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
01-09-2007
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 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 (ISO 14698-1:2003) |
| 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 (ISO 9237:1995) |
| 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) |
| 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 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) |
| 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 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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