Status
Gældende
Type
Standard
Varenummer
M316126
Udgivelsesdato
2020-08-19
Komite
CEN/TC 243
International arbejdsgruppe WG
CEN/TC 243
Internationale relationer
EN 17141:2020 IDT
Dansk udvalg
Antal sider
51
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.