Some additional thoughts Oliver about the text contained in ISO 11607 is the intent of "starting" the accelerated and real time around the same time using similar processes, materials, manufacturing, packaging, and testing methodologies. I could not speak to the exact reasons stated in the standard, but medical devices can go through multiple changes within a short period of time, so doing these together may be important. Myself, I do not interpret accelerated aging can not start before real time, but they are occurring close together or simultaneously. What could be interpreted is accelerated aging testing is used by regulators in lieu of real time to get products on the market because the real time may take a significant amount of time such as 3+ years. What regulators have found too often (which is probably why reflected in the standard) is they do accelerated aging testing and do not complete real time testing or the real time testing is started much, much later. Which sometimes the product under accelerated testing is not representative of the real time testing being performed at a later date. There are many other issues companies do not consider for shelf life/expiration date testing though topic for another thread. Shiven is correct in these should be together or close together. Though I would say it is not just Notified Bodies which look at this closely, many other regulators do as well because products end up with complaints which stem back to design changes/packaging changes and shelf life/expiration date testing is not updated accordingly.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Dec-2022 18:48
From: Shiven Gandhi
Subject: Aging Studies - Accelerated vs Real time aging
Oliver,
Your assessment is correct; Real time (RT) is the mandatory requirement but regulators allow use of Accelerated Aging (AA) in lieu of completing real time studies as real time studies have a longer lead time. My interpretation of the standard is to initiate RT testing within 3 months of starting AA testing. My experience is to build RT and AA devices together (within 3 month windows) and then initiate AA and use that for regulatory purpose while RT testing supplements the AA testing which confirms/validates the AA testing. Notified bodies are more focused on this requirement of having RT testing (building and aging the devices) begin within AA testing than other regulatory agencies.
In my experience, we have built products for AA and then within 3 months built product for RT aging.
Thanks
Shiven
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[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
Original Message:
Sent: 19-Dec-2022 02:52
From: Oliver V.Ruepprecht
Subject: Aging Studies - Accelerated vs Real time aging
Good morning,
We are discussing the order of the ageing studies. According to ISO 11607 section 8.3.4, accelerated ageing must be started within 3 months of Real Time Aging. I know that the real time study is the actual mandatory study, but I would only start such a study when I am reasonably sure that I pass. And I would prove that with the accelerated ageing.
Why is it now required in the standard that accelerated aging may not be started before real time ageing? Or do I see it too strict?
Best Regards
Oliver
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Oliver V.Ruepprecht
Director QA/RA
Augsburg
Germany
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