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ISO 14644-1:2015

Current
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

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)
DocumentType
Standard
Pages
39
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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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)

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 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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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