VDI 2083 Blatt 18:2012-01
Current
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
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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
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.
| DocumentType |
Standard
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| Pages |
32
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| PublisherName |
Verlag des Vereins Deutscher Ingenieure
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| Status |
Current
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| Supersedes |
| 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 |
| 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 |
| 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 (ISO 846:1997) |
| 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) |
| 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 (ISO 14159:2002) |
| 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 |
| 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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