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  • ISO 14644-2:2015

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    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

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-2. (12/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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 (published 2010-03) 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 : 0 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 : K TEST METHOD STANDARD - MICROCIRCUITS
    BS EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: 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)
    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 : M 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 : D TECHNICAL REPAIR STANDARDS (TRS) FOR HULL, MECHANICAL, AND ELECTRICAL (HM&E) EQUIPMENT, ELECTRONIC EQUIPMENT, AND ORDNANCE EQUIPMENT
    BS EN ISO 13408-1:2015 (published 2015-08) 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 2083-15 : 2007 CLEANROOM TECHNOLOGY - PERSONNEL AT THE CLEAN WORK PLACE
    MIL-DTL-197N:2022 Packaging of Bearings, Associated Parts and Subassemblies
    VDI 2083-8-1 : 2014 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083-1 : 2013 CLEANROOM TECHNOLOGY - PARTICULATE AIR CLEANLINESS CLASSES
    VDI 2083-3 : 2005 CLEANROOM TECHNOLOGY - METROLOGY AND TEST METHODS
    VDI 2083 Blatt 16.1:2010-08 CLEANROOM TECHNOLOGY - BARRIER 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 : K 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 : G ESTABLISHED RELIABILITY AND HIGH RELIABILITY QUALIFIED PRODUCTS LIST (QPL) SYSTEMS FOR ELECTRICAL, ELECTRONIC, AND FIBER OPTIC PARTS SPECIFICATIONS
    ARP1176A : 2013(R2018) 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 - PART 3: 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
    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 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
    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
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    MIL STD 648 : E SPECIALIZED SHIPPING CONTAINERS
    MIL STD 750-5 : 0 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 : K 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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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