DIN EN ISO 11737-1:2016-11

This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE The nature and extent of microbial characterization is dependent on the intended use of the bioburden data. This part of ISO 11737 does not specify requirements or provide guidance for 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. Guidance on inactivating viruses and prions can be found in ISO 22442-3, 96 ICH Q5A(R1) and ISO 13022. This part of ISO 11737 does not specify requirements or provide guidance for the microbiological monitoring of the environment in which health care products are manufactured.