BS EN 1174-1:1996- Sterilization of medical devices. Estimation of the population of micro-organisms on product - Requirements
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1.1 This Part of EN 1174 specifies general criteria to be applied in the estimation of the population of viable
micro-organisms on a medical device or on a component, raw material or package. This estimation
consists of both enumeration and characterization of the population.
1.2 This Part of EN 1174 is not applicable to the enumeration or identification of viral contamination.
1.3 This Part of EN 1174 is not applicable to the microbiological monitoring of the environment in
which medical devices are manufactured (see note 1)-