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Details steps necessary to assess compatibility of health care product and packaging materials with radiation sterilization processes. Guidance is provided on selecting appropriate materials, choosing processing protocols that optimize product performance, and material testing as part of a qualification program. An extensive review of accelerated aging techniques is also included. Companion document to ANSI/AAMI/ISO 11137:1994.
Product Details
- Published:
- 10/01/1998
- Number of Pages:
- 55
- File Size:
- 1 file , 430 KB