0

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 ISO/TS 22456:2021

Publication date:   Mar 19, 2021

General information

90.20 Standard under periodical review   Jan 15, 2024

ISO

ISO/TC 198 Sterilization of health care products

Technical Specification

11.080.01   Sterilization and disinfection in general | 07.100.10   Medical microbiology

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

NOW

PUBLISHED
ISO/TS 22456:2021
90.20 Standard under periodical review
Jan 15, 2024