NEN-EN-ISO 11737-1
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
| Organization: | NEN |
| Publication Date: | 1 February 2018 |
| Status: | active |
| ICS Code (Medical microbiology): | 07.100.10 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
NEN-EN-ISO 11737-1specifies 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. 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. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
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