Accelerated aging of medical device sterile barrier systems by ASTM F1980

ASTM F1980 establishes a standardized approach for accelerated aging testing of medical device sterile barrier systems (SBS), either with or without devices. These studies help manufacturers assess the effects of time, temperature, and other environmental factors on the integrity of the packaging over its expected lifespan.

Aging studies are crucial for many reasons:

Assessment of shelf life: Accelerated aging testing allows manufacturers to predict the shelf life of their medical device packages more rapidly than real-time aging studies. Based on ASTM F1980 test results, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions.

Quality assurance: By conducting accelerated aging testing by ASTM F1980, manufacturers can ensure the quality and integrity of their packaging materials. This helps minimize the risk of package failure during storage, transportation, and use, which is crucial for maintaining the sterility and effectiveness of medical devices.

Compliance: ISO 11607-1 states that shelf life studies need to be performed to demonstrate that an SBS is capable of maintaining sterile barrier integrity through claimed expiration dates. Stability testing using accelerated aging protocols will be considered sufficient evidence for claimed expiry dates until data from real-time aging studies are available. Many regulatory agencies, such as the FDA, will allow products to be approved for sale sooner based on the results of accelerated shelf life studies.

We can also provide real-time stability testing in parallel with accelerated aging studies.

The testing protocol is formulated on a case-by-case basis. You can contact our experts through the form below to get a quote for determining the shelf life of your medical device.