I.S. EN 17141:2020
Current
The latest, up-to-date edition.
Cleanrooms and associated controlled environments - Biocontamination control
Hardcopy , PDF
English
08-30-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Establishment of microbiological control
5 Demonstration of microbiological control
6 Microbiological measurement methods
Annex A (informative) Guidance for life science pharmaceutical and biopharmaceutical applications
Annex B (informative) Guidance for life science medical device applications
Annex C (informative) Guidance for healthcare/hospital applications
Annex D (informative) Guidance for food applications
Annex E (informative) Guidance on culture based microbiological measurement methods and sampler verification
Annex F (informative) Rapid microbiological methods (RMM) and alternative real time microbiological detection methods (AMMs)
Bibliography
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