ISO/TS 22456:2021 保健产品的灭菌 微生物学方法 生物制剂和组织基产品的生物负荷测定和无菌性试验指南

标准编号：ISO/TS 22456:2021

中文名称：保健产品的灭菌 微生物学方法 生物制剂和组织基产品的生物负荷测定和无菌性试验指南

英文名称：Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

发布日期：2021-03

标准范围

1.1.1本文件为生物制剂和基于组织的产品的生物负载试验和无菌试验提供了指导，其中该试验与产品灭菌有关。注:本文件旨在与ISO 11737-1和ISO 11737-2结合使用。1.1.2本文件中的指导原则可适用于非无菌但受微生物控制的生物制剂和基于组织的产品。

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.

标准预览图