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 medical device, component, raw material or package.
NOTE 1 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 for the enumeration or identification of viral or protozoan contaminants.
NOTE 2 Furthermore, the requirements specified in this part of ISO 11737 are not intended to address the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.