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EVS-EN 17141:2020

Cleanrooms and associated controlled environments - Biocontamination control

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Kehtiv alates 01.09.2020
Alusdokumendid
EN 17141:2020
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
01.09.2020
Põhitekst
10.12.2004
Põhitekst
10.12.2004
Põhitekst
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.
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CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Uusim versioon Kehtiv alates 03.08.2020
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EVS-EN ISO 14644-14:2016

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Uusim versioon Kehtiv alates 01.11.2016
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EVS-EN ISO 14644-13:2017

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
Uusim versioon Kehtiv alates 16.08.2017