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EN 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 (ISO 14644-1:2015)

Published date

23-12-2015

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European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Demonstration of compliance
Annex A (normative) - Reference method for classification
        of air cleanliness by particle concentration
Annex B (informative) - Examples of classification
        calculations
Annex C (informative) - Counting and sizing of airborne
        macroparticles
Annex D (informative) - Sequential sampling procedure
Annex E (informative) - Specification of intermediate decimal
        cleanliness classes and particle size thresholds
Annex F (informative) - Test instruments
Bibliography

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 14644‑7.Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm 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 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) 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 µm).ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

Committee
CEN/TC 243
DevelopmentNote
Supersedes PREN ISO 14644-1. (01/2016)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
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)
I.S. EN 62258-1:2010 SEMICONDUCTOR DIE PRODUCTS - PART 1: PROCUREMENT AND USE
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
CLC/TR 62258-3:2007 Semiconductor die products - Part 3: Recommendations for good practice in handling, packing and storage
EN 62258-1:2010 Semiconductor die products - Part 1: Procurement and use
BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
PD CLC/TR 62258-3:2007 Semiconductor die products Recommendations for good practice in handling, packing and storage
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
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)
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
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)
BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments Design, construction and start-up
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
VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
VDI 4066 Blatt 1:2013-05 Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria
VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
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/VDE 2627 Blatt 1:2015-12 Measuring rooms - Classification and characteristics - Planning and execution
VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
VDI 2083 Blatt 13.1:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
VDI 3455:2013-08 Emission control - High-volume car body painting plants
VDI/VDE 3516 Blatt 2:1981-07 Process analytical equipment for fluids
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 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
I.S. CLC/TR 62258-3:2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
09/30176561 DC : 0 BS EN ISO 5667 - WATER QUALITY - SAMPLING - PART 23: DETERMINATION OF PRIORITY POLLUTANTS IN SURFACE WATER USING PASSIVE SAMPLING
UNE-EN 16372:2015 Aesthetic surgery services
12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
BS EN ISO 11551:2003 Optics and optical instruments. Lasers and laser-related equipment. Test method for absorptance of optical laser components
I.S. EN 14777:2004 SPACE ENGINEERING - MULTIPACTION DESIGN AND TEST
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 EN 62258-1:2010 Semiconductor die products Procurement and use
DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
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
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 11551:2003 Optics and optical instruments Lasers and laser-related equipment Test method for absorptance of optical laser components
ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
BS EN 131-2 : 2010 LADDERS - PART 2: REQUIREMENTS, TESTING, MARKING
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
EN 14777:2004 Space engineering - Multipaction design and test
EN 16372:2014 Aesthetic surgery services
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 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
BS EN 16372:2014 Aesthetic surgery services
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)
17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
CEN/TS 16244:2018 Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
CEI CLC/TR 62258-3 : 2007 SEMICONDUCTOR DIE PRODUCTS - PART 3: RECOMMENDATIONS FOR GOOD PRACTICE IN HANDLING, PACKING AND STORAGE
PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
BS EN 14777:2004 Space engineering. Multipaction design and test
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 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
EN 131-2:2010+A2:2017 Ladders - Part 2: Requirements, testing, marking

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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