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1.1”This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607”’1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.

Product Details

Published:
12/15/2021
Number of Pages:
8
File Size:
1 file , 180 KB
Redline File Size:
2 files , 400 KB
Note:
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