• ISO 14644-1:2015

    Current The latest, up-to-date edition.

    Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  09-12-2015

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 146447.

    Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 m to 5 m are considered for classification purposes.

    The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.

    ISO 14644-1:2015 does not provide for classification 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 0,1 m) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 m).

    ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

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

    Development Note Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-1. (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)
    IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
    PD CEN ISO/TS 80004-6:2015 Nanotechnologies. Vocabulary Nano-object characterization
    06/30155554 DC : DRAFT AUG 2006 ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE
    05/30137700 DC : DRAFT AUG 2005 ISO 21501-4 - DETERMINATION OF PARTICLE SIZE DISTRIBUTION - SINGLE PARTICLE LIGHT-INTERACTION METHODS - PART 4: LIGHT-SCATTERING AIRBORNE PARTICLE COUNTER FOR CLEAN SPACES
    13/30283691 DC : 0 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED
    13/30281604 DC : 0 BS ISO 14706 - SURFACE CHEMICAL ANALYSIS - DETERMINATION OF SURFACE ELEMENTAL CONTAMINATION ON SILICON WAFERS BY TOTAL-REFLECTION X-RAY FLUORESCENCE (TXRF) SPECTROSCOPY
    BS ISO 19924:2017 Space systems. Acoustic testing
    04/30098089 DC : DRAFT APR 2004 ISO 16232-4 - ROAD VEHICLES - CLEANLINESS OF COMPONENTS OF FLUID CIRCUITS - PART 4: METHOD OF EXTRACTION OF CONTAMINANTS BY ULTRASONIC TECHNIQUES
    08/30184486 DC : DRAFT JUNE 2008 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
    BS EN 16602-70-55:2015 Space product assurance. Microbiological examination of flight hardware and cleanrooms
    BS EN 16603-20-08:2014 Space engineering Photovoltaic assemblies and components
    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    CEN ISO/TS 80004-6:2015 NANOTECHNOLOGIES - VOCABULARY - PART 6: NANO-OBJECT CHARACTERIZATION (ISO/TS 80004-6:2013)
    BS PD ISO/TS 80004-6 : 2013 NANOTECHNOLOGIES - VOCABULARY - PART 6: NANO-OBJECT CHARACTERIZATION
    I.S. CLC/TR 62258-3:2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    02/564514 DC : DRAFT OCT 2002 BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
    BS EN 16602-70-08:2015 Space product assurance. Manual soldering of high-reliability electrical connections
    04/30110525 DC : DRAFT MARCH 2004 IEC 62258-3 ED.1 - SEMICONDUCTOR DIE PRODUCTS - PART 3 - RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    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
    04/30098086 DC : DRAFT APR 2004 ISO 16232-3 - ROAD VEHICLES - CLEANLINESS OF COMPONENTS OF FLUID CIRCUITS - PART 3: METHOD OF EXTRACTION OF CONTAMINANTS BY PRESSURE RINSING
    BS EN 62258-1:2010 Semiconductor die products Procurement and use
    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 ISO 13142:2015 Electro-optical systems. Cavity ring-down technique for high-reflectance measurement
    SEMI E146 : 2006 TEST METHOD FOR THE DETERMINATION OF PARTICULATE CONTAMINATION FROM MINIENVIRONMENTS USED FOR STORAGE AND TRANSPORT OF SILICON WAFERS
    BS ISO 16232-7:2007 Road vehicles. Cleanliness of components of fluid circuits Particle sizing and counting by microscopic analysis
    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
    CSA Z10083 : 2008 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    CAN/CSA-Z5100-17 Cellulose nanomaterials - Test methods for characterization
    ISO 16232-1:2007 Road vehicles Cleanliness of components of fluid circuits Part 1: Vocabulary
    I.S. EN ISO 1135-5:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
    ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 3: Determination of released-particle count
    AAMI/ISO TIR17665-3:2014(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    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)
    I.S. EN 62258-1:2010 SEMICONDUCTOR DIE PRODUCTS - PART 1: PROCUREMENT AND USE
    ISO 20188:2018 Space systems — Product assurance requirements for commercial satellites
    BS EN ISO 7396-1:2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
    GOST ISO 14698-1 : 2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    NASA MSFC SPEC 1238 : 2007 THERMAL VACUUM BAKEOUT SPECIFICATION FOR CONTAMINATION SENSITIVE HARDWARE
    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)
    UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    ISO 18913:2012 Imaging materials Permanence Vocabulary
    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)
    UNE-EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
    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
    ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
    ASTM E 2088 : 2006 Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments
    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
    ASTM E 2088 : 2006 : R2011 Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments
    ISO 19724:2016 Gasoline engines with direct injection Cleanliness assessment of fuel injection equipment
    ASTM G 93 : 2003 : R2011 Standard Practice for Cleaning Methods and Cleanliness Levels for Material and Equipment Used in Oxygen-Enriched Environments
    NFPA 318 : 2018 PROTECTION OF SEMICONDUCTOR FABRICATION FACILITIES
    I.S. EN ISO 14644-3:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
    DIN EN ISO 14698-1 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    MIL-STD-883 Revision K:2016 TEST METHOD STANDARD - MICROCIRCUITS
    BS ISO 16232-10:2007 Road vehicles. Cleanliness of components of fluid circuits Expression of results
    BS EN ISO 13697:2006 Optics and photonics. Lasers and laser-related equipment. Test methods for specular reflectance and regular transmittance of optical laser components
    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)
    BS EN ISO 9073-10:2004 Textiles. Test methods for nonwovens Lint and other particles generation in the dry state
    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
    CLC/TR 62258-3:2007 Semiconductor die products - Part 3: Recommendations for good practice in handling, packing and storage
    DIN EN ISO 13696:2002-12 Optics and optical instruments - Test methods for radiation scattered by optical components (ISO 13696:2002)
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    EN 62258-1:2010 Semiconductor die products - Part 1: Procurement and use
    DIN EN ISO 14698-1:2004-04 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
    I.S. EN ISO 24013:2006 OPTICS AND PHOTONICS - LASERS AND LASER-RELATED EQUIPMENT - MEASUREMENT OF PHASE RETARDATION OF OPTICAL COMPONENTS FOR POLARIZED LASER RADIATION
    MIL STD 750-2 : A MECHANICAL TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 2: TEST METHODS 2001 THROUGH 2999
    ONORM 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 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    NF EN ISO 5667-23 : 2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
    06/30160058 DC : 0 BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
    10/30207686 DC : DRAFT DEC 2010 BS ISO 12345 - DIESEL ENGINES - CLEANLINESS ASSESSMENT OF FUEL INJECTION EQUIPMENT
    03/301960 DC : DRAFT MAR 2003 ISO 18933 - IMAGING MATERIALS - MAGNETIC TAPE - CARE AND HANDLING PRACTICES FOR EXTENDED USAGE
    BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    EN ISO 8871-3:2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICALS USE - PART 3: DETERMINATION OF RELEASED-PARTICLE COUNT
    PD CLC/TR 62258-3:2007 Semiconductor die products Recommendations for good practice in handling, packing and storage
    16/30337963 DC : 0 BS ISO 20437 - NATURAL RUBBER LATEX CLEANROOM GLOVES - SPECIFICATION
    ASTM F 1708 : 2002 Standard Practice for Evaluation of Granular Polysilicon by Meter-Zoner Spectroscopies (Withdrawn 2003)
    PREN ISO 14644-2 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
    ISO 4407:2002 Hydraulic fluid power — Fluid contamination — Determination of particulate contamination by the counting method using an optical microscope
    PD ISO/TR 18196:2016 Nanotechnologies. Measurement technique matrix for the characterization of nano-objects
    MIL-STD-790 Revision G:2011 ESTABLISHED RELIABILITY AND HIGH RELIABILITY QUALIFIED PRODUCTS LIST (QPL) SYSTEMS FOR ELECTRICAL, ELECTRONIC, AND FIBER OPTIC PARTS SPECIFICATIONS
    99/124125 DC : DRAFT NOV 1999 BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
    ISO 18933:2012 Imaging materials Magnetic tape Care and handling practices for extended usage
    DIN EN ISO 1135-5:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
    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 EN 16602-70-58:2015 Space product assurance. Bioburden control of cleanrooms
    DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
    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)
    14/30271334 DC : 0 BS ISO 13142 - ELECTRO-OPTICAL SYSTEMS - CAVITY RING-DOWN TECHNIQUE FOR HIGH-REFLECTANCE MEASUREMENT
    PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    02/123800 DC : DRAFT OCT 2002 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: METROLOGY AND TEST METHODS
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    14/30303657 DC : 0 BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    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)
    DIN 50451-1:2003-04 Determination of trace elements in liquids for use in semiconductor technology - Part 1: Determination of calcium, copper, gold, iron, potassium, silver and sodium in nitric acid by atomic absorption spectrometry
    DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    MIL-DTL-197 Revision M:2016 PACKAGING OF BEARINGS, ASSOCIATED PARTS AND SUBASSEMBLIES
    DIN EN ISO 1135-5 E : 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
    CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
    04/30066665 DC : DRAFT MARCH 2004 BS ISO 13408-6 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6 - ISOLATOR SYSTEMS
    BS ISO 21501-4:2007 Determination of particle size distribution. Single particle light interaction methods Light scattering airborne particle counter for clean spaces
    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
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    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 ISO 16232-3:2007 Road vehicles. Cleanliness of components of fluid circuits Method of extraction of contaminants by pressure rinsing
    ISO 13142:2015 Electro-optical systems Cavity ring-down technique for high-reflectance measurement
    S.R. CEN ISO/TS 80004-6:2015 NANOTECHNOLOGIES - VOCABULARY - PART 6: NANO-OBJECT CHARACTERIZATION (ISO/TS 80004-6:2013)
    AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    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 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    I.S. EN ISO 8871-3:2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICALS USE - PART 3: DETERMINATION OF RELEASED-PARTICLE COUNT
    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
    I.S. EN 16602-70-55:2015 SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS
    ISO 19924:2017 Space systems — Acoustic testing
    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
    BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    UNE-EN ISO 1135-5:2016 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
    I.S. EN ISO 14644-14:2016 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 14: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT BY AIRBORNE PARTICLE CONCENTRATION (ISO/DIS 14644-14)
    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)
    GOST ISO 14698-2 : 2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
    BS EN ISO 14644-15:2017 Cleanrooms and associated controlled environments Assessment of suitability for use of equipment and materials by airborne chemical concentration
    I.S. EN ISO 5667-23:2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
    I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
    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)
    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 1548 : 2009 : R2017 Standard Practice for Preparation of Aerospace Contamination Control Plans
    ASTM E 2352 : 2004 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
    UNI EN ISO 29701 : 2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    ASTM E 3059 : 2016 Standard Guide for Workforce Education in Nanotechnology Infrastructure
    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
    DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    DIN EN ISO 24013:2007-02 Optics and photonics - Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation (ISO 24013:2006)
    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
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up
    UNE-EN ISO 8536-4:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
    BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
    I.S. EN ISO 1135-4:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    I.S. EN 131-2:2010 LADDERS - PART 2: REQUIREMENTS, TESTING, MARKING
    I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    DIN EN ISO 11551:2004-05 OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD FOR ABSORPTANCE OF OPTICAL LASER COMPONENTS
    UNI 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
    I.S. EN ISO 14698-1:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    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 4066 Blatt 1:2013-05 Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
