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  • EN ISO 14644-5 : 2004

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    CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS

    Available format(s): 

    Language(s): 

    Published date:  15-08-2004

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Specification of requirements
    Annex A (informative) Operational systems
    Annex B (informative) Cleanroom clothing
    Annex C (informative) Personnel
    Annex D (informative) Stationary equipment
    Annex E (informative) Materials and portable equipment
    Annex F (informative) Cleanroom cleaning
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 14644-5:2004 specifies basic requirements for cleanroom operations.

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

    Committee TC 243
    Development Note Supersedes ENV 1631. (03/2005)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    BS EN 13824:2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    ISO 13408-1:2008 Aseptic processing of health care products Part 1: General requirements
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    BS EN ISO 13408-1:2015 (published 2015-08) Aseptic processing of health care products General requirements
    VDI 4066 Blatt 4:2016-04 HYGIENE REQUIREMENTS FOR THE PRODUCTION AND FILLING OF DAIRY PRODUCTS WITHOUT RECONTAMINATION
    VDI 2083 Blatt 15:2007-04 CLEANROOM TECHNOLOGY - PERSONNEL AT THE CLEAN WORK PLACE
    VDI 4066 Blatt 1:2013-05 Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 13.2:2009-01 CLEANROOM TECHNOLOGY - QUALITY, PRODUCTION AND DISTRIBUTION OF ULTRAPURE WATER - MICROELECTRONICS AND OTHER TECHNICAL APPLICATIONS
    VDI 2083 Blatt 13.1:2009-01 CLEANROOM TECHNOLOGY - QUALITY, PRODUCTION AND DISTRIBUTION OF ULTRAPURE WATER - FUNDAMENTALS
    VDI 2083 Blatt 4.1:2006-10 CLEANROOM TECHNOLOGY - PLANNING, CONSTRUCTION AND START-UP OF CLEANROOMS
    VDI 2083 Blatt 5.1:2007-09 CLEANROOM TECHNOLOGY - CLEANROOM OPERATION
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS

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

    IEC 61025:2006 Fault tree analysis (FTA)
    IEST RP CC023.1 : 1993 MICROORGANISMS IN CLEANROOMS
    IEST RP CC004.2 : 1992 EVALUATING WIPING MATERIALS USED IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
    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
    EN 1149-1:2006 Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity
    IEST RP CC020.2 : 2002 SUBSTRATES AND FORMS FOR DOCUMENTATION IN CLEANROOMS
    AS 2013.2-1989 Cleanroom garments - Processing and use
    BS 7209:1990 SPECIFICATION FOR WATER VAPOUR PERMEABLE APPAREL FABRICS
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    AS 2013.1-1989 Cleanroom garments - Product requirements
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    IEST RP CC022.1 : 1992 ELECTROSTATIC CHARGE IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
    ISO 11092:2014 Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 7730:2005 Ergonomics of the thermal environment — Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    IEST RP CC026.1 : 1995 CLEANROOM OPERATIONS
    ASTM D 737 : 2004 Test Method for Air Permeability of Textile Fabrics
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