• ISO 14644-1:2015

    Current The latest, up-to-date edition.

    Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  09-12-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 146447.

    Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 m to 5 m are considered for classification purposes.

    The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.

    ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 m to 5 m. Concentrations of ultrafine particles (particles smaller than 0,1 m) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 m).

    ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

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

    Committee ISO/TC 209
    Development Note Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-1. (12/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

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    ISO 12345:2013 Diesel engines Cleanliness assessment of fuel injection equipment
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    IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
    13/30261893 DC : 0 BS EN ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: CLASSIFICATION OF AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION
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    PD CEN ISO/TS 80004-6:2015 NANOTECHNOLOGIES - VOCABULARY - PART 6: NANO-OBJECT CHARACTERIZATION
    10/30207686 DC : DRAFT DEC 2010 BS ISO 12345 - DIESEL ENGINES - CLEANLINESS ASSESSMENT OF FUEL INJECTION EQUIPMENT
    BS EN ISO 5667-23 : 2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
    BS PD IEC TR 62258-3 : 2005 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
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    BS EN 16442 : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
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    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
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    AES 49 : 2005(R2010)
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    BS EN ISO 29701 : 2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
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    VDI/VDE 3516-2 : 1981 VALIDATION IN THE GXP AREA - SMALL MANUFACTURING AND TESTING DEVICES
    UNI EN ISO 5667-23 : 2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
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    16/30295652 DC : 0 BS EN ISO 14644-15 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 15: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT AND MATERIALS BY AIRBORNE CHEMICAL AND SURFACE CHEMICAL CONCENTRATION
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    AAMI TIR52 : 2014 : R2017 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
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    DIN EN ISO 1135-3 E : 2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
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    VDI 2083-3 : 2005 CLEANROOM TECHNOLOGY - METROLOGY AND TEST METHODS
    13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
    ASTM E 2311 : 2004 : R2009 Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space
    BS ISO 15388:2012 Space systems. Contamination and cleanliness control
    DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
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    DD CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
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    S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
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