ISO/TC 198
| Projekta Nr. | ISO/TS 22456:2021 |
|---|---|
| Nosaukums | <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> |
| Reģistrācijas numurs (WIID) | 73256 |
| Darbības sfēra | <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> |
| Statuss | Standarts spēkā |
| ICS grupa | 07.100.10 11.080.01 |