• EN 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 (ISO 14644-1:2015)

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    Published date:  23-12-2015

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Demonstration of compliance
    Annex A (normative) - Reference method for classification
            of air cleanliness by particle concentration
    Annex B (informative) - Examples of classification
            calculations
    Annex C (informative) - Counting and sizing of airborne
            macroparticles
    Annex D (informative) - Sequential sampling procedure
    Annex E (informative) - Specification of intermediate decimal
            cleanliness classes and particle size thresholds
    Annex F (informative) - Test instruments
    Bibliography

    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 14644‑7.Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm 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 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) 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 µm).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 CEN/TC 243
    Development Note Supersedes PREN ISO 14644-1. (01/2016)
    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
    DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    I.S. EN 62258-1:2010 SEMICONDUCTOR DIE PRODUCTS - PART 1: PROCUREMENT AND USE
    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
    CLC/TR 62258-3:2007 Semiconductor die products - Part 3: Recommendations for good practice in handling, packing and storage
    EN 62258-1:2010 Semiconductor die products - Part 1: Procurement and use
    BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    PD CLC/TR 62258-3:2007 Semiconductor die products Recommendations for good practice in handling, packing and storage
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    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)
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up
    I.S. EN ISO 1135-4:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    I.S. EN 131-2:2010 LADDERS - PART 2: REQUIREMENTS, TESTING, MARKING
    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    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 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
    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/VDE 2627 Blatt 1:2015-12 Measuring rooms - Classification and characteristics - Planning and execution
    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 3455:2013-08 Emission control - High-volume car body painting plants
    VDI/VDE 3516 Blatt 2:1981-07 Process analytical equipment for fluids
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    VDI 2119:2013-06 Ambient air measurements - Sampling of atmospheric particles > 2,5 ?m on an acceptor surface using the Sigma-2 passive sampler - Characterisation by optical microscopy and calculation of number settling rate and mass concentration
    I.S. CLC/TR 62258-3:2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    09/30176561 DC : 0 BS EN ISO 5667 - WATER QUALITY - SAMPLING - PART 23: DETERMINATION OF PRIORITY POLLUTANTS IN SURFACE WATER USING PASSIVE SAMPLING
    UNE-EN 16372:2015 Aesthetic surgery services
    12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    BS EN ISO 11551:2003 Optics and optical instruments. Lasers and laser-related equipment. Test method for absorptance of optical laser components
    I.S. EN 14777:2004 SPACE ENGINEERING - MULTIPACTION DESIGN AND TEST
    DIN EN ISO 1135-3 E : 2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    BS EN 62258-1:2010 Semiconductor die products Procurement and use
    DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    S.R. CEN/TS 16244:2018 VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
    UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
    ISO 11551:2003 Optics and optical instruments Lasers and laser-related equipment Test method for absorptance of optical laser components
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    BS EN 131-2 : 2010 LADDERS - PART 2: REQUIREMENTS, TESTING, MARKING
    BS EN ISO 13696:2002 Optics and optical instruments. Test methods for radiation scattered by optical components
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    EN 14777:2004 Space engineering - Multipaction design and test
    EN 16372:2014 Aesthetic surgery services
    EN ISO 11551:2003 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components (ISO 11551:2003)
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    BS EN 16372:2014 Aesthetic surgery services
    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
    CEN/TS 16244:2018 Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    CEI CLC/TR 62258-3 : 2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    BS EN 14777:2004 Space engineering. Multipaction design and test
    CEI EN 62258-1 : 2011 SEMICONDUCTOR DIE PRODUCTS - PART 1: PROCUREMENT AND USE
    EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    EN 131-2:2010+A2:2017 Ladders - Part 2: Requirements, testing, marking

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

    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
    IEST G CC1004 : 1999 SEQUENTIAL-SAMPLING PLAN FOR USE IN CLASSIFICATION OF THE PARTICULATE CLEANLINESS OF AIR IN CLEANROOMS AND CLEAN ZONES
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    IEST G CC1003 : 1999 MEASUREMENT OF AIRBORNE MACROPARTICLES
    ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces
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