Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
NORMA vydaná dňa 19.3.2021
Označenie normy: ISO/TS 22456:2021
Dátum vydania normy: 19.3.2021
Počet strán: 13
Približná hmotnosť: 39 g (0.09 libier)
Krajina: Medzinárodná technická norma
Kategória: Technické normy ISO
Description / Abstract: 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.