Hi there,
Did anybody ever test biocompatibility specifically on aged devices? Iso 10993-1 does not say anything about that, however the question came up during our shelf-life Evaluation and i am considering doing it (e.g. initially a chemical characterization of both aged and non-aged device and then compare leachables profile. Then, if significantly different leachables profile conduct biological testing).
One question that comes up now is if accelarated aging would be appopriate, or if we would have to use real-time aged products (end of shelf life).
Thanks
Freddo
Did anybody ever test biocompatibility specifically on aged devices? Iso 10993-1 does not say anything about that, however the question came up during our shelf-life Evaluation and i am considering doing it (e.g. initially a chemical characterization of both aged and non-aged device and then compare leachables profile. Then, if significantly different leachables profile conduct biological testing).
One question that comes up now is if accelarated aging would be appopriate, or if we would have to use real-time aged products (end of shelf life).
Thanks
Freddo