1.1 This guide covers general procedures for conducting controlled tests for determining the integrity of porous barrier medical packages. These procedures are intended to be a guide in determining overall package integrity and are not intended to be used by themselves in determining component material suitability. Material specifications should be written for each component, and a complete battery of tests should be performed to determine its suitability.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.