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
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French, English
12-09-2015
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.
DevelopmentNote |
Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-1. (12/2015)
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DocumentType |
Standard
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Pages |
39
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PublisherName |
International Organization for Standardization
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Status |
Current
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Supersedes |
Standards | Relationship |
AS ISO 14644.1:2017 | Identical |
NBN EN ISO 14644-1 : 2016 | Identical |
NF EN ISO 14644-1 : 1999 | Identical |
NEN EN ISO 14644-1 : 2016 | Identical |
NS EN ISO 14644-1 : 1999 | Identical |
I.S. EN ISO 14644-1:2015 | Identical |
PN EN ISO 14644-1 : 2016 | Identical |
SN EN ISO 14644-1 : 2016 | Identical |
UNI EN ISO 14644-1 : 2001 | Identical |
UNI EN ISO 14644-1 : 2016 | Identical |
SS-EN ISO 14644-1 : 2016 | Identical |
NF EN ISO 14644-1 : 2016 | Identical |
BS EN ISO 14644-1:2015 | Identical |
UNE-EN ISO 14644-1:2016 | Identical |
EN ISO 14644-1:2015 | Identical |
DIN EN ISO 14644-1:2016-06 | Identical |
GOST ISO 14644-1 : 2002 | Identical |
GOST R ISO 14644-1 : 2000 | Identical |
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06/30155554 DC : DRAFT AUG 2006 | ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE |
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13/30283691 DC : 0 | BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
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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 |
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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 |
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NFPA 318 : 2018 | PROTECTION OF SEMICONDUCTOR FABRICATION FACILITIES |
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 ISO 16232-10:2007 | Road vehicles. Cleanliness of components of fluid circuits Expression of results |
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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) |
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CLC/TR 62258-3:2007 | Semiconductor die products - Part 3: Recommendations for good practice in handling, packing and storage |
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CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
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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 |
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EN ISO 8871-3:2004 | Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003) |
PD CLC/TR 62258-3:2007 | Semiconductor die products Recommendations for good practice in handling, packing and storage |
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ASTM F 1708 : 2002 | Standard Practice for Evaluation of Granular Polysilicon by Meter-Zoner Spectroscopies (Withdrawn 2003) |
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PD ISO/TR 18196:2016 | Nanotechnologies. Measurement technique matrix for the characterization of nano-objects |
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ISO 18933:2012 | Imaging materials Magnetic tape Care and handling practices for extended usage |
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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) |
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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 |
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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) |
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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 |
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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 |
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MIL-DTL-197 Revision N:2022 | Packaging of Bearings, Associated Parts and Subassemblies |
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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 |
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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 |
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 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 |
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 (ISO 14698-1:2003) |
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 |
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 |
UNE-EN ISO 13408-2:2011 | Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
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 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
EN ISO 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 (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 14644-14:2016 | 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 (ISO 14644-3:2005) |
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 |
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 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) |
NFPA 318:2022 | Standard for the Protection of Semiconductor Fabrication Facilities |
CLSI C38:2024 | Control of Preexamination Variation in Trace Element Determinations |
NFPA 318:2025 | Standard for the Protection of Semiconductor Fabrication Facilities |
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 |
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