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This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. NOTE 2 See Annex A for guidance on Clauses 1 to 9. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. ISO 11737-1:2018 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.