ASTM F1980-16 pdf free download.Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
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 harrier systems in whole with or without devices. The sterile harrier 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.
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile harrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a detinilion of “environmental challenging.”
4. Significance and Use
4. 1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
4.2 Iso I 1607—1:2006, clause 6, states that 6’the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile harrier 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.
4.3 Real time aging programs provide the best data to ensure that sterile harrier system materials and sterile harrier system integrity do not degrade over time. 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. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must he carried out to the claimed shelf life ol the product and he performed to their completion.ASTM F1980 pdf download.