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  • PREN 17141 : DRAFT 2017

    Current The latest, up-to-date edition.

    CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL

    Available format(s): 

    Language(s): 

    Published date:  25-07-2017

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Describes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments.

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee TC 243
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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
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