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  • ISO 14644-7:2004

    Current The latest, up-to-date edition.

    Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

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

    Language(s):  English, French

    Published date:  07-10-2004

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.

    The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.

    ISO 14644-7:2004 is not applicable to full-suits.

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

    Committee ISO/TC 209
    Development Note Supersedes ISO/DIS 14644-7 (10/2004)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    DIN EN ISO 29701:2011-01 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
    11/30248115 DC : 0 BS EN ISO 14644-8 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION
    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    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)
    BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
    NF EN ISO 13408-6 : 2011 AMD 1 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
    UNE-EN ISO 14644-8:2014 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
    BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments Vocabulary
    UNE-EN ISO 14644-1:2016 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
    DIN EN ISO 14644-8:2013-06 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    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)
    IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
    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)
    ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
    UNE-EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
    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)
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    AAMI ISO 11737-2 :2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    UNI EN ISO 29701 : 2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    UNI EN ISO 11737-2 : 2010 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    I.S. EN ISO 14644-8:2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION (ACC) (ISO 14644-8:2013)
    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    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 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    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
    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)
    16/30326493 DC : 0 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    BS ISO 15388:2012 Space systems. Contamination and cleanliness control
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 15388:2012 Space systems — Contamination and cleanliness control
    DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
    ISO 14644-8:2013 Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
    BS EN ISO 14644-8:2013 Cleanrooms and associated controlled environments Classification of air cleanliness by chemical concentration (ACC)
    I.S. EN ISO 11737-2:2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    EN ISO 29701 : 2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
    UNI EN ISO 14644-8 : 2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION
    05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    I.S. EN ISO 29701:2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    BS EN ISO 29701:2010 Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
    EN ISO 13408-6:2011/A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
    BS ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
    14/30289934 DC : 0 BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES
    10/30234886 DC : 0 BS ISO 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
    07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    09/30175345 DC : 0 BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
    AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    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)
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    I.S. EN ISO 24998:2008 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)
    ISO 14644-14:2016 Cleanrooms and associated controlled environments Part 14: Assessment of suitability for use of equipment by airborne particle concentration
    EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration
    I.S. EN ISO 14644-1:2015 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    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 14644-14:2016 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
    EN ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    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)
    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)
    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-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)
    ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
    UNE 171340:2012 Validation and evaluation of controlled environment rooms in hospitals
    PREN ISO 14644-8 : DRAFT 2011 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION (ISO/DIS 14644-8:2011)
    UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
    ISO 29701:2010 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    AAMI TIR52:2014(R2022) Environmental monitoring for terminally sterilized healthcare products

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

    EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
    ISO 10648-1:1997 Containment enclosures — Part 1: Design principles
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    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
    EN 12307:1997 Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    BS 3636:1963 Methods for proving the gas tightness of vacuum or pressurized plant
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ENV 1631 : 1996 CLEANROOM TECHNOLOGY - DESIGN, CONSTRUCTION AND OPERATION OF CLEANROOMS AND CLEAR AIR DEVICES
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    EN 12296:1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    IEST RP CC028.1 : 2002
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