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
Publisher
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 |
| Standards | Relationship |
| DIN EN ISO 14644-1:2016-06 | Identical |
| BS EN ISO 14644-1:2015 | Identical |
| NBN EN ISO 14644-1 : 2016 | Identical |
| NEN EN ISO 14644-1 : 2016 | Identical |
| UNE-EN ISO 14644-1:2016 | Identical |
| SN EN ISO 14644-1 : 2016 | Identical |
| SS-EN ISO 14644-1 : 2016 | Identical |
| UNI EN ISO 14644-1 : 2016 | Identical |
| ISO 14644-1:2015 | Identical |
| NS EN ISO 14644-1 : 1999 | Identical |
| I.S. EN ISO 14644-1:2015 | Identical |
| UNI EN ISO 14644-1 : 2001 | Identical |
| NF EN ISO 14644-1 : 1999 | Identical |
| PN EN ISO 14644-1 : 2016 | Identical |
| NF EN ISO 14644-1 : 2016 | Identical |
| 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 |
| DIN EN 16442 E : 2015 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| 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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