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  • VDI 2083 Blatt 5.1:2007-09

    Current The latest, up-to-date edition.

    Cleanroom technology - Cleanroom operation

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-09-2007

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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

    Preliminary Note
    Introduction
    1. Scope
    2. Normative references
    3. Terms and definitions
    4. Specification of operational systems
    5. Cleanroom clothing
    6. Personnel
    7. Stationary systems
    8. Mobile systems and materials
    9. Cleaning in cleanrooms
    Annex A - Definition of process requirements
              (Example)
    Annex B - Steps for selecting cleanroom clothing
    Annex C - Recommendations for specifying
              cleanroom clothing for a desired
              particulate air cleanliness class
              (excluding microbiologically
              monitored environments)
    Annex D - Recommendations for specifying
              cleanroom clothing for a desired
              air cleanliness class/hygiene
              (microbiologically monitored
              environments)
    Annex E - Example of airlock process
    Annex F - Requirements regarding the
              disinfection of sterile rooms and
              aseptic environments
    Annex G - Personnel qualification scheme
    Annex H - Consumables
    Annex I - Thermal comfort in cleanrooms -
              Recommended parameters for comfort
    Bibliography

    Abstract - (Show below) - (Hide below)

    The guideline describes requirements for the operation of clean room systems that are specified as part of quality assurance in order to ensure the respective cleanliness requirements for the process environment.

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

    Development Note Supersedes VDI 2083-2:1996, VDI 2083-4, VDI 2083-5. (12/2007)
    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

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

    DIN 1946-4:2016-06 (Draft) VENTILATION AND AIR CONDITIONING - PART 4: VENTILATION IN BUILDINGS AND ROOMS OF HEALTH CARE
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    VDI 2083 Blatt 13.3:2010-10 Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications
    VDI 6305:2016-12 (Draft) Technical good manufacturing practice - Application guideline for projects in the GMP environment
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
    VDI 6022 Blatt 7.1:2013-10 Ventilation and indoor-air quality - Branch-specific guides - Waste treatment plants
    DIN 1946-4:2008-12 VENTILATION AND AIR CONDITIONING - PART 4: VAC SYSTEMS IN BUILDINGS AND ROOMS USED IN THE HEALTH CARE SECTOR
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    VDI 2083 Blatt 4.2:2011-04 Cleanroom technology - Energy efficiency
    VDI/VDE 2627 Blatt 1:2015-12 Measuring rooms - Classification and characteristics - Planning and execution
    VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms

