This ASTM F1980 accelerated aging standard of sterile barrier packaging for medical devices specification 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). ASTM F1980 is also applicable to the physical properties of their component packaging materials.
Information obtained using this ASTM F1980 specification may be used to support expiration date claims for medical device sterile barrier systems. The accelerated aging ASTM F1980 specification addresses the sterile barrier systems in whole with or without devices. It is essential that real-time aging studies be performed to confirm the accelerated aging ASTM F1980 test results using the same methods of evaluation. Conservative accelerated aging factors (AAFs) must be used to complement the ASTM F1980 specification if little is known about the sterile barrier system material being evaluated. A reference to Practice D4332 for standard conditions may be used in addition to this ASTM F1980 specification to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
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