1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.
NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.
1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.
Status: PublishedPublication date: 2021-03
Edition: 1Number of pages: 13
Technical Committee: ISO/TC 198 Sterilization of health care products
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