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sklademVydáno: 2021-03-19
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 |
| Vydání: | 1 |
| Vydáno: | 2021-03-19 |
| Počet stran (Anglicky): | 13 |
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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.