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  • EN ISO 14644-3:2005

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS

    Available format(s): 

    Superseded date:  23-10-2019

    Language(s): 

    Published date:  15-12-2005

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
      3.1 General
      3.2 Airborne particle measurement
      3.3 Air filters and systems
      3.4 Airflow and other physical states
      3.5 Electrostatic measurement
      3.6 Measuring apparatus and measuring conditions
      3.7 Occupancy states
    4 Test procedures
      4.1 Cleanroom tests
      4.2 Principle
    5 Test reports
    Annex A (informative) Choice of recommended tests of an
            installation and the sequence in which to carry
            them out
    Annex B (informative) Test methods
    Annex C (informative) Test apparatus
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones.

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

    Committee TC 243
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    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)
    BS EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) Classification, performance testing, marking
    DIN EN 1822-1:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    17/30358936 DC : 0 BS EN 1822-1 - HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    I.S. EN 1822-1:2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    VDI 3803 Blatt 4:2012-09 Air-conditioning, system requirements - Air filter systems (VDI Ventilation Code of Practice)
    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 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
    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 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    UNI EN 1822-1 : 2010 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    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
    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)
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    PREN 1822-1 : DRAFT 2017 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    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
    UNE-EN 1822-1:2010 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals

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

    ISO 5167-3:2003 Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 3: Nozzles and Venturi nozzles
    IEST RP CC007.1 : 1992 TESTING ULPA FILTERS
    ASTM F 328 : 1998 Standard Practice for Calibration of an Airborne Particle Counter Using Monodisperse Spherical Particles
    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 RP CC006.3 : 2004 TESTING CLEANROOMS
    EN 12599:2012 Ventilation for buildings - Test procedures and measurement methods to hand over air conditioning and ventilation systems
    ISO 7726:1998 Ergonomics of the thermal environment Instruments for measuring physical quantities
    ISO 5167-4:2003 Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 4: Venturi tubes
    SEMI E14 : 1993 MEASUREMENT OF PARTICLE CONTAMINATION CONTRIBUTED TO THE PRODUCT FROM THE PROCESS OR SUPPORT TOOL
    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 5167-2:2003 Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 2: Orifice plates
    IEST RP CC021.1 : 1992 TESTING HEPA AND ULPA FILTER MEDIA
    IEST G CC1001 : 1999 COUNTING AIRBORNE PARTICLES FOR CLASSIFICATION AND MONITORING OF CLEANROOMS AND CLEAN ZONES
    ISO 5167-1:2003 Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 1: General principles and requirements
    IEST G CC1003 : 1999 MEASUREMENT OF AIRBORNE MACROPARTICLES
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    IEST G CC1002 : 1999 DETERMINATION OF THE CONCENTRATION OF AIRBORNE ULTRAFINE PARTICLES
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    IEST RP CC001.3 : 1993 HEPA AND ULPA FILTERS
    EN 1822-4:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method)
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