BS EN ISO 11737-1:2018

1   Scope 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. 


    NOTE 2  See Annex A for guidance on Clauses 1 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. 

    NOTE 3  Guidance on inactivating viruses and prions can be found in [ISO 22442-3](/search?q=ISO%C2%A022442-3), ICH Q5A(R1) and [ISO 13022](/search?q=ISO%C2%A013022). 

This document does not apply to the microbiological monitoring of the environment
  in which health care products are manufactured.