ISO 11607:1997

Packaging for terminally sterilized medical devices ISO 11607:1997

Publication date:   Jan 30, 1997

Scope

Contains the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices whether produced industrially or in health care facilities. Provides guidelines for the most common practices and techniques for the final packaging. The purpose is, to provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package.