ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

This guide provides information for developing accelerated aging protocols to rapidly identify 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.

Information obtained using this guide can be used to support expiration date requests for medical device sterile barrier systems.

The accelerated aging guideline addresses sterile barrier systems with or without devices as a whole. Sterile barrier system material and device interaction compatibility that may be required for new product development or eventual evaluation are not covered in this guide.

Real-time aging protocols are not covered in this guide; however, real-time aging studies are essential to validate accelerated aging test results using the same evaluation methods.

Methods used for sterile barrier system verification, including the machine process, the effects of the sterilization process, environmental challenges, distribution, handling and shipping events are beyond the scope of this guide.

This guide does not address environmental challenges that warn of extreme climatic conditions that can be found in the shipping and handling environment. See Application D4332 for standard conditions that can be used to force the sterile barrier system to realistic extremes in temperature and humidity conditions.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

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