BS EN ISO 11737-1:2018+A1:2021現行
Sterilization of health care products. Microbiological methods Determination of a population of microorganisms on products
出版：British Standards Institution
專家解讀視頻
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. NOTE1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE2 See AnnexA for guidance on Clauses1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE3 Guidance on inactivating viruses and prions can be found in ISO22442?3, ICHQ5A(R1) and ISO13022. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
