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    ISO 14644-3:2005

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
    View superseded by

    Cleanrooms and associated controlled environments Part 3: Test methods

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

    Withdrawn date:  31-08-2019

    Language(s):  English, French

    Published date:  06-12-2005

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational.

    ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

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

    Development Note DRAFT ISO/DIS 14644-3 is also available for this standard. (08/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    ISO 29463-1:2017 High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
    UNE-EN ISO 16170:2017 In situ test methods for high efficiency filter systems in industrial facilities (ISO 16170:2016, Corrected version 2017-04)
    BS EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) Classification, performance testing, marking
    09/30182875 DC : 0 BS ISO 29463-4 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 4: TEST METHOD FOR DETERMINING THE LEAKAGE OF FILTER ELEMENTS (SCAN METHOD)
    BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
    I.S. EN ISO 16170:2016 IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016, CORRECTED VERSION 2017-04)
    18/30333968 DC : 0 BS ISO 8573-4 - COMPRESSED AIR - CONTAMINANT MEASUREMENT - PART 4: PARTICLE CONTENT
    AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    S.R. CEN ISO TS 27687:2009 NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE
    AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    DIN EN ISO 16170:2013-07 (Draft) IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016)
    ASTM E 2217 : 2012 : REDLINE Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
    BS EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) Aerosol production, measuring equipment, particle counting statistics
    BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments Vocabulary
    BS EN ISO 29462:2013 Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow
    BS EN ISO 16890-2:2016 Air filters for general ventilation Measurement of fractional efficiency and air flow resistance
    UNE-EN ISO 16890-2:2017 Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016)
    15/30278074 DC : 0 BS EN ISO 16890-3 - AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    UNE-EN ISO 16890-3:2017 Air filters for general ventilation - Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured (ISO 16890-3:2016)
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    CEN ISO/TS 27687:2009 Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008, Corrected version 2009-02-01)
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    UNI EN ISO 29461-1 : 2013 AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS
    NBR ISO 14644-2 : 2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR TESTING AND MONITORING TO PROVE CONTINUED COMPLIANCE WITH ABNT NBR ISO 14644-1
    ONORM EN ISO 29462 : 2013 FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW (ISO 29462:2013)
    IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
    12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
    I.S. EN ISO 16890-3:2016 AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016)
    I.S. EN ISO 16890-2:2016 AIR FILTERS FOR GENERAL VENTILATION - PART 2: MEASUREMENT OF FRACTIONAL EFFICIENCY AND AIR FLOW RESISTANCE (ISO 16890-2:2016)
    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
    PD CEN ISO/TS 27687:2009 Nanotechnologies. Terminology and definitions for nano-objects. Nanoparticle, nanofibre and nanoplate
    09/30182865 DC : 0 BS ISO 29463-1 - HIGH EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 1: CLASSIFICATION, PERFORMANCE, TESTING AND MARKING
    BS ISO 15378 : 2006 AMD 17315 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    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)
    DIN EN 1822-1:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
    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
    UNI EN 1822-1 : 2010 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    ISO 29463-3:2011 High-efficiency filters and filter media for removing particles in air — Part 3: Testing flat sheet filter media
    EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
    I.S. EN 1822-2:2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS
    I.S. EN 1822-1:2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    DIN EN ISO 16890-3:2015-08 (Draft) AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016)
    DIN EN ISO 29462:2013-11 Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013)
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    DD ISO/TS 21220:2009 Particulate air filters for general ventilation. Determination of filtration performance
    BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up
    BS EN ISO 16890-3:2016 Air filters for general ventilation Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured
    UNE-EN ISO 29462:2014 Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013)
    I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    VDI 3803 Blatt 4:2012-09 Air-conditioning, system requirements - Air filter systems (VDI Ventilation Code of Practice)
    DIN EN ISO 16890-3:2017-08 AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016)
    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
    DIN EN ISO 16170:2017-05 IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016)
    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 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    UNE-EN ISO 14644-14:2017 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
    AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    08/30176845 DC : DRAFT APR 2008 BS EN 1822-2 - HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTIC
    DIN EN ISO 16170 E : 2017 IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016)
    14/30280736 DC : 0 BS EN ISO 14644-14 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 14 ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT BY AIRBORNE PARTICLE CONCENTRATION
    10/30152881 DC : DRAFT DEC 2010 BS EN ISO 14644-2 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
    ISO 16170:2016 In situ test methods for high efficiency filter systems in industrial facilities
    BS ISO 15388:2012 Space systems. Contamination and cleanliness control
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    DD CEN ISO/TS 27687 : 2009 NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE
    01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ISO 29463-2:2011 High-efficiency filters and filter media for removing particles in air — Part 2: Aerosol production, measuring equipment and particle-counting statistics
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    UNE-EN 1822-1:2010 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    ISO 12500-1:2007 Filters for compressed air Test methods Part 1: Oil aerosols
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    ISO 29463-4:2011 High-efficiency filters and filter media for removing particles in air — Part 4: Test method for determining leakage of filter elements-Scan method
    DIN EN 1822-2:2011-01 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS
    UNE-EN 1822-2:2010 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
    UNI EN 1822-2 : 2010 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS
    ISO 15388:2012 Space systems — Contamination and cleanliness control
    DIN EN ISO 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    DIN EN ISO 14644-2:2016-05 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)
