Mark Escobedo of WESTPAK offers insights on the revisions made to the latest protocol and how they could affect orthopedic device manufacturers.
The ASTM F1980-21 protocol, titled, “Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices,” recently replaced the F1980-16 version (in December 2021). This procedure is performed to help assess the sterile integrity of a package and product designed for healthcare. The accelerated aging is conducted to validate the Sterile Barrier System for the intended storage shelf life of both the packaging and the product.
In order to avoid any potential confusion as to what impact this change could have on orthopedic device manufacturers, Mark Escobedo, Senior Sales Engineer at WESTPAK Inc., offers a quick rundown of the changes and what they mean for the industry.
