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 Inclusions
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.
1.2 Exclusions 1.2.1 This document does not include guidance for validation requirements for testing, eliminating and/or inactivating viruses and prions or sterilization of tissue-based products.
NOTE Guidance on inactivating viruses and prions can be found in ISO 22442-3.
1.2.2 This document does not include guidance for containment or biosafety issues for biologics and tissue-based products.
1.2.3 This document does not include guidance for testing biologics and tissue-based products for specific infectious agents as listed in relevant national or international guidance (e.g. viruses/protozoa/ parasites, intracellular microorganisms or mycoplasma screening).
1.2.4 This document does not include guidance for the acceptance criteria for biologics and tissue- based products during procurement or tissue to be processed and/or released for use. 1.2.5 This document does not include guidance for the testing associated with procurement and screening of biologics and tissue-based products.
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