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Standards Development
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
This document does not apply to the enumeration or characterization of viral, prion or protozoan contaminants. This includes the extraction and detection of the causative agents of transmissible spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 2 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
NOTE 3 ISO/TS 22456 provides specific guidance for bioburden testing for biologics and tissue-based products where this testing is conducted in relation to product sterilization.
This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
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