link of other of FDA guidance documents ?
"Use of ISO 10993-1, Biological evaluation of medical devices - Part 1"
Can you please provide the link of other of FDA guidance documents ?
chris1price
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@chris1price Thank you so much!
