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View Full Version : Validation of Sterilization Expiry Date - Accelerated Aging, etc s.parakos 19th June 2007, 11:52 PM Hi, Does anybody have any information or know of any relevant documentation (accelerated aging etc) on how to validate the expiry date given to sterilized parts? thanks Simon Stijloor 20th June 2007, 12:06 AM Hi, Does anybody have any information or know of any relevant documentation (accelerated aging etc) on how to validate the expiry date given to sterilized parts? thanks Simon I'm not quite sure, but could this be of any help? http://www.devicelink.com/pmpn/archive/00/01/013.html http://www.devicelink.com/pmpn/archive/07/05/007.html gereard_kgb 20th June 2007, 04:40 AM the links seam to be dead... :( K. Gert Sorensen 20th June 2007, 05:03 AM the links seam to be dead... :( K. Works for me :D Stijloor 20th June 2007, 08:46 AM the links seam to be dead... :( K. I tried the links before posting. Do you have security software preventing you from opening the links? Stijloor. gereard_kgb 20th June 2007, 09:39 AM now it's fine. sorry for the problem. perhaps they were doing something on their server. :notme: Ajit Basrur 20th June 2007, 10:11 AM Hi, Does anybody have any information or know of any relevant documentation (accelerated aging etc) on how to validate the expiry date given to sterilized parts? thanks Simon Hi Simon, There is one ISO document, ISO 11607, Packaging for Terminally Sterilised Medical Devices - sorry I have not gone through it but looks it will contain more details on this subject. Btw, I am attaching 2 documents which might be useful to you - 1. FDA guideline on stability test to support the expiry date for medical gloves. This will give you idea on how to determine the expiry dates, and 2. Millipore Validation Guide |
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