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download between 0-24 hoursReleased: 2021
ISO/TS 22456:2021
ISO/TS 22456:2021-Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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Standard´s number: | ISO/TS 22456:2021 |
Pages: | 13 |
Edition: | 1 |
Released: | 2021 |
Language: | English |
DESCRIPTION
ISO/TS 22456:2021
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.