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VDI 2083 Blatt 5.1:2007-09

Current
Current

The latest, up-to-date edition.

Cleanroom technology - Cleanroom operation
Available format(s)

Hardcopy , PDF

Language(s)

German - English

Published date

09-01-2007

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

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.

DevelopmentNote
Supersedes VDI 2083-2:1996, VDI 2083-4, VDI 2083-5. (12/2007)
DocumentType
Standard
Pages
95
PublisherName
Verlag des Vereins Deutscher Ingenieure
Status
Current
Supersedes

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

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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