VDI 2083 Blatt 8.1:2014-10
Current
Current
The latest, up-to-date edition.
Cleanroom technology - Air cleanliness chemical concentration (ACC)
Available format(s)
Hardcopy , PDF
Language(s)
German - English
Published date
01-10-2014
Publisher
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1 Scope
2 Terms and definitions
3 Abbreviations
4 Sources, avoidance or removal
of chemical contamination
5 Metrology
6 Filtration
7 Sources of chemical contamination
in pharmaceutics and medical
engineering
8 Food
9 Micro- and nanotechnologies and
other technical systems
10 Cleaning/disinfection of the
production environment
Annex A - Chemical effects of cleaning
on the production environment
Annex B - Metrology
Annex C - Filtration
Annex D - Examples of effects of chemical
contamination in the micro- and
nanotechnologies and in other
technical systems
Annex E - Examples of typical concentrations
of chemical contaminations in
outdoor air and in cleanrooms
Bibliography
This standard deals with the control and determination of chemical contamination in cleanrooms in order to protect process, product and personnel.
| DevelopmentNote |
Supersedes VDI 2083-14. (07/2009)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Current
|
| Supersedes |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| VDI 2083 Blatt 17:2013-06 | Cleanroom technology - Compatibility of materials with the required cleanliness |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 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 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| 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) |
| VDI 2083 Blatt 11:2008-01 | Cleanroom technology - Quality assurance |
| ISO 14644-8:2013 | Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| ISO 22000:2005 | Food safety management systems Requirements for any organization in the food chain |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| DIN EN ISO 14644-3:2006-03 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS |
| 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 |
| VDI 2083 Blatt 3:2005-07 | Cleanroom technology - Metrology and test methods |
| VDI 2083 Blatt 1:2013-01 | Cleanroom technology - Particulate air cleanliness classes |
| VDI 2083 Blatt 10:1998-02 | Cleanroom technology - High-Purity/Ultra-High-Purity (HP-/UHP-)media supply systems |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| PREN ISO 14644-2 : DRAFT 2010 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1 |
| 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) |
| VDI 2083 Blatt 13.2:2009-01 | Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications |
| VDI 2083 Blatt 12:2000-01 | Cleanroom technology - Safety and environmental aspects |
| VDI 2083 Blatt 13.1:2009-01 | Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals |
| VDI 2083 Blatt 13.3:2010-10 | Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications |
| DIN EN ISO 14644-4:2003-06 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001) |
| 2000/70/EC : 2000 | DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 NOVEMBER 2000 AMENDING COUNCIL DIRECTIVE 93/42/EC AS REGARDS MEDICAL DEVICES INCORPORATING STABLE DERIVATES OF HUMAN BLOOD OR HUMAN PLASMA |
| VDI 2083 Blatt 4.1:2006-10 | Cleanroom technology - Planning, construction and start-up of cleanrooms |
| EN 779:2012 | Particulate air filters for general ventilation - Determination of the filtration performance |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| EN ISO 22000:2005 | Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2005) |
| DIN EN ISO 14644-6:2007-10 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| DIN EN ISO 14644-5:2005-03 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| PREN ISO 14644-1 : DRAFT 2010 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| VDI 1000:2017-02 | VDI Standardisation Work - Principles and procedures |
| VDI 2083 Blatt 16.1:2010-08 | Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| EN ISO 14644-8:2013 | Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013) |
| 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 ISO 14644-5:2004 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| VDI 2083 Blatt 5.1:2007-09 | Cleanroom technology - Cleanroom operation |
| VDI 3674:2013-04 | Waste gas cleaning by adsorption - Process gas and waste gas cleaning |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| VDI 2083 Blatt 7:2015-10 | Cleanroom technology - Ultrapure media - Quality, supply, distribution |
| ISO 9001:2015 | Quality management systems — Requirements |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| 92/42/EEC : 1992 AMD 5 2013 | COUNCIL DIRECTIVE 92/42/EEC OF 21 MAY 1992 ON EFFICIENCY REQUIREMENTS FOR NEW HOT-WATER BOILERS FIRED WITH LIQUID OR GASEOUS FUELS |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| EN 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 (ISO 14644-2:2015) |
| VDI 2083 Blatt 9.1:2006-12 | Clean room technology - Compatibility with required cleanliness and surface cleanliness |
| EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
| VDI 2083 Blatt 5.2:2008-10 | Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN ISO 14644-9:2012 | Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012) |
| DIN EN ISO 22000:2005-11 | FOOD SAFETY MANAGEMENT SYSTEMS - REQUIREMENTS FOR ANY ORGANIZATION IN THE FOOD CHAIN |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14644-9:2012 | Cleanrooms and associated controlled environments Part 9: Classification of surface cleanliness by particle concentration |
| EN ISO 14644-3:2005 | Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005) |
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