PREN 17141 : DRAFT 2017
Current
The latest, up-to-date edition.
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
25-07-2017
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Establishment of control requirements
5 Demonstrating control
6 Metrology
7 Training
Annex A (informative) - Guidance for life science
pharma/biopharma 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) - Evolving metrology of
biocontamination control
Annex F (informative) - Guidance on determining
airborne microbiological levels
Annex G (informative) - Guidance on verifying
samplers used for evaluating airborne
microbiological levels
Annex H (informative) - Guidance on determining
microbiological contamination of surfaces
Annex I (informative) - Guidance on determining
microbiological contamination of textiles
Annex J (informative) - Guidance on verifying
laundering processes
Annex K (informative) - Guidance on training
Annex L (informative) - Typical sources of
microbiological contamination
Bibliography
Describes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments.
| Committee |
TC 243
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN 17141:2017-08 (Draft) | Identical |
| NEN EN 17141 : DRAFT 2017 | Identical |
| 17/30329441 DC : 0 | Identical |
| 18/30383200 DC:2018 | Identical |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| EN ISO 14698-1:2003 | Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003) |
| ISO 15161:2001 | Guidelines on the application of ISO 9001:2000 for the food and drink industry |
| ISO 7218:2007 | Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
| 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) |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| 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 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 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| EN 14065:2016 | Textiles - Laundry processed textiles - Biocontamination control system |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| EN 61025:2007 | Fault tree analysis (FTA) |
| EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| 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) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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) |
| 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 |
| EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| ISO 15214:1998 | Microbiology of food and animal feeding stuffs Horizontal method for the enumeration of mesophilic lactic acid bacteria Colony-count technique at 30 degrees C |
| EN ISO 7218 : 2007 COR 2014 | MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS (ISO 7218:2007/AMD 1:2013, CORRECTED VERSION 2014-04-15) |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN ISO 14644-3:2005 | Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005) |
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