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  • ISO 14644-8:2013

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)

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

    Withdrawn date:  21-06-2022

    Language(s):  French, English

    Published date:  18-02-2013

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14644-8:2013 establishes the classification of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.

    ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 1012 g/m3 under cleanroom operational conditions.

    ISO 14644-8:2013 is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.

    It is not the intention of ISO 14644-8:2013 to describe the nature of air chemical contaminants.

    ISO 14644-8:2013 does not give a classification of surface chemical contamination.

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

    Development Note Supersedes ISO/DIS 14644-8. (02/2013)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS ISO 14698 , IEST-G-CC035, ASTM D5127-99, SEMI E108-0307, IEST-RP-CC031.2, JIS B9917-8:2010, SEMI E45-1101,SEMI E460307, SEMI F21-1102 .
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    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)
    BS EN ISO 14644-10:2013 Cleanrooms and associated controlled environments Part 10: Classification of surface cleanliness by chemical 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)
    BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
    BS EN ISO 14644-13:2017 Cleanrooms and associated controlled environments Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
    I.S. EN ISO 14644-10:2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CLEANLINESS BY CHEMICAL CONCENTRATION (ISO 14644-10:2013)
    BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments Vocabulary
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    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 10121-2:2013-08 TEST METHODS FOR ASSESSING THE PERFORMANCE OF GAS-PHASE AIR CLEANING MEDIA AND DEVICES FOR GENERAL VENTILATION - PART 2: GAS-PHASE AIR CLEANING DEVICES (GPACD) (ISO 10121-2:2013)
    ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
    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)
    I.S. EN ISO 10121-2:2013 TEST METHODS FOR ASSESSING THE PERFORMANCE OF GAS-PHASE AIR CLEANING MEDIA AND DEVICES FOR GENERAL VENTILATION - PART 2: GAS-PHASE AIR CLEANING DEVICES (GPACD) (ISO 10121-2:2013)
    DIN EN ISO 14644-10:2013-06 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013)
    BS EN ISO 14644-15:2017 Cleanrooms and associated controlled environments Assessment of suitability for use of equipment and materials by airborne chemical concentration
    EN ISO 14644-13:2017 Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
    ISO 15388:2012 Space systems — Contamination and cleanliness control
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    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 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
    16/30326493 DC : 0 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    I.S. EN ISO 14644-15:2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 15: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT AND MATERIALS BY AIRBORNE CHEMICAL CONCENTRATION (ISO 14644-15:2017)
    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
    16/30280732 DC : 0 BS EN ISO 14644-13 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS
    16/30295652 DC : 0 BS EN ISO 14644-15 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 15: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT AND MATERIALS BY AIRBORNE CHEMICAL AND SURFACE CHEMICAL CONCENTRATION
    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
    PD ISO/TR 20811:2017 Optics and photonics. Lasers and laser-related equipment. Laser-induced molecular contamination testing
    DIN EN ISO 14644-13:2016-03 (Draft) CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS (ISO 14644-13:2017)
    UNI EN ISO 10121-2 : 2013 TEST METHODS FOR ASSESSING THE PERFORMANCE OF GAS-PHASE AIR CLEANING MEDIA AND DEVICES FOR GENERAL VENTILATION - PART 2: GASPHASE AIR CLEANING DEVICES (GPACD)
    DIN EN ISO 14644-13 E : 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS (ISO 14644-13:2017)
    05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    BS EN ISO 10121-2:2013 Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation Gas-phase air cleaning devices (GPACD)
    DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    BS ISO 15388:2012 Space systems. Contamination and cleanliness control
    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)
    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
    UNI EN ISO 14644-10 : 2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CLEANLINESS BY CHEMICAL CONCENTRATION
    ISO 14644-13:2017 Cleanrooms and associated controlled environments — Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
    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
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    I.S. EN ISO 14644-13:2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS (ISO 14644-13:2017)
    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)
    UNE-EN ISO 10121-2:2014 Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation - Part 2: Gas-phase air cleaning devices (GPACD) (ISO 10121-2:2013)
    ISO 10121-2:2013 Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation — Part 2: Gas-phase air cleaning devices (GPACD)
    EN ISO 14644-10:2013 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013)
    EN ISO 24998:2008 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008)
    EN ISO 10121-2:2013 Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation - Part 2: Gas-phase air cleaning devices (GPACD) (ISO 10121-2:2013)
    EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    EN ISO 14644-15:2017 Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
    UNE-EN ISO 14644-10:2014 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013)
    11/30196563 DC : 0 BS EN ISO 14644-10 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CHEMICAL CLEANLINESS BY CHEMICAL CONCENTRATION
    ISO 14644-15:2017 Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    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
    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
    ISO/TR 20811:2017 Optics and photonics Lasers and laser-related equipment Laser-induced molecular contamination testing
    16/30341759 DC : 0 BS EN 16602-70-54 - SPACE PRODUCT ASSURANCE - ULTRACLEANING OF FLIGHT HARDWARE
    UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES

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

    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    IEST G CC035.1 : 2009 DESIGN CONSIDERATIONS FOR AIRBORNE MOLECULAR CONTAMINATION FILTRATION SYSTEMS IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
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