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  • DIN EN ISO 14644-4:2003-06

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-04-2023

    Language(s):  English, German

    Published date:  01-06-2003

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Planning and design
      5.1 Planning procedure
      5.2 Design
    6 Construction and start-up
    7 Testing and approval
      7.1 General
      7.2 Construction approval
      7.3 Functional approval
      7.4 Operational approval
    8 Documentation
      8.1 General
      8.2 Record of an installation
      8.3 Operational instructions
      8.4 Instructions for performance monitoring
      8.5 Maintenance instructions
      8.6 Maintenance record
      8.7 Record of operation and maintenance training
    Annex A (informative) Control and segregation concepts
    Annex B (informative) Classification examples
    Annex C (informative) Approval of an installation
    Annex D (informative) Layout of an installation
    Annex E (informative) Construction and materials
    Annex F (informative) Environmental control of cleanrooms
    Annex G (informative) Control of air cleanliness
    Annex H (informative) Additional specification of
            requirements to be agreed upon between
            purchaser/user and designer/supplier
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 406. Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.

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

    Document Type Standard
    Product Note THIS STANDARD REFERS TO : ISO 14698-3
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN HDBK 406 : 2ED 2016
    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)
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    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 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 12:2000-01 Cleanroom technology - Safety and environmental aspects
    DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
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