Laboratory analysis and accelerated aging tests on sterile packaging in accordance with the ASTM F1980 standard
Your needs : to analyze the sterile packaging of your medical devices
Why analyze the sterile packaging of your medical devices ?
Medical devices are subject to very stringent standards in terms of production, cleaning, biocompatibility and in they way they are stored and packaged. The ISO 11607 standard specifies that medical device packaging must provide physical protection forming a sterile barrier until the device is used or until it reaches its expiration date.
Due to this, it is mandatory in the field of medical devices to analyze sterile packaging. FILAB laboratory is able to carry out such testing according to the terms of the ASTM F1980 standard.
Our solution : to analyze sterile packaging in accordance with the ASTM F1980 standard
Analytical techniques relating to the ASTM F1980 standard
The ASTM F1980 standard specifies the conditions for analyzing the aging process of sterile packaging. The sterile barrier it forms is subjected to accelerated aging tests. We are able to simulate realistic storage conditions and carry out various physical and mechanical in accordance with the ASTM F1980 standard.
Why call on FILAB to analyze sterile packaging in accordance with the ASTM F1980 standard ?
Our specialists know that each type of medical device requires specific preparation to be tested in accordance with the ASTM F1980 standard. This is why we clearly define the aging conditions we apply to your device during testing so that the results we obtain can be reliable and true to the real storage conditions of your product.