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

    DIN EN 61340-2-1 : 2016 ELECTROSTATICS - PART 2-1: MEASUREMENT METHODS - ABILITY OF MATERIALS AND PRODUCTS TO DISSIPATE STATIC ELECTRIC CHARGE (IEC 61340-2-1:2015)
    EN ISO 12947-3:1998/AC:2006 Textiles - Determination of the abrasion resistance of fabrics by the Martindale method - Part 3: Determination of mass loss (ISO 12947-3:1998/Cor.1:2002)
    EN 61340-4-5:2004 Electrostatics - Part 4-5: Standard test methods for specific applications - Methods for characterizing the electrostatic protection of footwear and flooring in combination with a person
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    VDI 2083 Blatt 11:2008-01 Cleanroom technology - Quality assurance
    EN 61340-4-3:2001 Electrostatics - Part 4-3: Standard test methods for specific applications - Footwear
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    EN 61340-5-1:2016/AC:2017-05 ELECTROSTATICS - PART 5-1: PROTECTION OF ELECTRONIC DEVICES FROM ELECTROSTATIC PHENOMENA - GENERAL REQUIREMENTS (IEC 61340-5-1:2016/COR1:2017)
    DIN EN ISO 9073-9:2008-06 TEXTILES - TEST METHODS FOR NONWOVENS - PART 9: DETERMINATION OF DRAPABILITY INCLUDING DRAPE COEFFICIENT
    ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
    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
    DIN EN ISO 12947-3:2007-04 Textiles - Determination of abrasion resistance of fabrics by the Martindale method - Part 3: Determination of mass loss (ISO 12947-3:1998 + Cor. 1:2002) (includes Corrigendum AC:2006)
    DIN EN 14683:2014-07 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    IEC 61340-5-1:2016 Electrostatics - Part 5-1: Protection of electronic devices from electrostatic phenomena - General requirements
    EN ISO 9237 : 1995 TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
    IEC 61340-2-3:2016 Electrostatics - Part 2-3: Methods of test for determining the resistance and resistivity of solid materials used to avoid electrostatic charge accumulation
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    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 61340-5-2 : 2002 ELECTROSTATICS - PART 5-2: PROTECTION OF ELECTRONIC DEVICES FROM ELECTROSTATIC PHENOMENA; USER GUIDE
    VDI 2083 Blatt 12:2000-01 Cleanroom technology - Safety and environmental aspects
    VDI 3926 Blatt 1:2004-10 Testing of cleanable filter media - Standard test for the evaluation of cleanable filter media
    DIN 31051:2012-09 FUNDAMENTALS OF MAINTENANCE
    EN ISO 12947-2:2016 Textiles - Determination of the abrasion resistance of fabrics by the Martindale method - Part 2: Determination of specimen breakdown (ISO 12947-2:2016)
    DIN EN 61340-4-3 : 2002 ELECTROSTATICS - PART 4-3: STANDARD TEST METHODS FOR SPECIFIC APPLICATIONS; FOOTWEAR
    EN 61340-2-1:2015 Electrostatics - Part 2-1: Measurement methods - Ability of materials and products to dissipate static electric charge
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    DIN EN ISO 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    DIN EN 61340-4-5 : 2005 ELECTROSTATICS - PART 4-5: STANDARD TEST METHODS FOR SPECIFIC APPLICATIONS - METHODS FOR CHARACTERIZING THE ELECTROSTATIC PROTECTION OF FOOTWEAR AND FLOORING IN COMBINATION WITH A PERSON
    IEC 61340-4-3:2001 Electrostatics - Part 4-3: Standard test methods for specific applications - Footwear
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    DIN EN 61340-5-1 : 2017 ELECTROSTATICS - PART 5-1: PROTECTION OF ELECTRONIC DEVICES FROM ELECTROSTATIC PHENOMENA - GENERAL REQUIREMENTS (IEC 61340-5-1:2016)
    IEC 61340-4-1:2003+AMD1:2015 CSV Electrostatics - Part 4-1: Standard test methods for specific applications - Electrical resistance of floor coverings and installed floors
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    DIN EN ISO 12947-1:2007-04 Textiles - Determination of the abrasion resistance of fabrics by the Martindale method - Part 1: Martindale abrasion testing apparatus (ISO 12947-1:1998 + Cor. 1:2002) (includes Corrigendum AC:2006)
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    VDI 2083 Blatt 5:1996-02 Cleanroom technology - Thermal comfort
    EN 14683:2014 Medical face masks - Requirements and test methods
    EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    DIN EN 61340-2-3 : 2017 ELECTROSTATICS - PART 2-3: METHODS OF TEST FOR DETERMINING THE RESISTANCE AND RESISTIVITY OF SOLID MATERIALS USED TO AVOID ELECTROSTATIC CHARGE ACCUMULATION (IEC 61340-2-3:2016)
    ISO 12947-4:1998 Textiles — Determination of the abrasion resistance of fabrics by the Martindale method — Part 4: Assessment of appearance change
    IEC 61340-2-1:2015 Electrostatics - Part 2-1: Measurement methods - Ability of materials and products to dissipate static electric charge
    EN ISO 12947-1:1998/AC:2006 TEXTILES - DETERMINATION OF THE ABRASION RESISTANCE OF FABRICS BY THE MARTINDALE METHOD - PART 1: MARTINDALE ABRASION TESTING APPARATUS
    EN 61340-4-1:2004/A1:2015 ELECTROSTATICS - PART 4-1: STANDARD TEST METHODS FOR SPECIFIC APPLICATIONS - ELECTRICAL RESISTANCE OF FLOOR COVERINGS AND INSTALLED FLOORS (IEC 61340-4-1:2003/A1:2015)
    EN 31092:1993/A1:2012 TEXTILES - DETERMINATION OF PHYSIOLOGICAL PROPERTIES - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED - HOTPLATE TEST) (ISO 11092:1993/AMD 1:2012)
    IEC 61340-4-5:2004 Electrostatics - Part 4-5: Standard test methods for specific applications - Methods for characterizing the electrostatic protection of footwear and flooring in combination with a person
    DIN EN 61340-3-1 : 2008 ELECTROSTATICS - PART 3-1: METHODS FOR SIMULATION OF ELECTROSTATIC EFFECTS - HUMAN BODY MODEL (HBM) - ELECTROSTATIC DISCHARGE TEST WAVEFORMS
    DIN EN ISO 12947-4:2007-04 Textiles - Determination of abrasion resistance of fabrics by the Martindale method - Part 4: Assessment of appearance change (ISO 12947-4:1998 + Cor. 1:2002) (includes Corrigendum AC:2006)
    DIN EN 31092:2013-01 TEXTILES - PHYSIOLOGICAL EFFECTS - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED-HOTPLATE TEST) (ISO 11092:1993 + AMD.1:2012)
    ISO 12947-2:2016 Textiles — Determination of the abrasion resistance of fabrics by the Martindale method — Part 2: Determination of specimen breakdown
    EN ISO 12947-4:1998/AC:2006 TEXTILES - DETERMINATION OF THE ABRASION RESISTANCE OF FABRICS BY THE MARTINDALE METHOD - PART 4: ASSESSMENT OF APPEARANCE CHANGE
    EN 61340-2-3:2016 Electrostatics - Part 2-3: Methods of test for determining the resistance and resistivity of solid materials used to avoid electrostatic charge accumulation
    DIN EN 61340-3-2 : 2007 ELECTROSTATICS - PART 3-2: METHODS FOR SIMULATION OF ELECTROSTATIC EFFECTS - MACHINE MODEL (MM) ELECTROSTATIC DISCHARGE TEST WAVEFORMS
    DIN EN 61340-4-1 : 2016 ELECTROSTATICS - PART 4-1: STANDARD TEST METHODS FOR SPECIFIC APPLICATIONS - ELECTRICAL RESISTANCE OF FLOOR COVERINGS AND INSTALLED FLOORS (IEC 61340-4-1:2003 + A1:2015)
    ISO 12947-3:1998 Textiles — Determination of the abrasion resistance of fabrics by the Martindale method — Part 3: Determination of mass loss
    DIN EN ISO 12947-2:2015-09 (Draft) TEXTILES - DETERMINATION OF THE ABRASION RESISTANCE OF FABRICS BY THE MARTINDALE METHOD - PART 2: DETERMINATION OF SPECIMEN BREAKDOWN (ISO 12947-2:2016)
    EN 1149-3:2004 Protective clothing - Electrostatic properties - Part 3: Test methods for measurement of charge decay
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