    VDI 2083 Blatt 16.2:2015-10 (Draft) Cleanroom technology - Barrier systems - Mini-environments
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    MIL-DTL-197 Revision N:2022 Packaging of Bearings, Associated Parts and Subassemblies
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI/VDE 2627 Blatt 1:2015-12 Measuring rooms - Classification and characteristics - Planning and execution
    VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
    VDI 2083 Blatt 13.1:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
    VDI/VDE 3516 Blatt 2:1981-07 Process analytical equipment for fluids
    VDI 3455:2013-08 Emission control - High-volume car body painting plants
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
    VDI 2119:2013-06 Ambient air measurements - Sampling of atmospheric particles > 2,5 ?m on an acceptor surface using the Sigma-2 passive sampler - Characterisation by optical microscopy and calculation of number settling rate and mass concentration
    04/30098170 DC : DRAFT APR 2004 ISO 16232-10 - ROAD VEHICLES - FLUID CIRCUITS - CLEANLINESS OF COMPONENTS - PART 10: EXPRESSION OF RESULTS
    UNE-EN ISO 14644-14:2017 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
    BS ISO 20437:2017 Natural rubber latex cleanroom gloves. Specification
    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
    BS ISO 16232-6:2007 Road vehicles. Cleanliness of components of fluid circuits Particle mass determination by gravimetric analysis
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    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
    07/30172614 DC : 0 BS ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE
    BS ISO 18913:2012 Imaging materials. Permanence. Vocabulary
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    04/19987843 DC : DRAFT OCT 2004 BS ISO 13697 - OPTICS AND PHOTONICS - LASERS AND LASER-RELATED EQUIPMENT - TEST METHODS FOR SPECULAR REFLECTANCE AND TRANSMITTANCE OF OPTICAL LASER COMPONENTS
    10/30152881 DC : DRAFT DEC 2010 BS EN ISO 14644-2 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
    UNI EN ISO 5667-23 : 2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
    13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
    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
    04/30098096 DC : DRAFT APR 2004 ISO 16232-6 - ROAD VEHICLES - CLEANLINESS OF COMPONENTS OF FLUID CIRCUITS - PART 6: GRAVIMETRIC ANALYSIS
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    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
    16/30303345 DC : DRAFT JAN 2016 BS ISO 19724 - GASOLINE ENGINES WITH DIRECT INJECTION - CLEANLINESS ASSESSMENT OF FUEL INJECTION EQUIPMENT
    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
    BS ISO 4407:2002 Hydraulic fluid power. Fluid contamination. Determination of particulate contamination by the counting method using an optical microscope
    BS ISO 16232-4:2007 Road vehicles. Cleanliness of components of fluid circuits Method of extraction of contaminants by ultrasonic techniques
    ASTM F 1724 : 2001 Standard Test Method for Measuring Surface Metal Contamination of Polycrystalline Silicon by Acid Extraction-Atomic Absorption Spectroscopy (Withdrawn 2003)
    UNE-EN 16372:2015 Aesthetic surgery services
    12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
    DIN EN ISO 13408-2:2011-09 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    BWB TL 6505-0488 : 1ED 2009 MEDICAL OXYGEN - 93% - GENERAL CONDITIONS
    AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    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
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    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
    I.S. EN 16603-20-08:2014 SPACE ENGINEERING - PART 20-08: PHOTOVOLTAIC ASSEMBLIES AND COMPONENTS
    UNI EN ISO 13408-2 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces
    DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    ISO 16232-7:2007 Road vehicles Cleanliness of components of fluid circuits Part 7: Particle sizing and counting by microscopic analysis
    BS ISO 18413:2015 Hydraulic fluid power. Cleanliness of components. Inspection document and principles related to contaminant extraction and analysis, and data reporting
    ISO 16232-10:2007 Road vehicles Cleanliness of components of fluid circuits Part 10: Expression of results
    ASTM E 2088 : 2006 : R2015 Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments
    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
    ASTM F 25 : 2004 Standard Test Method for Sizing and Counting Airborne Particulate Contamination in Cleanrooms and Other Dust-Controlled Areas
    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
    ISO 17331:2004 Surface chemical analysis Chemical methods for the collection of elements from the surface of silicon-wafer working reference materials and their determination by total-reflection X-ray fluorescence (TXRF) spectroscopy
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    ISO 14706:2014 Surface chemical analysis Determination of surface elemental contamination on silicon wafers by total-reflection X-ray fluorescence (TXRF) spectroscopy
    BS EN ISO 11551:2003 Optics and optical instruments. Lasers and laser-related equipment. Test method for absorptance of optical laser components
    ISO 15388:2012 Space systems — Contamination and cleanliness control
    DIN EN ISO 14698-2 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    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)
    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)
    ISO 1135-5:2015 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
    BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control Evaluation and interpretation of biocontamination data
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    UNI EN ISO 8536-4 : 2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
    BS EN ISO 1135-4:2015 Transfusion equipment for medical use Transfusion sets for single use, gravity feed
    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
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    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
    I.S. EN ISO 9073-10:2005 TEXTILES - TEST METHODS FOR NONWOVENS - PART 10: LINT AND OTHER PARTICLES GENERATION IN THE DRY STATE
    NASA MSFC STD 246 : 2011 STANDARD DESIGN AND OPERATIONAL CRITERIA FOR CONTROLLED ENVIRONMENTAL AREAS
    I.S. EN ISO 14698-2:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    NASA PRC 5001 : 2011 PROCESS SPECIFICATION FOR CLEANING OF HARDWARE
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    EN ISO 29701 : 2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
    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 16602-70-55:2015 Space product assurance - Microbiological examination of flight hardware and cleanrooms
    I.S. EN ISO 13696:2002 OPTICS AND OPTICAL INSTRUMENTS - TEST METHODS FOR RADIATION SCATTERED BY OPTICAL COMPONENTS
    DIN EN ISO 14644-13 E : 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 12345:2013 Diesel engines Cleanliness assessment of fuel injection equipment
    05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
    17/30319520 DC : 0 BS ISO 20289 - SURFACE CHEMICAL ANALYSIS - TOTAL REFLECTION X-RAY FLUORESCENCE ANALYSIS OF WATER SAMPLES
    02/122627 DC : DRAFT JULY 2002 BS ISO 17331 - SURFACE CHEMICAL ANALYSIS - CHEMICAL METHODS FOR THE COLLECTION OF ELEMENTS FROM THE SURFACE OF SILICON-WAFER WORKING-REFERENCE MATERIALS AND THEIR DETERMINATION BY TOTAL-REFLECTION X-RAY FLUORESCENCE SPECTROSCOPY (TXRF)
    I.S. EN 14091:2002 SPACE PRODUCT ASSURANCE - THERMAL VACUUM OUTGASSING TEST FOR THE SCREENING OF SPACE MATERIALS
    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
    11/30205822 DC : 0 BS ISO 18913 - IMAGING MATERIALS - PERMANENCE - VOCABULARY
    AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    16/30299911 DC : 0 BS ISO 21501-4 - DETERMINATION OF PARTICLE SIZE DISTRIBUTION - SINGLE PARTICLE LIGHT INTERACTION METHODS - PART 4: LIGHT SCATTERING AIRBORNE PARTICLE COUNTER FOR CLEAN SPACES
    I.S. EN 14777:2004 SPACE ENGINEERING - MULTIPACTION DESIGN AND TEST
    BS EN ISO 29701:2010 Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
    BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
    DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    DIN EN ISO 1135-3 E : 2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    BS ISO 12345:2013 Diesel engines. Cleanliness assessment of fuel injection equipment
    13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    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
    17/30302489 DC : DRAFT MAR 2017 BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    05/30105136 DC : DRAFT APR 2005 ISO 24013 - OPTICS AND PHOTONICS - LASERS AND LASER RELATED EQUIPMENT - MEASUREMENT OF OPTICAL PHASE SHIFT OF OPTICAL COMPONENTS
    EN ISO 13408-6:2011/A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
    UNE-EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
    16/30348371 DC : 0 BS ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: SPECIFICATIONS FOR MONITORING AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION
