Full Description

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.

This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.

This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.