CEN/TC 243/WG 5 - Biocontamination control
Biocontamination control
General Information
Frequently Asked Questions
CEN/TC 243/WG 5 is a Working Group within the European Committee for Standardization (CEN). It is named "Biocontamination control". This committee has published 1 standards.
CEN/TC 243/WG 5 develops CEN standards in the area of Information technology. Currently, there are 1 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.
There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.
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