Name: PREN 17141 : DRAFT 2017
Brand: CEN

CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL

Published date

07-25-2017

Publisher

Comite Europeen de Normalisation

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 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 ISO 14698-2:2003/AC:2006	CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
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
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