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CEN - EN 17141

Cleanrooms and associated controlled environments - Biocontamination control

active, Most Current
Organization: CEN
Publication Date: 1 August 2020
Status: active
Page Count: 54
ICS Code (Cleanrooms and associated controlled environments): 13.040.35
scope:

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.

Document History

EN 17141
August 1, 2020
Cleanrooms and associated controlled environments - Biocontamination control
This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for...

References

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