ISO 14644-2:2015
Current
Current
The latest, up-to-date edition.
Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
09-12-2015
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ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 m to 5 m. Concentrations of ultrafine particles (particles smaller than 0,1m) will be addressed in a separate standard.
| DevelopmentNote |
Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-2. (12/2015)
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| DocumentType |
Standard
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| Pages |
14
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| ABNT NBR ISO 14644-2:2019 | Identical |
| AS ISO 14644.2:2017 | Identical |
| NBN EN ISO 14644-2 : 2016 | Identical |
| NF EN ISO 14644-2 : 2016 | Identical |
| NEN EN ISO 14644-2 : 2016 | Identical |
| NS EN ISO 14644-2 : 2000 | Identical |
| I.S. EN ISO 14644-2:2015 | Identical |
| PN EN ISO 14644-2 : 2016 | Identical |
| SN EN ISO 14644-2 : 2016 | Identical |
| UNI EN ISO 14644-2 : 2016 | Identical |
| SS-EN ISO 14644-2 : 2016 | Identical |
| BS EN ISO 14644-2:2015 | Identical |
| UNE-EN ISO 14644-2:2016 | Identical |
| EN ISO 14644-2:2015 | Identical |
| GOST R ISO 14644-2 : 2001 | Identical |
| DIN EN ISO 14644-2:2016-05 | Identical |
| UNI EN ISO 14644-2 : 2001 | Identical |
| NBR ISO 14644-2 : 2006 | Identical |
| GOST R ISO 14644-2 : 2020 | Identical |
| DIN EN ISO 29701:2011-01 | Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) |
| 06/30155554 DC : DRAFT AUG 2006 | ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE |
| BS EN 16602-70-55:2015 | Space product assurance. Microbiological examination of flight hardware and cleanrooms |
| I.S. EN 13824:2005 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| ISO 18933:2012 | Imaging materials Magnetic tape Care and handling practices for extended usage |
| 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 ISO 18938:2014 | Imaging materials. Optical discs. Care and handling for extended storage |
| 07/19969755 DC : 0 | BS ISO 11500 - HYDRAULIC FLUID POWER - DETERMINATION OF PARTICULATE CONTAMINATION LEVEL OF A LIQUID SAMPLE BY AUTOMATIC PARTICLE COUNTING USING THE LIGHT EXTINCTION PRINCIPLE |
| MIL-STD-750-3 Base Document:2012 | Transistor Electrical Test Methods for Semiconductor Devices Part 3: Test Methods 3000 Through 3999 |
| ASTM E 2311 : 2004 : R2016 | Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space |
| AAMI ISO 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 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) |
| I.S. EN 16602-70-58:2015 | SPACE PRODUCT ASSURANCE - BIOBURDEN CONTROL OF CLEANROOMS |
| 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) |
| NASA MSFC SPEC 1238 : 2007 | THERMAL VACUUM BAKEOUT SPECIFICATION FOR CONTAMINATION SENSITIVE HARDWARE |
| ASTM E 1549/E1549M : 2013 | Standard Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for Non-Hazardous and Hazardous Operations |
| ASTM E 2217 : 2012 : REDLINE | Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas |
| ASTM F 2332 : 2006 | Standard Specification for Annular Ball Bearings for Instruments and Precision Rotating Components |
| ASTM F 2444 : 2004 | Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques |
| I.S. EN ISO 14644-3:2006 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS |
| MIL-STD-883 Revision K:2016 | TEST METHOD STANDARD - MICROCIRCUITS |
| 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) |
| UNE-EN ISO 14644-1:2016 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| BS EN 13824:2004 | Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| MIL STD 750-2 : A | MECHANICAL TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 2: TEST METHODS 2001 THROUGH 2999 |
| 03/301960 DC : DRAFT MAR 2003 | ISO 18933 - IMAGING MATERIALS - MAGNETIC TAPE - CARE AND HANDLING PRACTICES FOR EXTENDED USAGE |
| BS EN 16602-70-58:2015 | Space product assurance. Bioburden control of cleanrooms |
| AAMI TIR52 : 2014(R2017) | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| 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 |
| ASTM E 2311 : 2004 | Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space |
| 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) |
| MIL-DTL-197 Revision M:2016 | PACKAGING OF BEARINGS, ASSOCIATED PARTS AND SUBASSEMBLIES |
| BS ISO 18933:2012 | Imaging materials. Magnetic tape. Care and handling practices for extended usage |
| ASTM E 2090 : 2012 : REDLINE | Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy |
| MIL-DTL-24784-7 Revision D:2017 | Technical Repair Standards (TRS) for Hull, Mechanical, and Electrical (HM&E) Equipment, Electronic Equipment, and Ordnance Equipment |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| I.S. EN 16602-70-55:2015 | SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS |
| ASTM E 2352 : 2019 | Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations |
| ASTM E 2042 : 2004 | Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms |
| ASTM E 2352 : 2004 | Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations |
| ASTM E 1548 : 2009 : R2017 | Standard Practice for Preparation of Aerospace Contamination Control Plans |
| UNI EN ISO 29701 : 2010 | NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
| ASTM E 1548 : 2009 | Standard Practice for Preparation of Aerospace Contamination Control Plans |
| ASTM E 2042/E2042M : 2009 | Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms |
| ASTM F 50 : 2012 : R2015 | Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles |
| CAN/CSA-Z317.13-17 | Infection control during construction, renovation, and maintenance of health care facilities |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments Part 6: Vocabulary |
| BS EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments Design, construction and start-up |
| I.S. EN ISO 14644-6:2007 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| MIL-DTL-197 Revision N:2022 | Packaging of Bearings, Associated Parts and Subassemblies |
| 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 |
| VDI 2083 Blatt 3:2005-07 | Cleanroom technology - Metrology and test methods |
| VDI 2083 Blatt 16.1:2010-08 | Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification |
| VDI 2083 Blatt 5.1:2007-09 | Cleanroom technology - Cleanroom operation |
| 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) |
| ASTM F 2444 : 2004 : R2018 | Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques |
| 16/30326493 DC : 0 | BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS |
