Validation of Test Methods for Characterizing and Specifying Materials Used in the Construction of Sterilization Packaging

Abstract

This article details the validation of preexisting test methods from EN 868 to enable their adoption into ISO 11607. ISO 11607‐1:2006 specifies the requirements and test methods for packaging materials and barrier systems, which are intended to maintain the sterility of terminally sterilized medical devices until the point of use. To evaluate each method, we conducted a precision experiment as described in ISO 5725‐2. The methods assessed are as follows: water repellency (EN 868 parts 2, 3, 6 and 7), pore size (EN 868 parts 2, 3, 6 and 7), chloride and sulfates content by hot extraction (ISO 9197 and ISO 9198). Copyright © 2012 John Wiley & Sons, Ltd.