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EN 17141:2020

Cleanrooms and associated controlled environments - Biocontamination control EN 17141:2020

Publication date:   Nov 17, 2020

General information

60.60 Standard published   Aug 12, 2020

CEN

CEN/TC 243 Cleanroom technology

European Norm

13.040.35   Cleanrooms and associated controlled environments

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14698-2:2003

WITHDRAWN
EN ISO 14698-1:2003

WITHDRAWN
EN ISO 14698-2:2003/AC:2006

NOW

PUBLISHED
EN 17141:2020
60.60 Standard published
Aug 12, 2020