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ISO 14644-8:2013

Withdrawn

Withdrawn

View Superseded by

Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness by chemical concentration (ACC)

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

02-18-2013

Withdrawn date

04-09-2025

Superseded by

ISO 14644-8:2022

US$96.00
Excluding Tax where applicable

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
DevelopmentNote
Supersedes ISO/DIS 14644-8. (02/2013)
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 .
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

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

US$96.00
Excluding Tax where applicable