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ASTM International - ASTM F1980-07

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

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Organization: ASTM International
Publication Date: 1 April 2007
Status: inactive
Page Count: 7
ICS Code (Sterilized packaging): 11.080.30
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.

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 D 4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F 1327 for a definition of "environmental challenging."

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

Document History

December 15, 2021
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as...
September 15, 2016
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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...
August 1, 2011
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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...
ASTM F1980-07
April 1, 2007
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...
January 10, 2002
Standard Guide for Accelerated Aging of Sterile Medical Device Packages
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity...
January 10, 2002
Standard Guide for Accelerated Aging of Sterile Medical Device Packages
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity...
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