Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products
Specifies general criteria for the estimation of the population of viable microorganisms on medical devices or packages. Not applicable for the enumeration or identification of viral contamination and to the microbiological monitoring of the environment in which medical devices are manufactured.
A standard is reviewed every 5 years
Revisions / Corrigenda