More F The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective.
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Sign Up Below! The new 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. 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.
The last revision was back in That document was reapproved in But the new Edition is a technical update and replaces the earlier edition in full. What are the changes are in this new update? For the Edition, the main changes to this issue are found in Appendix X3. 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 or email info document-center.
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ASTM F1980 2016 Medical Device Packaging
ASTM F1980 – 医療用滅菌バリアシステムの加速老化標準ガイド