ASTM F1980-07
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Standard No.

ASTM F1980-07

Release Date

2007

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F1980-07(2011)

Latest

ASTM F1980-21

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.

ASTM F1980-07 Referenced Document

• ASTM D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• ASTM E337 Standard Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
• ASTM F1327 Standard Terminology Relating to Barrier Materials for Medical Packaging
• ASTM F17 Standard Terminology Relating to Flexible Barrier Materials
• ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM F1980-07 history

• 2021 ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
• 2016 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• 2007 ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• 2007 ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• 2002 ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
• 2002 ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages