ISO 14644-4:2001
Withdrawn
Withdrawn
View Superseded by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
04-12-2001
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
| Committee |
ISO/TC 209
|
| DocumentType |
Standard
|
| Pages |
51
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DS EN ISO 14644-4 : 2001 | Identical |
| GOST R ISO 14644-4 : 2002 | Identical |
| NBN EN ISO 14644-4 : 2001 | Identical |
| NF EN ISO 14644-4 : 2001 | Identical |
| NEN EN ISO 14644-4 : 2001 | Identical |
| NS EN ISO 14644-4 : 1ED 2001 | Identical |
| I.S. EN ISO 14644-4:2001 | Identical |
| PN EN ISO 14644-4 : 2006 | Identical |
| AS/NZS ISO 14644.4:2002 | Identical |
| SS-EN ISO 14644-4 : 2001 | Identical |
| BS EN ISO 14644-4:2001 | Identical |
| EN ISO 14644-4:2001 | Identical |
| DIN EN ISO 14644-4:2003-06 | Identical |
| UNE-EN ISO 14644-4:2001 | Identical |
| 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 |
| 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) |
Summarise
US$96.00
Excluding Tax where applicable
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