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  • VDI 2083 Blatt 8.1:2014-10

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    Cleanroom technology - Air cleanliness chemical concentration (ACC)

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-10-2014

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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

    1 Scope
    2 Terms and definitions
    3 Abbreviations
    4 Sources, avoidance or removal
       of chemical contamination
    5 Metrology
    6 Filtration
    7 Sources of chemical contamination
       in pharmaceutics and medical
       engineering
    8 Food
    9 Micro- and nanotechnologies and
       other technical systems
    10 Cleaning/disinfection of the
       production environment
    Annex A - Chemical effects of cleaning
              on the production environment
    Annex B - Metrology
    Annex C - Filtration
    Annex D - Examples of effects of chemical
              contamination in the micro- and
              nanotechnologies and in other
              technical systems
    Annex E - Examples of typical concentrations
              of chemical contaminations in
              outdoor air and in cleanrooms
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard deals with the control and determination of chemical contamination in cleanrooms in order to protect process, product and personnel.

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

    Development Note Supersedes VDI 2083-14. (07/2009)
    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

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

    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
    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

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

    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    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)
    VDI 2083 Blatt 11:2008-01 Cleanroom technology - Quality assurance
    ISO 14644-8:2013 Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
    ISO 22000:2005 Food safety management systems Requirements for any organization in the food chain
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    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
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    VDI 2083 Blatt 10:1998-02 Cleanroom technology - High-Purity/Ultra-High-Purity (HP-/UHP-)media supply systems
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14644-5:2004 Cleanrooms and associated controlled environments Part 5: Operations
    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
    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)
    VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
    VDI 2083 Blatt 12:2000-01 Cleanroom technology - Safety and environmental aspects
    VDI 2083 Blatt 13.1:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
    VDI 2083 Blatt 13.3:2010-10 Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications
    DIN EN ISO 14644-4:2003-06 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)
    2000/70/EC : 2000 DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 NOVEMBER 2000 AMENDING COUNCIL DIRECTIVE 93/42/EC AS REGARDS MEDICAL DEVICES INCORPORATING STABLE DERIVATES OF HUMAN BLOOD OR HUMAN PLASMA
    2006/42/EC : 2006 AMD 4 2014 DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 17 MAY 2006 ON MACHINERY, AND AMENDING DIRECTIVE 95/16/EC (RECAST) (TEXT WITH EEA RELEVANCE)
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
    EN 779:2012 Particulate air filters for general ventilation - Determination of the filtration performance
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    EN ISO 22000:2005 Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2005)
    DIN EN ISO 14644-6:2007-10 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    DIN EN ISO 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    PREN ISO 14644-1 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION
    DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
    DIN EN ISO 14644-9:2012-12 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)
    EN 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)
    VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
    VDI 3674:2013-04 Waste gas cleaning by adsorption - Process gas and waste gas cleaning
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    VDI 2083 Blatt 7:2015-10 Cleanroom technology - Ultrapure media - Quality, supply, distribution
    ISO 9001:2015 Quality management systems — Requirements
    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    92/42/EEC : 1992 AMD 5 2013 COUNCIL DIRECTIVE 92/42/EEC OF 21 MAY 1992 ON EFFICIENCY REQUIREMENTS FOR NEW HOT-WATER BOILERS FIRED WITH LIQUID OR GASEOUS FUELS
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    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)
    VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    VDI 2083 Blatt 5.2:2008-10 Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing
    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 14644-9:2012 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)
    DIN EN ISO 22000:2005-11 FOOD SAFETY MANAGEMENT SYSTEMS - REQUIREMENTS FOR ANY ORGANIZATION IN THE FOOD CHAIN
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 14644-9:2012 Cleanrooms and associated controlled environments Part 9: Classification of surface cleanliness by particle concentration
    EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
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