ISO 14644-8:2013
Withdrawn
View Superseded by
Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness by chemical concentration (ACC)
Hardcopy , PDF
French, English
02-18-2013
04-09-2025
ISO 14644-8:2013 establishes the classification of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.
ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2013 is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of ISO 14644-8:2013 to describe the nature of air chemical contaminants.
ISO 14644-8:2013 does not give a classification of surface chemical contamination.
| Committee |
ISO/TC 209
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| DevelopmentNote |
Supersedes ISO/DIS 14644-8. (02/2013)
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| DocumentType |
Standard
|
| Pages |
22
|
| ProductNote |
THIS STANDARD ALSO REFERS ISO 14698 , IEST-G-CC035, ASTM D5127-99, SEMI E108-0307, IEST-RP-CC031.2, JIS B9917-8:2010, SEMI E45-1101,SEMI E460307, SEMI F21-1102 .
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 14644-8:2013-06 | Identical |
| GOST R ISO 14644-8 : 2014 | Identical |
| NBN EN ISO 14644-8 : 2013 | Identical |
| NF EN ISO 14644-8 : 2013 | Identical |
| NEN EN ISO 14644-8 : 2013 | Identical |
| NS EN ISO 14644-8 : 2013 | Identical |
| I.S. EN ISO 14644-8:2013 | Identical |
| PN EN ISO 14644-8 : 2013 | Identical |
| SS-EN ISO 14644-8 : 2013 | Identical |
| BS EN ISO 14644-8:2013 | Identical |
| EN ISO 14644-8:2013 | Identical |
| UNE-EN ISO 14644-8:2014 | Identical |
| EN ISO 15378:2017 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017) |
| BS EN ISO 14644-10:2013 | Cleanrooms and associated controlled environments Part 10: Classification of surface cleanliness by chemical concentration |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| BS EN ISO 24998:2008 | Plastics laboratory ware. Single-use Petri dishes for microbiological procedures |
| BS EN ISO 14644-13:2017 | Cleanrooms and associated controlled environments Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications |
| I.S. EN ISO 14644-10:2013 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CLEANLINESS BY CHEMICAL CONCENTRATION (ISO 14644-10:2013) |
| BS EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments Vocabulary |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| IEC/IEEE 62659:2015 | Nanomanufacturing - Large scale manufacturing for nanoelectronics |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| DIN EN ISO 10121-2:2013-08 | TEST METHODS FOR ASSESSING THE PERFORMANCE OF GAS-PHASE AIR CLEANING MEDIA AND DEVICES FOR GENERAL VENTILATION - PART 2: GAS-PHASE AIR CLEANING DEVICES (GPACD) (ISO 10121-2:2013) |
| ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| I.S. EN ISO 10121-2:2013 | TEST METHODS FOR ASSESSING THE PERFORMANCE OF GAS-PHASE AIR CLEANING MEDIA AND DEVICES FOR GENERAL VENTILATION - PART 2: GAS-PHASE AIR CLEANING DEVICES (GPACD) (ISO 10121-2:2013) |
| DIN EN ISO 14644-10:2013-06 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013) |
| BS EN ISO 14644-15:2017 | Cleanrooms and associated controlled environments Assessment of suitability for use of equipment and materials by airborne chemical concentration |
| EN ISO 14644-13:2017 | Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017) |
| ISO 15388:2012 | Space systems — Contamination and cleanliness control |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments — Part 6: Vocabulary |
| I.S. EN ISO 14644-6:2007 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| VDI 2083 Blatt 17:2013-06 | Cleanroom technology - Compatibility of materials with the required cleanliness |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| VDI 2083 Blatt 8.1:2014-10 | Cleanroom technology - Air cleanliness chemical concentration (ACC) |
| VDI 2083 Blatt 1:2013-01 | Cleanroom technology - Particulate air cleanliness classes |
| 16/30326493 DC : 0 | BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS |
| I.S. EN ISO 14644-15:2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 15: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT AND MATERIALS BY AIRBORNE CHEMICAL CONCENTRATION (ISO 14644-15:2017) |
| 14/30280736 DC : 0 | BS EN ISO 14644-14 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 14 ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT BY AIRBORNE PARTICLE CONCENTRATION |
| 16/30280732 DC : 0 | BS EN ISO 14644-13 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS |
| 16/30295652 DC : 0 | BS EN ISO 14644-15 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 15: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT AND MATERIALS BY AIRBORNE CHEMICAL AND SURFACE CHEMICAL CONCENTRATION |
| BS PD ISO/TR 14969 : 2004 AMD 15958 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI ISO TIR 14969 : 2004 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| PD ISO/TR 20811:2017 | Optics and photonics. Lasers and laser-related equipment. Laser-induced molecular contamination testing |
| DIN EN ISO 14644-13:2016-03 (Draft) | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS (ISO 14644-13:2017) |
| 05/30142385 DC : DRAFT NOV 2005 | ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| BS EN ISO 10121-2:2013 | Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation Gas-phase air cleaning devices (GPACD) |
| DIN EN ISO 24998:2009-03 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| BS ISO 15388:2012 | Space systems. Contamination and cleanliness control |
| BS EN ISO 15378:2017 | Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| 14/30289934 DC : 0 | BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES |
| 10/30234886 DC : 0 | BS ISO 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL |
| ISO 14644-13:2017 | Cleanrooms and associated controlled environments — Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications |
| 07/30163423 DC : 0 | BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| I.S. EN ISO 14644-13:2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 13: CLEANING OF SURFACES TO ACHIEVE DEFINED LEVELS OF CLEANLINESS IN TERMS OF PARTICLE AND CHEMICAL CLASSIFICATIONS (ISO 14644-13:2017) |
| ISO/TR 14969:2004 | Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 |
| I.S. EN ISO 24998:2008 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| I.S. EN ISO 15378:2017 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
| ISO 10121-2:2013 | Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation — Part 2: Gas-phase air cleaning devices (GPACD) |
| EN ISO 14644-10:2013 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013) |
| EN ISO 24998:2008 | Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008) |
| EN ISO 10121-2:2013 | Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation - Part 2: Gas-phase air cleaning devices (GPACD) (ISO 10121-2:2013) |
| EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
| EN ISO 14644-15:2017 | Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017) |
| 11/30196563 DC : 0 | BS EN ISO 14644-10 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CHEMICAL CLEANLINESS BY CHEMICAL CONCENTRATION |
| ISO 14644-15:2017 | Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| BS ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
| ISO 24998:2008 | Plastics laboratory ware — Single-use Petri dishes for microbiological procedures |
| ISO/TR 20811:2017 | Optics and photonics — Lasers and laser-related equipment — Laser-induced molecular contamination testing |
| 16/30341759 DC : 0 | BS EN 16602-70-54 - SPACE PRODUCT ASSURANCE - ULTRACLEANING OF FLIGHT HARDWARE |
| I.S. EN ISO 14644-3:2019&LC:2020 | Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06) |
| UNE-EN ISO 14644-10:2014 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013) |
| UNE-EN ISO 15378:2016 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) |
| UNE-EN ISO 10121-2:2014 | Test methods for assessing the performance of gas-phase air cleaning media and devices for general ventilation - Part 2: Gas-phase air cleaning devices (GPACD) (ISO 10121-2:2013) |
| UNE 171340:2012 | Validation and evaluation of controlled environment rooms in hospitals |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments — Part 6: Vocabulary |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |