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17/30329441 DC : 0

NA

NA

Status of Standard is Unknown

BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL

Available format(s)

Hardcopy , PDF

Language(s)

English

€23.37
Excluding VAT

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

BS EN 17141.

Committee
LBI/30
DocumentType
Draft
Pages
77
PublisherName
British Standards Institution
Status
NA

Standards Relationship
PREN 17141 : DRAFT 2017 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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