RO
SR EN 17141:2020
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 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 :
Valid
Approval date : 9/30/2020
Number of pages : 52
ICS : 13.040.35 Cleanrooms and associated controlled environments
Technical Committee : 106 - Cleanrooms
- Replaces SR EN ISO 14698-1:2004
- Replaces SR EN ISO 14698-2:2004
- Replaces SR EN ISO 14698-2:2004/AC:2006