    DIN EN ISO 16890-2 E : 2017 AIR FILTERS FOR GENERAL VENTILATION - PART 2: MEASUREMENT OF FRACTIONAL EFFICIENCY AND AIR FLOW RESISTANCE (ISO 16890-2:2016)
    DIN EN ISO 29461-1:2014-03 Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013)
    UNE-EN ISO 14644-2:2016 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)
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    DIN EN ISO 16890-2:2017-08 Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016)
    I.S. EN ISO 15883-1:2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    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)
    I.S. EN ISO 29462:2013 FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW (ISO 29462:2013)
    UNI EN ISO 15883-1 : 2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    UNI CEN ISO/TS 27687 : 2010 NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE
    ISO 29461-1:2013 Air intake filter systems for rotary machinery Test methods Part 1: Static filter elements
    UNI EN ISO 29462 : 2013 FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW
    09/30182871 DC : 0 BS ISO 29463-3 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 3: TEST METHOD FOR FLAT SHEET FILTER MEDIA
    BS EN ISO 16170:2016 In situ test methods for high efficiency filter systems in industrial facilities
    09/30182868 DC : 0 BS ISO 29463-2 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT AND PARTICLE-COUNTING STATISTICS
    05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    09/30182882 DC : 0 BS ISO 29463-5 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 5: TEST METHOD FOR DETERMINING THE EFFICIENCY OF FILTER ELEMENTS
    BS ISO 12500-1:2007 Filters for compressed air. Test methods Oil aerosols
    DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    16/30348371 DC : 0 BS ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: SPECIFICATIONS FOR MONITORING AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION
    10/30234886 DC : 0 BS ISO 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
    01/122934 DC : DRAFT AUG 2001 BS EN ISO 14644-5 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS
    07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    PD CEN ISO/TS 80004-2:2017 Nanotechnologies. Vocabulary Nano-objects
    08/30176838 DC : DRAFT APR 2008 BS EN 1822-1 - 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
    AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    DIN CEN ISO/TS 27687:2008-11 NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE
    UNE-EN ISO 15378:2016 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
    UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    I.S. EN ISO 14644-14:2016 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 14: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT BY AIRBORNE PARTICLE CONCENTRATION (ISO/DIS 14644-14)
    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 24998:2008 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    ISO 29463-5:2011 High-efficiency filters and filter media for removing particles in air Part 5: Test method for filter elements
    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)
    UNE-EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
    EN 1822-2 : 2019 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS
    ISO/TS 80004-2:2015 Nanotechnologies — Vocabulary — Part 2: Nano-objects
    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 16890-2:2016 Air filters for general ventilation — Part 2: Measurement of fractional efficiency and air flow resistance
    BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments Operations
    ISO 16890-3:2016 Air filters for general ventilation Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 14644-14:2016 Cleanrooms and associated controlled environments Part 14: Assessment of suitability for use of equipment by airborne particle concentration
    07/30113225 DC : 0 BS ISO 21220 - PARTICULATE AIR FILTERS FOR GENERAL VENTILATION - DETERMINATION OF THE FILTRATION PERFORMANCE
    ISO/TS 21220:2009 Particulate air filters for general ventilation Determination of filtration performance
    UNE-EN ISO 29461-1:2014 Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013)
    UNE-CEN ISO/TS 27687:2010 Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008)
    10/30211683 DC : 0 BS EN ISO 29461-1 - AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS
    ISO/TS 27687:2008 Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate
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    BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    I.S. 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)
    BS EN ISO 15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    EN ISO 16890-2:2016 Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016)
    EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    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 24998:2008 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008)
    EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    EN ISO 14644-14:2016 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
    EN ISO 16890-3:2016 Air filters for general ventilation - Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured (ISO 16890-3:2016)
    EN ISO 29462:2013 Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013)
    EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    13/30248319 DC : 0 BS EN ISO 16170 - IN SITU TEST METHODS FOR VERY HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES
    13/30261893 DC : 0 BS EN ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: CLASSIFICATION OF AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION
    14/30287226 DC : 0 BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    PREN 1822-1 : DRAFT 2017 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    BS EN ISO 14644-14:2016 ENISO 14644-14 environments — Assessment of suitability of equipment and materials for cleanrooms Assessment of suitability for use of equipment by airborne particle concentration
    17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    UNE 171340:2012 Validation and evaluation of controlled environment rooms in hospitals
    CEN/TS 16244:2018 Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    S.R. CEN ISO/TS 80004-2:2017 NANOTECHNOLOGIES - VOCABULARY - PART 2: NANO-OBJECTS (ISO/TS 80004-2:2015)
    UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    I.S. EN ISO 15378:2017 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
    DIN EN ISO 15883-1:2014-10 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
    EN ISO 29461-1:2013 Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013)
    BS EN ISO 29461-1:2013 Air intake filter systems for rotary machinery. Test methods Static filter elements
    ISO 29462:2013 Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow
    I.S. EN ISO 29461-1:2013 AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS (ISO 29461-1:2013)
    EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
    CEN ISO/TS 80004-2:2017 Nanotechnologies - Vocabulary - Part 2: Nano-objects (ISO/TS 80004-2:2015)
    DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

    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
    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
    ISO 14644-2:2000 Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
    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
    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)
    ISO 14644-1:1999 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness
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