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  • ISO 14644-1:2015

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    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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    08/30184486 DC : DRAFT JUNE 2008 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
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    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
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    DIN EN ISO 14698-1 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
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    BS 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)
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    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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    PREN ISO 14644-2 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
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    DIN EN ISO 1135-5:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
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    BS EN ISO 14698-1:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
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