DIN EN 17141:2021-02
Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
| Fecha edición: |
2021-02-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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. |
| Keywords: | Air pollution|Biocontamination|Checks|Clean rooms|Clean-room technology|Concentration of particles|Contamination|Definitions|Hazards|Medical sciences|Microbiological|Number of particles|Sampling methods|Specification (approval)|Surveillance (approval)|Verification |
| ICS: | 13.040.35 - Salas limpias y ambientes controlados asociados |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 17141:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN 17141:2018-09 Reemplaza a DIN EN ISO 14698-1:2004-04 Reemplaza a DIN EN ISO 14698-2:2004-02 Reemplaza a DIN EN ISO 14698-2 Berichtigung 1:2010-07 |
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