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SRPS EN 17141:2021

Cleanrooms and associated controlled environments - Biocontamination control

Feb 26, 2021

General information

60.60     Feb 26, 2021

ISS

H146

European Norm

13.040.35  

English  

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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WITHDRAWN
SRPS EN ISO 14698-1:2011

WITHDRAWN
SRPS EN ISO 14698-2:2011

NOW

PUBLISHED
SRPS EN 17141:2021
60.60 Standard published
Feb 26, 2021

Related project

Adopted from EN 17141:2020