ASTM F1980, “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices,” has been updated. The new 2016 Edition is available now from Document Center Inc. You can purchase it online in paper format or for pdf download. A redline version for this standard is also available. The guide provides you with the information you need to evaluate how your medical device’s sterile barrier packaging system holds up over time.
Why do you need to do the assessment provided by ASTM F1980? Many packages for sterile medical devices have an expiration date. This guide shows you how that date should be established.
Do you need to have the medical device inside the package when you test it? Not necessarily. The guideline shows you how to do an accelerated aging evaluation with or without the devices. So if you’re in the process of new product development for example, this standard is still applicable.
When was the last time ASTM F1980 was updated? The last revision was back in 2007. That document was reapproved in 2011. But the new 2016 Edition is a technical update and replaces the earlier edition in full. You’ll need a copy of the new edition if you’re using this standard.
What are the changes are in this new update? For the 2016 Edition, the main changes to this issue are found in Appendix X3. The text portion of this section on relative humidity used in aging protocols has extensive changes. They are marked for your convenience in the redline edition, which is available for a modest increase in price. You can ask our staff for more information by reaching out to us by phone (650-591-7600) or email (info@document-center.com).
Since Document Center Inc. has been an authorized ASTM distributor since the 1980’s, you can search for an order the ASTM standards you need at our webstore, www.document-center.com. Here is a direct link to the order page for the ASTM F1980 for your convenience. And please note: Many obsolete editions of the ASTM standards are available from Document Center Inc. If you can’t find what you’re looking for at the ASTM website, check in with us. We may have the edition you need.
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