planB
Super Moderator
Mixi,
in addition to ISO 10993-1:2018, have a look into the FDA guidance on biocompatibility. Specifically on p. 8, this guidance says - quote
A note on "putting test results into perspective"; this is typically and evaluation activity that either you would do or a consulting division formally independent from the test lab: an accredited test lab is exceeding its scope if they interpreted the test results, so they typically don't.
HTH,
Gerhard (from Austria)
in addition to ISO 10993-1:2018, have a look into the FDA guidance on biocompatibility. Specifically on p. 8, this guidance says - quote
In certain situations, a sponsor may propose to use a material that has known toxicities but where the material could be acceptable for the end use. In this case, the risk assessment should include consideration of the intended use population that will use (e.g., protective mask for clinician) or be treated with the device and a discussion of potential benefits of using the chosen material as well as potential mitigations that have been considered (e.g., hermetically sealing).
A chemical analysis of the materials used in a device in its final finished form can be informative. Chemical analysis can be particularly helpful to demonstrate that chemical toxicity testing from a previously cleared or approved medical device is relevant to a device under review by the Agency. For example, in some circumstances, a chemical analysis can demonstrate that the extractables and leachables in a biocompatibility extract have not changed, eliminating the need for additional biocompatibility testing using that type of solvent.
A note on "putting test results into perspective"; this is typically and evaluation activity that either you would do or a consulting division formally independent from the test lab: an accredited test lab is exceeding its scope if they interpreted the test results, so they typically don't.
HTH,
Gerhard (from Austria)