EN ISO 14644-3:2005
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005)
Superseded date
23-10-2019
Superseded by
Published date
15-12-2005
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 General
3.2 Airborne particle measurement
3.3 Air filters and systems
3.4 Airflow and other physical states
3.5 Electrostatic measurement
3.6 Measuring apparatus and measuring conditions
3.7 Occupancy states
4 Test procedures
4.1 Cleanroom tests
4.2 Principle
5 Test reports
Annex A (informative) Choice of recommended tests of an
installation and the sequence in which to carry
them out
Annex B (informative) Test methods
Annex C (informative) Test apparatus
Bibliography
ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.
| Committee |
CEN/TC 243
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN ISO 14644-3:2006 | Identical |
| NEN EN ISO 14644-3 : 2006 | Identical |
| I.S. EN ISO 14644-3:2006 | Identical |
| BS EN ISO 14644-3:2005 | Identical |
| SN EN ISO 14644-3 : 2006 | Identical |
| SS-EN ISO 14644-3 : 2005 | Identical |
| NF EN ISO 14644-3 : 2006 | Identical |
| NS EN ISO 14644-3 : 1ED 2006 | Identical |
| DIN EN ISO 14644-3:2006-03 | Identical |
| PN EN ISO 14644-3 : 2006 | Identical |
| NBN EN ISO 14644-3 : 2006 | Identical |
| UNI EN ISO 14644-3 : 2006 | Identical |
| ISO 14644-3:2005 | Identical |
| ONORM EN ISO 14644-3 : 2006 | Identical |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| BS EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| 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) |
| BS EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) Classification, performance testing, marking |
| DIN EN 1822-1:2011-01 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| 17/30358936 DC : 0 | BS EN 1822-1 - HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| I.S. EN 16442:2015 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| I.S. EN 1822-1:2009 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| VDI 3803 Blatt 4:2012-09 | Air-conditioning, system requirements - Air filter systems (VDI Ventilation Code of Practice) |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| VDI 2083 Blatt 8.1:2014-10 | Cleanroom technology - Air cleanliness chemical concentration (ACC) |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| 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 |
| 12/30248648 DC : DRAFT AUG 2012 | BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES |
| EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| UNI EN 1822-1 : 2010 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| 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 |
| 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) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| PREN 1822-1 : DRAFT 2017 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| 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 |
| UNE-EN 1822-1:2010 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| PD CEN/TS 16244:2018 | Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals |
| ISO 5167-3:2003 | Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 3: Nozzles and Venturi nozzles |
| IEST RP CC007.1 : 1992 | TESTING ULPA FILTERS |
| ASTM F 328 : 1998 | Standard Practice for Calibration of an Airborne Particle Counter Using Monodisperse Spherical Particles |
| ASME N510 : 2007 | TESTING OF NUCLEAR AIR-TREATMENT SYSTEMS |
| 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 RP CC006.3 : 2004 | TESTING CLEANROOMS |
| EN 12599:2012 | Ventilation for buildings - Test procedures and measurement methods to hand over air conditioning and ventilation systems |
| ISO 7726:1998 | Ergonomics of the thermal environment Instruments for measuring physical quantities |
| ISO 5167-4:2003 | Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 4: Venturi tubes |
| SEMI E14 : 1993 | MEASUREMENT OF PARTICLE CONTAMINATION CONTRIBUTED TO THE PRODUCT FROM THE PROCESS OR SUPPORT TOOL |
| EN 1822-2:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics |
| VDI 2083 Blatt 4:1996-02 | Cleanroom technology - Surface cleanliness |
| ISO 5167-2:2003 | Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 2: Orifice plates |
| IEST RP CC021.1 : 1992 | TESTING HEPA AND ULPA FILTER MEDIA |
| IEST G CC1001 : 1999 | COUNTING AIRBORNE PARTICLES FOR CLASSIFICATION AND MONITORING OF CLEANROOMS AND CLEAN ZONES |
| ISO 5167-1:2003 | Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 1: General principles and requirements |
| IEST G CC1003 : 1999 | MEASUREMENT OF AIRBORNE MACROPARTICLES |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| IEST G CC1002 : 1999 | DETERMINATION OF THE CONCENTRATION OF AIRBORNE ULTRAFINE PARTICLES |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| IEST RP CC001.3 : 1993 | HEPA AND ULPA FILTERS |
| IEST RP CC034.2 : 2005 | HEPA AND ULPA FILTER LEAK TESTS |
| EN 1822-4:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method) |
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