Testing Standard:
ASTM F1980 Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Standard Number
ASTM F1980
Standard Title
Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Overview:
ASTM F1980 is a guide that provides information for developing accelerated aging protocols to rapidly determine if there are any effects due to the passing of time on a sterile integrity of a sterile barrier system (SBS). Information in this guide can be used to support expiration date claims for medical device sterile barrier systems. Purple Diamond Testing offers ASTM F1980 Testing as part of our packaging compliance and validation services.
Rationale:
ASTM F1980 – Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Its intended use is to observe the loss of the sterile barrier systems integrity which may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time by dynamic events. ASTM F1980 is usually conducted along with seal strength or other qualitative methods for package validation.
Key Points:
- Ages sterile packaging systems to ensure integrity does not degrade
- Guide is used to support expiration date claims
- Use ISO 11607-1 with this test method to set validation standards
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F2097 – Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
Related Testing Standards
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