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ISO 14644-2:2015

Current
Current

The latest, up-to-date edition.

Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

09-12-2015

ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.

ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 m to 5 m. Concentrations of ultrafine particles (particles smaller than 0,1m) will be addressed in a separate standard.

DevelopmentNote
Supersedes FED STD 209 (03/2002) Supersedes ISO/DIS 14644-2. (12/2015)
DocumentType
Standard
Pages
14
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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06/30155554 DC : DRAFT AUG 2006 ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE
BS EN 16602-70-55:2015 Space product assurance. Microbiological examination of flight hardware and cleanrooms
I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
ISO 18933:2012 Imaging materials Magnetic tape Care and handling practices for extended usage
14/30287226 DC : 0 BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
BS ISO 18938:2014 Imaging materials. Optical discs. Care and handling for extended storage
07/19969755 DC : 0 BS ISO 11500 - HYDRAULIC FLUID POWER - DETERMINATION OF PARTICULATE CONTAMINATION LEVEL OF A LIQUID SAMPLE BY AUTOMATIC PARTICLE COUNTING USING THE LIGHT EXTINCTION PRINCIPLE
MIL-STD-750-3 Base Document:2012 Transistor Electrical Test Methods for Semiconductor Devices Part 3: Test Methods 3000 Through 3999
ASTM E 2311 : 2004 : R2016 Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space
AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
UNE-EN ISO 15378:2016 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
I.S. EN 16602-70-58:2015 SPACE PRODUCT ASSURANCE - BIOBURDEN CONTROL OF CLEANROOMS
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
NASA MSFC SPEC 1238 : 2007 THERMAL VACUUM BAKEOUT SPECIFICATION FOR CONTAMINATION SENSITIVE HARDWARE
ASTM E 1549/E1549M : 2013 Standard Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for Non-Hazardous and Hazardous Operations
ASTM E 2217 : 2012 : REDLINE Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
ASTM F 2332 : 2006 Standard Specification for Annular Ball Bearings for Instruments and Precision Rotating Components
ASTM F 2444 : 2004 Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques
I.S. EN ISO 14644-3:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
MIL-STD-883 Revision K:2016 TEST METHOD STANDARD - MICROCIRCUITS
BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments Vocabulary
ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
UNE-EN ISO 14644-1:2016 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
MIL STD 750-2 : A MECHANICAL TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 2: TEST METHODS 2001 THROUGH 2999
03/301960 DC : DRAFT MAR 2003 ISO 18933 - IMAGING MATERIALS - MAGNETIC TAPE - CARE AND HANDLING PRACTICES FOR EXTENDED USAGE
BS EN 16602-70-58:2015 Space product assurance. Bioburden control of cleanrooms
AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
BS ISO 15378 : 2006 AMD 17315 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
02/123800 DC : DRAFT OCT 2002 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: METROLOGY AND TEST METHODS
ASTM E 2311 : 2004 Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space
DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
MIL-DTL-197 Revision M:2016 PACKAGING OF BEARINGS, ASSOCIATED PARTS AND SUBASSEMBLIES
BS ISO 18933:2012 Imaging materials. Magnetic tape. Care and handling practices for extended usage
ASTM E 2090 : 2012 : REDLINE Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy
MIL-DTL-24784-7 Revision D:2017 Technical Repair Standards (TRS) for Hull, Mechanical, and Electrical (HM&E) Equipment, Electronic Equipment, and Ordnance Equipment
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
I.S. EN 16602-70-55:2015 SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS
ASTM E 2352 : 2019 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
ASTM E 2042 : 2004 Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
ASTM E 2352 : 2004 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
ASTM E 1548 : 2009 : R2017 Standard Practice for Preparation of Aerospace Contamination Control Plans
UNI EN ISO 29701 : 2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
ASTM E 1548 : 2009 Standard Practice for Preparation of Aerospace Contamination Control Plans
ASTM E 2042/E2042M : 2009 Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
ASTM F 50 : 2012 : R2015 Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles
CAN/CSA-Z317.13-17 Infection control during construction, renovation, and maintenance of health care facilities
ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up
I.S. EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
MIL-DTL-197 Revision N:2022 Packaging of Bearings, Associated Parts and Subassemblies
VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
ASTM F 2444 : 2004 : R2018 Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques
16/30326493 DC : 0 BS EN ISO 14644-3 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
07/30172614 DC : 0 BS ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE
I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
ASTM E 2311 : 2004 : R2009 Standard Practice for QCM Measurement of Spacecraft Molecular Contamination in Space
BS ISO 15388:2012 Space systems. Contamination and cleanliness control
BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ISO/IEC TS 22237-4:2018 Information technology Data centre facilities and infrastructures Part 4: Environmental control
BS ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
ASTM F 2444 : 2004 : R2012 Standard Practice for Damage Prevention of Bearings, and Bearing Components Through Proper Handling Techniques
ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
ISO 11500:2008 Hydraulic fluid power — Determination of the particulate contamination level of a liquid sample by automatic particle counting using the light-extinction principle
ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces
ASTM E 1549/E1549M : 2013 : R2016 Standard Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for Non-Hazardous and Hazardous Operations
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 15388:2012 Space systems — Contamination and cleanliness control
DIN EN ISO 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
NASA RPTSTD 8070 0001 : 2010 CHANGE 2 2013 SURFACE CLEANLINESS STANDARD OF FLUID SYSTEMS FOR ROCKET ENGINE TEST FACILITIES OF THE NASA ROCKET PROPULSION TEST PROGRAM
NASA KSC C 123 : 2009 SURFACE CLEANLINESS OF GROUND SUPPORT EQUIPMENT FLUID SYSTEMS, SPECIFICATION FOR
NASA PRC 5001 : 2011 PROCESS SPECIFICATION FOR CLEANING OF HARDWARE
EN ISO 29701 : 2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
EN 16602-70-55:2015 Space product assurance - Microbiological examination of flight hardware and cleanrooms
05/30142385 DC : DRAFT NOV 2005 ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
I.S. EN ISO 29701:2010 NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
MIL-PRF-38535 Revision K:2013 Integrated Circuits (Microcircuits) Manufacturing, General Specification for
BS EN ISO 29701:2010 Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
IEC/IEEE 62659:2015 Nanomanufacturing - Large scale manufacturing for nanoelectronics
MIL-STD-790 Revision G:2011 ESTABLISHED RELIABILITY AND HIGH RELIABILITY QUALIFIED PRODUCTS LIST (QPL) SYSTEMS FOR ELECTRICAL, ELECTRONIC, AND FIBER OPTIC PARTS SPECIFICATIONS
ARP1176A : 2013(R2018) OXYGEN SYSTEM AND COMPONENT CLEANING
BS ISO 11500:2008 Hydraulic fluid power. Determination of the particulate contamination level of a liquid sample by automatic particle counting using the light-extinction principle
BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
14/30289934 DC : 0 BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES
13/30281524 DC : 0 BS ISO 18938 - IMAGING MATERIALS - OPTICAL DISCS - CARE AND HANDLING FOR EXTENDED STORAGE
10/30234886 DC : 0 BS ISO 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
01/122934 DC : DRAFT AUG 2001 BS EN ISO 14644-5 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS
07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
09/30175345 DC : 0 BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
00/705381 DC : DRAFT FEB 2000 ISO/CD 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL
CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ASTM E 2042/E2042M : 2009 : R2016 Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
ASTM F 2332 : 2006 : R2013 Standard Specification for Annular Ball Bearings for Instruments and Precision Rotating Components
ASTM E 1235 : 2012 : REDLINE Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
I.S. EN ISO 24998:2008 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
ISO 18938:2014 Imaging materials — Optical discs — Care and handling for extended storage
I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments Operations
ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments Test methods
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration
BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
I.S. EN ISO 14644-1:2015 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN ISO 24998:2008 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008)
EN 16602-70-58:2015 Space product assurance - Bioburden control of cleanrooms
EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
MIL-STD-648 Revision E:2016 Specialized Shipping Containers
MIL-STD-750-5 Base Document:2012 HIGH RELIABILITY SPACE APPLICATION TEST METHODS FOR SEMICONDUCTOR DEVICES - PART 5: TEST METHODS 5000 THROUGH 5999
AES 49 : 2005(R2010)
PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
MIL-PRF-38534 Revision K:2017 HYBRID MICROCIRCUITS, GENERAL SPECIFICATION FOR
04/30079743 DC : DRAFT APR 2004 ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ASTM E 1234 : 2012 : REDLINE Standard Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally Controlled Areas for Spacecraft
ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
UNE 171340:2012 Validation and evaluation of controlled environment rooms in hospitals
UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
ASTM F 50 : 2012 Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles
ASTM A 380/A380M : 2017 Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
ASTM E 2352 : 2004 : R2010 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
I.S. EN ISO 15378:2017 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
ONORM EN ISO 14644-3 : 2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
ISO 29701:2010 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test
DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

ISO 31000:2009 Risk management Principles and guidelines
ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces

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