I.S. EN 17141:2020
Current
The latest, up-to-date edition.
Cleanrooms and associated controlled environments - Biocontamination control
Hardcopy , PDF
English
30-08-2020
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.
Dates of withdrawal of national standards are available from NSAI.
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
This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments.
| Committee |
CEN/TC 243
|
| DocumentType |
Standard
|
| Pages |
56
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. This standard also refers to PDA TR 33: 2013
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 17141:2020 | Identical |
| BS EN 17141:2020 | Equivalent |
| EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| EN ISO 11290-2:2017 | Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2: Enumeration method (ISO 11290-2:2017) |
| EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| EN ISO 18593:2018 | Microbiology of the food chain - Horizontal methods for surface sampling (ISO 18593:2018) |
| EN ISO 11290-1:2017 | Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method (ISO 11290-1:2017) |
| EN ISO 14644-2:2015 | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015) |
| EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| EN ISO 6579-1:2017 | Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 1: Detection of Salmonella spp. (ISO 6579-1:2017) |
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