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ISO
ISO 14644-4:2001

ISO 14644-4:2001

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

12-04-2001

Publisher

International Organization for Standardization

Withdrawn date

09-04-2025

Superseded by

ISO 14644-4:2022

€63.00
Excluding VAT

Committee
ISO/TC 209
DocumentType
Standard
Pages
51
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
11/30248115 DC : 0 BS EN ISO 14644-8 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION
BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL 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)
GOST ISO 14698-1 : 2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
ISO 18362:2016 Manufacture of cell-based health care products — Control of microbial risks during processing
ASTM E 2217 : 2012 : REDLINE Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
I.S. EN ISO 14644-3:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments Vocabulary
ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
DIN EN ISO 14644-8:2013-06 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
DIN EN ISO 14698-1:2004-04 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
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)
02/123800 DC : DRAFT OCT 2002 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: METROLOGY AND TEST METHODS
DIN EN ISO 13408-1:2015-12 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
AAMI ISO 11737-2 :2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
ASTM E 2352 : 2019 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
ASTM E 2352 : 2004 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
ISO 14644-6:2007 Cleanrooms and associated controlled environments — Part 6: Vocabulary
BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
I.S. EN ISO 14644-8:2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION (ACC) (ISO 14644-8:2013)
I.S. EN ISO 14698-1:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
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 15:2007-04 Cleanroom technology - Personnel at the clean work place
VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
16/30326493 DC : 0 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
BS ISO 15388:2012 Space systems. Contamination and cleanliness control
BS PD ISO/TR 14969 : 2004 AMD 15958 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
01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
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/TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ASTM E 2352 : 2004 : R2010 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
ISO 15388:2012 Space systems — Contamination and cleanliness control
DIN EN ISO 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
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)
ISO 14644-8:2013 Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness by chemical concentration (ACC)
BS EN ISO 14644-8:2013 Cleanrooms and associated controlled environments Classification of air cleanliness by chemical concentration (ACC)
ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
I.S. EN ISO 11737-2:2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
EN ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
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)
05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
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 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
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
01/122934 DC : DRAFT AUG 2001 BS EN ISO 14644-5 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS
07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
00/705381 DC : DRAFT FEB 2000 ISO/CD 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 24998:2008 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
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
BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments Operations
EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments Test methods
ISO 14698-1:2003 Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
I.S. 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)
EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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 24998:2008 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008)
EN ISO 14644-6:2007 Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007)
EN ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005)
EN ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
04/30112669 DC : DRAFT APR 2004 BS EN ISO 14644-8 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - CLASSIFICATION OF AIRBORNE MOLECULAR CONTAMINATION
DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
PREN ISO 14644-8 : DRAFT 2011 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 8: CLASSIFICATION OF AIR CLEANLINESS BY CHEMICAL CONCENTRATION (ISO/DIS 14644-8:2011)
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)
ONORM EN ISO 14644-3 : 2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
ISO 14644-3:2005 Cleanrooms and associated controlled environments — Part 3: Test methods
DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004
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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE-EN ISO 14644-2:2016 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)
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 14644-8:2014 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
I.S. EN ISO 14644-7:2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE DEVICES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS AND MINI-ENVIRONMENTS)
UNE 171340:2012 Validation and evaluation of controlled environment rooms in hospitals
I.S. EN ISO 14644-5:2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS
ONORM EN ISO 13408-1 : 2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)

ISO 9004-1:1994 Quality management and quality system elements — Part 1: Guidelines
VDI 2083 Blatt 2:2015-04 Cleanroom technology - Stipulations regarding the checking and monitoring of continued compliance with specifications
ISO 14698-2:2003 Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
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
EN 1822-5:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 5: Determining the efficiency of filter elements
ISO 1940-1:2003 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances
EN 779:2012 Particulate air filters for general ventilation - Determination of the filtration performance
EN 1822-2:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics
VDI 2083 Blatt 4:1996-02 Cleanroom technology - Surface cleanliness
ISO 14698-1:2003 Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
ISO 3746:2010 Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 14004:2016 Environmental management systems — General guidelines on implementation
ISO 14644-3:2005 Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO 10816-1:1995 Mechanical vibration — Evaluation of machine vibration by measurements on non-rotating parts — Part 1: General guidelines
ISO 14001:2015 Environmental management systems — Requirements with guidance for use
ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015 Quality management systems — Requirements
ISO 7730:2005 Ergonomics of the thermal environment — Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria
EN 1822-3:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 3: Testing flat sheet filter media
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
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)
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
EN 1822-4:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method)

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Hardcopy - English
PDF - English
Hardcopy - French
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Hardcopy - English
PDF - English
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