• BS EN ISO 14644-4:2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Cleanrooms and associated controlled environments. Design, construction and start-up

    Available format(s):  Hardcopy

    Superseded date:  08-12-2022

    Language(s):  English

    Published date:  15-09-2001

    Publisher:  British Standards Institution

    Add To Cart

    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)

    Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.

    Scope - (Show below) - (Hide below)

    This part of ISO14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.

    NOTE Further guidance in respect of the above requirements is given in annexesA to H. Other parts of ISO14644 may provide complementary information.

    Application of this part of ISO14644 is restricted in the following:

    • user requirements are represented by purchaser or specifier;

    • specific processes to be accommodated in the cleanroom installation are not specified;

    • fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;

    • process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;

    • regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.

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

    Committee LBI/30
    Development Note Supersedes BS 5295-2(1989) & 97/120046 DC (08/2001)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    12/30240811 DC : 0 BS 8568 - CLEANROOM ENERGY - CODE OF PRACTICE FOR IMPROVING ENERGY EFFICIENCY IN CLEANROOMS AND CLEAN AIR DEVICES
    PD 6609:2007 Environmental cleanliness in enclosed spaces. Guide to in situ high efficiency filter leak testing
    BS 8568:2013 Cleanroom energy. Code of practice for improving energy efficiency in cleanrooms and clean air devices
    BS 5N 100-7:2002 Aircraft oxygen systems and equipment Guide to cleaning labelling and packaging

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

    ISO 9004-1:1994 Quality management and quality system elements Part 1: Guidelines
    VDI 2083 Blatt 2:2015-04 Cleanroom technology - Stipulations regarding the checking and monitoring of continued compliance with specifications
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    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 1822-5:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 5: Determining the efficiency of filter elements
    ISO 1940-1:2003 Mechanical vibration Balance quality requirements for rotors in a constant (rigid) state Part 1: Specification and verification of balance tolerances
    EN 779:2012 Particulate air filters for general ventilation - Determination of the filtration performance
    EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
    VDI 2083 Blatt 4:1996-02 Cleanroom technology - Surface cleanliness
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    ISO 14004:2016 Environmental management systems General guidelines on implementation
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 10816-1:1995 Mechanical vibration Evaluation of machine vibration by measurements on non-rotating parts Part 1: General guidelines
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems — Requirements
    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
    EN 1822-3:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 3: Testing flat sheet filter media
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    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)
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    EN 1822-4:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method)
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective