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.
Status: WithdrawnPublication date: 1997-01
Edition: 1Number of pages: 18
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.30 Sterilized packaging
ISO 11607:1997Stage: 95.99
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