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Hello, Sadly not so difficult to find some very recent examples: https://journal.emwa.org/medical-devices-2017/french-breast-implants-the-medical-device-regulation-and-a-theoretical-case-study/article/3087/emwa-26-2-frumento-2.pdf https://www.fda.gov/medical-devices/safety-communications/upda ...

Hello Community, We currently plan bicomp. testing for an upcoming 510(k) submission. According to a device specific standard Leachables testing is expected, e.g. according to ISO 10993-18, and full E&L testing is part of our biocomp. strategy anyway. In a recent 510(k) for a different device ...

Hi, I agree with the TRT based on the upper limit. It is even part of some notified body checklists to proove that the calculation of accelerated aging time is based on the delta between accelerated aging temperature and TRT. However, I am not aware about a standard or formula to conduct this calculation ...

You could reach out to Dennis Brussies from Brussies Life Sciences: http://brussies-ls.com/ ------------------------------ Michael Hottner Köln Germany ------------------------------

Great discussion! I personally have a really strong opinion here: The scope section of ISO 10993-1  clearly defines that the standard applies only to devices with - patient contact during intended use - user's body only if the device is intended for protection. So I would always try to argue that any ...