GSO ASTM F1980:2021
Gulf Standard
Historical
·
Approved on
01 July 2021
·
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
GSO ASTM F1980:2021 Files
English
7 Pages
Historical
Reference Language
GSO ASTM F1980:2021 Scope
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any,
due to the passage of time on the sterile integrity of the sterile
barrier system (SBS), as defined in ANSI/AAMI/ISO
11607–1:2006 and the physical properties of their component
packaging materials.
1.2 Information obtained using this guide may be used to
support expiration date claims for medical device sterile barrier
systems.
1.3 The accelerated aging guideline addresses the sterile
barrier systems in whole with or without devices. The sterile
barrier system material and device interaction compatibility
that may be required for new product development or the
resulting evaluation is not addressed in this guide.
1.4 Real-time aging protocols are not addressed in this
guide; however, it is essential that real-time aging studies be
performed to confirm the accelerated aging test results using
the same methods of evaluation.
1.5 Methods used for sterile barrier system validation,
which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling,
and shipping events, are beyond the scope of this guide.
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