    08/30190157 DC : DRAFT SEP 2008 BS EN ISO 14644-9 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 9: CLASSIFICATION OF SURFACE PARTICLE CLEANLINESS
    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
    UNI EN ISO 14644-10 : 2013 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 10: CLASSIFICATION OF SURFACE CLEANLINESS BY CHEMICAL CONCENTRATION
    I.S. EN 16602-70-08:2015 SPACE PRODUCT ASSURANCE - MANUAL SOLDERING OF HIGH-RELIABILITY ELECTRICAL CONNECTIONS
    07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    BS ISO 14706:2014 Surface chemical analysis. Determination of surface elemental contamination on silicon wafers by total-reflection X-ray fluorescence (TXRF) spectroscopy
    09/30175345 DC : 0 BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
    17/30311287 DC : 0 BS ISO 19924 - SPACE SYSTEMS - ACOUSTIC TESTING
    00/705381 DC : DRAFT FEB 2000 ISO/CD 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
    BS ISO 16232-2:2007 Road vehicles. Cleanliness of components of fluid circuits Method of extraction of contaminants by agitation
    AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    02/564513 DC : DRAFT OCT 2002 BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
    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
    01/560508 DC : DRAFT FEB 2001 BS ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    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
    ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    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)
    UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    BS ISO 17331 : 2004 SURFACE CHEMICAL ANALYSIS - CHEMICAL METHODS FOR THE COLLECTION OF ELEMENTS FROM THE SURFACE OF SILICON-WAFER WORKING REFERENCE MATERIALS AND THEIR DETERMINATION BY TOTAL-REFLECTION X-RAY FLUORESCENCE (TXRF) SPECTROSCOPY
    AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    I.S. EN ISO 1135-3:2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    ISO 16232-2:2007 Road vehicles Cleanliness of components of fluid circuits Part 2: Method of extraction of contaminants by agitation
    ISO 20437:2017 Natural rubber latex cleanroom gloves — Specification
    S.R. CEN/TS 16244:2018 VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
    ASTM F 3218 : 2017 Standard Practice for Recording Environmental Effects for Utilization with A-UGV Test Methods
    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
    ASTM F 25/F25M : 2009 Standard Test Method for Sizing and Counting Airborne Particulate Contamination in Cleanrooms and Other Dust-Controlled Areas
    ASTM G 93 : 2003 : EDT 1 Standard Practice for Cleaning Methods and Cleanliness Levels for Material and Equipment Used in Oxygen-Enriched Environments
    UNE-EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    I.S. EN ISO 11551:2004 OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD FOR ABSORPTANCE OF OPTICAL LASER COMPONENTS
    I.S. EN ISO 24998:2008 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    ISO/TR 18196:2016 Nanotechnologies — Measurement technique matrix for the characterization of nano-objects
    ISO 18938:2014 Imaging materials — Optical discs — Care and handling for extended storage
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    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)
    IEC TR 62258-3:2010 Semiconductor die products - Part 3: Recommendations for good practice in handling, packing and storage
    I.S. EN ISO 8536-4:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010)
    BS EN ISO 8536-4 : 2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
    DIN EN ISO 8536-4:2013-07 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013)
    UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
    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 11551:2003 Optics and optical instruments Lasers and laser-related equipment Test method for absorptance of optical laser components
    BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments Operations
    ISO 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
    ISO/TS 80004-6:2013 Nanotechnologies Vocabulary Part 6: Nano-object characterization
    ISO 13696:2002 Optics and optical instruments Test methods for radiation scattered by optical components
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 14644-14:2016 Cleanrooms and associated controlled environments Part 14: Assessment of suitability for use of equipment by airborne particle concentration
    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 131-2 : 2010 LADDERS - PART 2: REQUIREMENTS, TESTING, MARKING
    BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments Test methods
    BS EN ISO 13696:2002 Optics and optical instruments. Test methods for radiation scattered by optical components
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    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)
    ISO 13697:2006 Optics and photonics Lasers and laser-related equipment Test methods for specular reflectance and regular transmittance of optical laser components
    BS EN ISO 24013:2006 Optics and photonics. Lasers and laser-related equipment. Measurement of phase retardation of optical components for polarized laser radiation
    ISO 9073-10:2003 Textiles Test methods for nonwovens Part 10: Lint and other particles generation in the dry state
    EN ISO 24013:2006 Optics and photonics - Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation (ISO 24013:2006)
    EN 14777:2004 Space engineering - Multipaction design and test
    EN 16372:2014 Aesthetic surgery services
    EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
    EN ISO 11551:2003 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components (ISO 11551:2003)
    EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    EN ISO 5667-23:2011 Water quality - Sampling - Part 23: Guidance on passive sampling in surface waters (ISO 5667-23:2011)
    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 14644-10:2013 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 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 14644-14:2016 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
    EN 14091:2002 Space product assurance - Thermal vacuum outgassing test for the screening of space materials
    EN ISO 13696:2002 Optics and optical instruments - Test methods for radiation scattered by optical components (ISO 13696:2002)
    EN ISO 13697:2006 Optics and photonics - Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components (ISO 13697:2006)
    EN ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
    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
    EN ISO 9073-10:2004 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003)
    EN 16603-20-08:2014 Space engineering - Part 20-08: Photovoltaic assemblies and components
    EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    EN 16602-70-08:2015 Space product assurance - Manual soldering of high-reliability electrical connections
    DIN ISO 10083:2008-12 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
    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)
    13/30261893 DC : 0 BS EN ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: CLASSIFICATION OF AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION
    BS EN ISO 5667-23:2011 Water quality. Sampling Guidance on passive sampling in surface waters
    BS PD IEC TR 62258-3 : 2005 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    MIL-STD-648 Revision E:2016 Specialized Shipping Containers
    BS ISO 19724:2016 Gasoline engines with direct injection. Cleanliness assessment of fuel injection equipment
    UNE-EN ISO 14644-10:2014 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013)
    BS EN 16372:2014 Aesthetic surgery services
    BS EN ISO 1135-5:2015 Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus
    MIL-STD-750-5 Base Document:2012 HIGH RELIABILITY SPACE APPLICATION TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 5: TEST METHODS 5000 THROUGH 5999
    BS EN ISO 1135-3:2017 Transfusion equipment for medical use Blood-taking sets for single use
    AES 49 : 2005(R2010)
    BS ISO 16232-1:2007 Road vehicles. Cleanliness of components of fluid circuits Vocabulary
    DIN EN ISO 5667-23 E : 2011 WATER QUALITY - SAMPLING - PART 23: GUIDANCE ON PASSIVE SAMPLING IN SURFACE WATERS
    I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    DIN 50451-2:2003-04 Determination of trace elements in liquids for use in semiconductor technology - Part 2: Determination of calcium, chromium, cobalt, copper, iron, nickel and zinc in hydrofluoric acid by plasma emission spectroscopy
    DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
    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
    CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    BS IEC 61340-5.1 : 1998 AMD 13198 ELECTROSTATICS - PART 5-1: PROTECTION OF ELECTRONIC DEVICES FROM ELECTROSTATIC PHENOMENA - GENERAL REQUIREMENTS
    13/30283694 DC : 0 BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
    BS EN ISO 14644-14:2016 ENISO 14644-14 environments — Assessment of suitability of equipment and materials for cleanrooms Assessment of suitability for use of equipment by airborne particle concentration
