ASTM F1980 Accelerated Aging Medical Devices

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:

Related Standards:

Accreditations

Achieving ISO 17025 Accreditation is the pinnacle in third-party laboratory testing accreditation. It confirms that the facility has management, quality, and technical systems in place to ensure accurate and reliable analyses.
ISTA is revered as the certification standard for package testing for distribution. ISTA’s Testing Protocol remains a series of testing methodologies and standards well recognized within the packaging community.
A select few companies are authorized by PHMSA as an approved third-party packaging testing laboratory in accordance with Hazardous Materials Regulations, critical to ensuring safe transport of dangerous goods.

Affiliations

With over 12,000 standards globally, ASTM International’s fully transparent standards development enhances performance and confidence in consumer choices.
The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

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