| 07/30172614 DC : 0 | BS ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| ASTM E 2311 : 2004 : R2009 | Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space |
| 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 |
| ISO/IEC TS 22237-4:2018 | Information technology Data centre facilities and infrastructures Part 4: Environmental control |
| 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 |
| ASTM F 2444 : 2004 : R2012 | Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques |
| 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 11500:2008 | Hydraulic fluid power — Determination of the particulate contamination level of a liquid sample by automatic particle counting using the light-extinction principle |
| ISO 21501-4:2007 | Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces |
| ASTM E 1549/E1549M : 2013 : R2016 | Standard Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for Non-Hazardous and Hazardous Operations |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| 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 14644-1:2016-06 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| NASA RPTSTD 8070 0001 : 2010 CHANGE 2 2013 | SURFACE CLEANLINESS STANDARD OF FLUID SYSTEMS FOR ROCKET ENGINE TEST FACILITIES OF THE NASA ROCKET PROPULSION TEST PROGRAM |
| NASA KSC C 123 : 2009 | SURFACE CLEANLINESS OF GROUND SUPPORT EQUIPMENT FLUID SYSTEMS, SPECIFICATION FOR |
| NASA PRC 5001 : 2011 | PROCESS SPECIFICATION FOR CLEANING OF HARDWARE |
| EN ISO 29701:2010 | Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) |
| EN 16602-70-55:2015 | Space product assurance - Microbiological examination of flight hardware and cleanrooms |
| 05/30142385 DC : DRAFT NOV 2005 | ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| I.S. EN ISO 29701:2010 | NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
| MIL-PRF-38535 Revision K:2013 | Integrated Circuits (Microcircuits) Manufacturing, General Specification for |
| BS EN ISO 29701:2010 | Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test |
| DIN EN ISO 24998:2009-03 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| IEC/IEEE 62659:2015 | Nanomanufacturing - Large scale manufacturing for nanoelectronics |
| MIL-STD-790 Revision G:2011 | Established Reliability and High Reliability Qualified Products List (QPL) Systems for Electrical, Electronic, and Fiber Optic Parts Specifications |
| SAE ARP1176A | Oxygen System and Component Cleaning |
| BS ISO 11500:2008 | Hydraulic fluid power. Determination of the particulate contamination level of a liquid sample by automatic particle counting using the light-extinction principle |
| 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 |
| 13/30281524 DC : 0 | BS ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE |
| 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 |
| 09/30175345 DC : 0 | BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
| 00/705381 DC : DRAFT FEB 2000 | ISO/CD 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL |
| CSA ISO TR 14969 : 2005 : R2015 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI TIR52 : 2014 | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| 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 |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| CSA ISO TR 14969 :2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| ASTM E 2042/E2042M : 2009 : R2016 | Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms |
| ASTM F 2332 : 2006 : R2013 | Standard Specification for Annular Ball Bearings for Instruments and Precision Rotating Components |
| ASTM E 1235 : 2012 : REDLINE | Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft |
| I.S. EN ISO 24998:2008 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| ISO 18938:2014 | Imaging materials — Optical discs — Care and handling for extended storage |
| 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) |
| BS EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments Operations |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| BS EN ISO 14644-3:2005 | Cleanrooms and associated controlled environments Test methods |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| BS EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration |
| 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 14644-1:2015 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN 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 16602-70-58:2015 | Space product assurance - Bioburden control of cleanrooms |
| EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
| EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| EN ISO 14644-3:2005 | Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005) |
| EN 13824:2004 | Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| MIL-STD-648 Revision E:2016 | Specialized Shipping Containers |
| MIL-STD-750-5 Base Document:2012 | HIGH RELIABILITY SPACE APPLICATION TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 5: TEST METHODS 5000 THROUGH 5999 |
| AES 49 : 2005(R2010) | |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| MIL-PRF-38534 Revision K:2017 | HYBRID MICROCIRCUITS, GENERAL SPECIFICATION FOR |
| 04/30079743 DC : DRAFT APR 2004 | ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 17/30329441 DC : 0 | BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| CSA ISO TR 14969 : 2005 : R2010 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| ASTM E 1234 : 2012 : REDLINE | Standard Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally Controlled Areas for Spacecraft |
| ISO 24998:2008 | Plastics laboratory ware — Single-use Petri dishes for microbiological procedures |
| UNE 171340:2012 | Validation and evaluation of controlled environment rooms in hospitals |
| UNI EN ISO 24998 : 2009 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| ASTM F 50 : 2012 | Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles |
| ASTM A 380/A380M : 2017 | Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems |
| ASTM E 2352 : 2004 : R2010 | Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations |
| 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 |
| ISO 29701:2010 | Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test |
| DIN EN 13824:2005-02 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| 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 |
| 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 31000:2009 | Risk management Principles and guidelines |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO 21501-4:2007 | Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces |
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