    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 Z10083 : 2008 : R2013 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    04/30098083 DC : DRAFT APR 2004 ISO 16232-2 - ROAD VEHICLES - FLUID CIRCUITS - CLEANLINESS OF COMPONENTS - PART 2: METHOD OF EXTRACTION OF CONTAMINANTS BY AGITATION
    AAMI ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    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
    CSA Z5100/Z5200 PACKAGE : 2017 CONSISTS OF Z5100-17, CELLULOSE NANOMATERIALS - TEST METHODS FOR CHARACTERIZATION AND Z5200-17, CELLULOSE NANOMATERIALS - BLANK DETAIL SPECIFICATION
    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
    CEN/TS 16244:2018 Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    ASTM E 2614 : 2015 : REDLINE Standard Guide for Evaluation of Cleanroom Disinfectants
    ISO 14644-15:2017 Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
    CEI CLC/TR 62258-3 : 2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
    ISO/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    16/30341759 DC : 0 BS EN 16602-70-54 - SPACE PRODUCT ASSURANCE - ULTRACLEANING OF FLIGHT HARDWARE
    UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    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
    ISO 16232-3:2007 Road vehicles Cleanliness of components of fluid circuits Part 3: Method of extraction of contaminants by pressure rinsing
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    ISO 18413:2015 Hydraulic fluid power Cleanliness of components Inspection document and principles related to contaminant extraction and analysis, and data reporting
    ISO 16232-4:2007 Road vehicles Cleanliness of components of fluid circuits Part 4: Method of extraction of contaminants by ultrasonic techniques
    ASTM F 25/F25M : 2009 : R2015 Standard Test Method for Sizing and Counting Airborne Particulate Contamination in Cleanrooms and Other Dust-Controlled Areas
    ISO 16232-6:2007 Road vehicles Cleanliness of components of fluid circuits Part 6: Particle mass determination by gravimetric analysis
    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 9073-10 E : 2005 TEXTILES - TEST METHODS FOR NONWOVENS - PART 10: LINT AND OTHER PARTICLES GENERATION IN THE DRY STATE
    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
    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)
    IEC 62258-1:2009 Semiconductor die products - Part 1: Procurement and use
    ISO 5667-23:2011 Water quality Sampling Part 23: Guidance on passive sampling in surface waters
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    BS EN 14091:2002 Space product assurance. Thermal vacuum outgassing test for the screening of space materials
    BS EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceuticals use Determination of released-particle count
    BS EN 14777:2004 Space engineering. Multipaction design and test
    ISO 29701:2010 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test
    ISO 24013:2006 Optics and photonics — Lasers and laser-related equipment — Measurement of phase retardation of optical components for polarized laser radiation
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    CEI EN 62258-1 : 2011 SEMICONDUCTOR DIE PRODUCTS - PART 1: PROCUREMENT AND USE
    EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    DIN EN ISO 14698-2:2004-02 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)
    DIN EN ISO 9073-10:2005-03 TEXTILES - TEST METHODS FOR NONWOVENS - PART 10: LINT AND OTHER PARTICLES GENERATION IN THE DRY STATE
    DIN EN ISO 5667-23:2011-06 Water quality - Sampling - Part 23: Guidance on passive sampling in surface waters (ISO 5667-23:2011)
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    DIN EN ISO 13697:2006-08 Optics and photonics - Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components (ISO 13697:2006)
    EN 131-2:2010+A2:2017 Ladders - Part 2: Requirements, testing, marking
    DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    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
    CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)

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

    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
    IEST G CC1004 : 1999 SEQUENTIAL-SAMPLING PLAN FOR USE IN CLASSIFICATION OF THE PARTICULATE CLEANLINESS OF AIR IN CLEANROOMS AND CLEAN ZONES
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    IEST G CC1003 : 1999 MEASUREMENT OF AIRBORNE MACROPARTICLES
    ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective