To your question. Is there any need to do biocompatible testing in animals in transvaginal probes which obviously are in contact with the intravaginal mucosa, but not directly because they may have a sheath covering them?
You will need to assess the contact type and duration of every material and component of your transvaginal probe and perform a risk assessment of possible contact and duration as per ISO 10993-1. This will help you identify the type of biocompatibility testing you might need to cover. Please remember that some authorities may have additional biocompatibility requirements. E.g. EU MDR -> assessments of raw materials against CMR 1A or 1B and/or ED phthalates and materials of natural or animal origin, Canada -> BPA, and so on.
Opinion, I would advise taking a look at ISO-10993-2, which would help you analyze if any scientifically valid means can be used to not require animal tests.Hope this helps Andrea
Hope this helps!
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