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

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.

OEN:

ISO

Langue:

English

Code(s) de l'ICS:

07.100.10; 11.080.01

Statut:

Publié

Date de Publication:

2021-03-18

Numéro Standard:

ISO/TS 22456:2021