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  • VDI 2083 Blatt 18:2012-01

    Current The latest, up-to-date edition.

    Cleanroom technology - Biocontamination control

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-01-2012

    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. Abbreviations.
    5. Hygienic design
    6. Selection of materials
    7. Cleaning/disinfection
    8. Biomonitoring of cleanrooms
    Annex Test methods
    Bibliography

    Abstract - (Show below) - (Hide below)

    Microbial contaminants on surfaces and in the air (including cleanroom air), as addressed by this guideline, include all microorganisms capable of proliferation (bacteria and their spores, fungi and their spores) and capable of having harmful effects on products by their settling and proliferating on them.

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

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

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

    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    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 20566:2013 Paints and varnishes - Determination of the scratch resistance of a coating system using a laboratory-scale car-wash (ISO 20566:2013)
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    DIN EN ISO 20566:2013-06 Paints and varnishes - Determination of the scratch resistance of a coating system using a laboratory-scale car-wash (ISO 20566:2013)
    DIN EN ISO 4628-1:2016-07 PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 1: GENERAL INTRODUCTION AND DESIGNATION SYSTEM (ISO 4628-1:2016)
    EN ISO 4628-2:2016 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 2: Assessment of degree of blistering (ISO 4628-2:2016)
    VDI 6022 Blatt 3:2011-07 Ventilation and indoor-air quality - Assessment of indoor-air quality
    DIN 10524:2012-04 FOOD HYGIENE - WORK WEAR IN FOOD BUSINESS
    DIN EN 828:2013-04 Adhesives - Wettability - Determination by measurement of contact angle and surface free energy of solid surface
    DIN 10113-2:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 2: Semiquantitative swab method
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    EN ISO 11998 : 2006 Paints and varnishes - Determination of wet-scrub resistance and cleanability of coatings (ISO 11998:2006)
    EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
    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)
    DIN EN ISO 22612:2005-05 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005); German version EN ISO 22612:2005
    VDI 4252 Blatt 2:2004-06 Measurement of airborne microorganisms and viruses in ambient air - Active sampling of bioaerosols - Separation of airborne mould on gelatine/polycarbonate filters
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    DIN 10113-1:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 1: Quantitative swab method
    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)
    EN ISO 4628-1:2016 PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 1: GENERAL INTRODUCTION AND DESIGNATION SYSTEM (ISO 4628-1:2016)
    DIN EN 13523-16:2005-02 Coil coated metals - Test methods - Part 16: Resistance to abrasion
    VDE 0300-4-5 : 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
    DIN EN ISO 846:1997-10 PLASTICS - EVALUATION OF THE ACTION OF MICROORGANISMS
    DVGW W 270 : 2007 MICROBIAL ENHANCEMENT ON MATERIALS TO COME INTO CONTACT WITH DRINKING WATER - TESTING AND ASSESSMENT
    ISO 4516:2002 Metallic and other inorganic coatings — Vickers and Knoop microhardness tests
    DIN EN 1650:2013-08 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS AND ANTISEPTICS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    DIN EN 1040:2006-03 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1); German version EN 1040:2005
    EN 13697:2015 Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2, step 2)
    IEC 61340-5-1:2016 Electrostatics - Part 5-1: Protection of electronic devices from electrostatic phenomena - General requirements
    PREN ISO 14644-9 : DRAFT 2008 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 9: CLASSIFICATION OF SURFACE PARTICLE CLEANLINESS
    DIN EN 1276:2010-01 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS AND ANTISEPTICS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
    DIN EN 1632-4:1995-02 (Draft) CLEANROOM TECHNOLOGY - BIOCONTAMINATION CONTROL - PART 4: METHODS OF ANALYZING AND MEASURING AEROBIOCONTAMINATION IN ZONES AT RISK
    EN ISO 14577-1:2015 Metallic materials - Instrumented indentation test for hardness and materials parameters - Part 1: Test method (ISO 14577-1:2015)
    DIN EN ISO 4628-2:2016-07 PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 2: ASSESSMENT OF DEGREE OF BLISTERING (ISO 4628-2:2016)
    DIN EN ISO 22610:2015-12 (Draft) SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION
    DIN EN ISO 2812-1:2007-05 PAINTS AND VARNISHES - DETERMINATION OF RESISTANCE TO LIQUIDS - PART 1: IMMERSION IN LIQUIDS OTHER THAN WATER (ISO 2812-1:2017)
    ISO 846:1997 Plastics Evaluation of the action of microorganisms
    VDE 0300-5-1 : 2017 ELECTROSTATICS - PART 5-1: PROTECTION OF ELECTRONIC DEVICES FROM ELECTROSTATIC PHENOMENA - GENERAL REQUIREMENTS (IEC 61340-5-1:2016)
    DIN 53233:2016-03 PAINTS AND VARNISHES - DETERMINATION OF ABRASION BEHAVIOUR
    DIN EN ISO 14644-4:2003-06 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)
    PREN 828 : DRAFT 2010 ADHESIVES - WETTABILITY - DETERMINATION BY MEASUREMENT OF CONTACT ANGLE AND SURFACE FREE ENERGY OF SOLID SURFACE
    DIN EN ISO 4628-4:2016-07 PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 4: ASSESSMENT OF DEGREE OF CRACKING (ISO 4628-4:2016)
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
    VDI 4253 Blatt 3:2008-08 Measurement of airborne microorganisms and viruses in ambient air - Culture based method for the quantitative determination of bacteria in air - Method after separation in liquids
    EN ISO 4628-4:2016 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 4: Assessment of degree of cracking (ISO 4628-4:2016)
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    EN ISO 7784-1:2016 Paints and varnishes - Determination of resistance to abrasion - Part 1: Method with abrasive-paper covered wheels and rotating test specimen (ISO 7784-1:2016)
    ISO 20566:2013 Paints and varnishes Determination of the scratch resistance of a coating system using a laboratory-scale car-wash
    ISO 4628-3:2016 Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 3: Assessment of degree of rusting
    PREN ISO 14644-1 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION
    EN ISO 14159:2008 Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002)
    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
    EN 13523-16:2004 Coil coated metals - Test methods - Part 16: Resistance to abrasion
    EN ISO 4628-3:2016 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 3: Assessment of degree of rusting (ISO 4628-3:2016)
    ASTM D 1044 : 2013 : REDLINE Standard Test Method for Resistance of Transparent Plastics to Surface Abrasion
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    EN 13098:2000 Workplace atmosphere - Guidelines for measurement of airborne micro-organisms and endotoxin
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    DIN EN 13795:2013-10 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
    EN 1672-2:2005+A1:2009 Food processing machinery - Basic concepts - Part 2: Hygiene requirements
    ISO 2812-4:2017 Paints and varnishes — Determination of resistance to liquids — Part 4: Spotting methods
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    DIN EN ISO 11998:2006-10 Paints and varnishes - Determination of wet-scrub resistance and cleanability of coatings (ISO 11998:2006)
    ISO 4628-5:2016 Paints and varnishes — Evaluation of degradation of coatings — Designation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 5: Assessment of degree of flaking
    EN 14065:2016 Textiles - Laundry processed textiles - Biocontamination control system
    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 4628-1:2016 Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 1: General introduction and designation system
    DIN 8592:2003-09 MANUFACTURING PROCESSES CLEANING - CLASSIFICATION, SUBDIVISION, TERMS AND DEFINITIONS
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    DIN EN 14065:2016-08 TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM
    DIN EN 1081:1998-04 RESILIENT FLOOR COVERINGS - DETERMINATION OF THE ELECTRICAL RESISTANCE
    EN 15457:2014 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against fungi
    ISO 22196:2011 Measurement of antibacterial activity on plastics and other non-porous surfaces
    ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration
    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 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    ISO 14577-1:2015 Metallic materials Instrumented indentation test for hardness and materials parameters Part 1: Test method
    VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
    ISO 11998:2006 Paints and varnishes — Determination of wet-scrub resistance and cleanability of coatings
    EN ISO 846 : 1997 PLASTICS - EVALUATION OF THE ACTION OF MICROORGANISMS
    DIN EN 1672-2:2009-07 Food processing machinery - Basic concepts - Part 2: Hygiene requirements (includes Amendment A1:2009)
    ISO 2812-1:2017 Paints and varnishes — Determination of resistance to liquids — Part 1: Immersion in liquids other than water
    EN 10049:2013 Measurement of roughness average Ra and peak count RPc on metallic flat products
    DIN EN ISO 14577-1:2015-11 Metallic materials - Instrumented indentation test for hardness and materials parameters - Part 1: Test method (ISO 14577-1:2015); German version EN ISO 14577-1:2015
    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 13697:2015-06 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST FOR THE EVALUATION OF BACTERICIDAL AND/OR FUNGICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS WITHOUT MECHANICAL ACTION (PHASE 2, STEP 2)
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    VDE 0300-4-1 : 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)
    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)
    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    DIN EN ISO 4628-3:2016-07 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 3: Assessment of degree of rusting (ISO 4628-3:2016); German version EN ISO 4628-3:2016
    DIN EN ISO 14159:2008-07 SAFETY OF MACHINERY - HYGIENE REQUIREMENTS FOR THE DESIGN OF MACHINERY
    DIN EN 10049:2014-03 Measurement of roughness average Ra and peak count RPc on metallic flat products
    DIN EN ISO 2812-4:2007-05 PAINTS AND VARNISHES - DETERMINATION OF RESISTANCE TO LIQUIDS - PART 4: SPOTTING METHODS (ISO 2812-4:2017)
    EN ISO 4628-5:2016 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 5: Assessment of degree of flaking (ISO 4628-5:2016)
    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 14583:2004 Workplace atmospheres - Volumetric bioaerosol sampling devices - Requirements and test methods
    VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
    ISO 7784-1:2016 Paints and varnishes — Determination of resistance to abrasion — Part 1: Method with abrasive-paper covered wheels and rotating test specimen
    EN 1081:1998 Resilient floor coverings - Determination of the electrical resistance
    VDI 4257 Blatt 2:2011-09 Bioaerosols and biological agents - Emission measurement - Sampling of bioaerosols and separation in liquids
    EN 1650:2008+A1:2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS AND ANTISEPTICS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
    DIN EN 15457:2014-11 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against fungi
    VDI 2083 Blatt 5.2:2008-10 Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing
    DIN EN ISO 4628-5:2016-07 Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 5: Assessment of degree of flaking (ISO 4628-5:2016)
    DIN 10113-3:1997-07 Determination of surface colony count on fitment and utensils in foodareas - Part 3: Semiquantitative method with culture media laminated taking up equipment (squeeze method)
    BS 3900-G6:1989 Methods of test for paints Assessment of resistance to fungal growth
    EN 1276:2009/AC:2010 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS AND ANTISEPTICS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
    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 4628-2:2016 Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 2: Assessment of degree of blistering
    EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
    DIN EN ISO 7784-1:2006-07 PAINTS AND VARNISHES - DETERMINATION OF RESISTANCE TO ABRASION - PART 1: METHOD WITH ABRASIVE-PAPER COVERED WHEELS AND ROTATING TEST SPECIMEN (ISO 7784-1:2016)
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