ISO/TC 198
| Project No. | ISO/TS 22456:2021 |
|---|---|
| Title | <p><b>1.1.1</b> 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.</p> <p>NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.</p> <p><b>1.1.2</b> Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.</p> |
| Registration number (WIID) | 73256 |
| Scope | <p><b>1.1.1</b> 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.</p> <p>NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.</p> <p><b>1.1.2</b> Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.</p> |
| Status | Standarts spēkā |
| ICS group | 07.100.10 11.080.01 |