SR EN 17141:2020
Camere curate şi medii controlate asociate. Controlul biocontaminării
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.
Status :
In vigoare
Data aprobării : 30.09.2020
Număr de pagini : 52
ICS : 13.040.35 Camere curate si mediu înconjurator controlat
Comitet tehnic : 106 - Camere curate
- Inlocuieste SR EN ISO 14698-1:2004
- Inlocuieste SR EN ISO 14698-2:2004
- Inlocuieste SR EN ISO 14698-2:2004/AC:2006
EN