ASTM International - ASTM F1980-99e1

Standard Guide for Accelerated Aging of Sterile Medical Device Packages

historical
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Organization: ASTM International
Publication Date: 10 January 2002
Status: historical
Page Count: 6
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 and environmental effects on the sterile integrity of packages 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 packages.

1.3 The accelerated aging guideline addresses the primary medical package in whole and does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.

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 package process validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this guide.

1.6 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

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...
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...
ASTM F1980-99e1
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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