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sklademVydáno: 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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Označení normy: | ISO/TS 22456:2021 |
Počet stran: | 13 |
Vydání: | 1 |
Vydáno: | 2021 |
Jazyk: | Anglicky |
Počet stran (Anglicky): | 13 |
Popis
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.