ISO 14644-3:2005
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Cleanrooms and associated controlled environments Part 3: Test methods
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
31-08-2019
Superseded by
Language(s)
English, French
Published date
06-12-2005
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| DevelopmentNote |
DRAFT ISO/DIS 14644-3 is also available for this standard. (08/2016)
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| DocumentType |
Standard
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| Pages |
65
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| UNE-EN ISO 14644-3:2006 | Identical |
| ONORM EN ISO 14644-3 : 2006 | Identical |
| GOST R ISO 14644-3 : 2007 ERRATA 2014 | Identical |
| NBN EN ISO 14644-3 : 2006 | Identical |
| NF EN ISO 14644-3 : 2006 | Identical |
| NEN EN ISO 14644-3 : 2006 | Identical |
| NS EN ISO 14644-3 : 1ED 2006 | Identical |
| I.S. EN ISO 14644-3:2006 | Identical |
| PN EN ISO 14644-3 : 2006 | Identical |
| SN EN ISO 14644-3 : 2006 | Identical |
| UNI EN ISO 14644-3 : 2006 | Identical |
| SS-EN ISO 14644-3 : 2005 | Identical |
| BS EN ISO 14644-3:2005 | Identical |
| EN ISO 14644-3:2005 | Identical |
| DIN EN ISO 14644-3:2006-03 | Identical |
| ISO 29463-1:2017 | High efficiency filters and filter media for removing particles from air — Part 1: Classification, performance, testing and marking |
| UNE-EN ISO 16170:2017 | In situ test methods for high efficiency filter systems in industrial facilities (ISO 16170:2016, Corrected version 2017-04) |
| BS EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) Classification, performance testing, marking |
| 09/30182875 DC : 0 | BS ISO 29463-4 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 4: TEST METHOD FOR DETERMINING THE LEAKAGE OF FILTER ELEMENTS (SCAN METHOD) |
| BS EN ISO 24998:2008 | Plastics laboratory ware. Single-use Petri dishes for microbiological procedures |
| I.S. EN ISO 16170:2016 | IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016, CORRECTED VERSION 2017-04) |
| 18/30333968 DC : 0 | BS ISO 8573-4 - COMPRESSED AIR - CONTAMINANT MEASUREMENT - PART 4: PARTICLE CONTENT |
| AAMI ISO 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 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) |
| S.R. CEN ISO TS 27687:2009 | NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE |
| AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| DIN EN ISO 16170:2013-07 (Draft) | IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016) |
| ASTM E 2217 : 2012 : REDLINE | Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas |
| BS EN 1822-2:2009 | High efficiency air filters (EPA, HEPA and ULPA) Aerosol production, measuring equipment, particle counting statistics |
| BS EN ISO 14644-2:2015 | Cleanrooms and associated controlled environments Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| BS EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments Vocabulary |
| BS EN ISO 29462:2013 | Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow |
| BS EN ISO 16890-2:2016 | Air filters for general ventilation Measurement of fractional efficiency and air flow resistance |
| UNE-EN ISO 16890-2:2017 | Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016) |
| 15/30278074 DC : 0 | BS EN ISO 16890-3 - AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| UNE-EN ISO 16890-3:2017 | Air filters for general ventilation - Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured (ISO 16890-3:2016) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| CEN ISO/TS 27687:2009 | Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008, Corrected version 2009-02-01) |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| UNI EN ISO 29461-1 : 2013 | AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS |
| NBR ISO 14644-2 : 2006 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR TESTING AND MONITORING TO PROVE CONTINUED COMPLIANCE WITH ABNT NBR ISO 14644-1 |
| ONORM EN ISO 29462 : 2013 | FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW (ISO 29462:2013) |
| IEC/IEEE 62659:2015 | Nanomanufacturing - Large scale manufacturing for nanoelectronics |
| 12/30248648 DC : DRAFT AUG 2012 | BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES |
| I.S. EN ISO 16890-3:2016 | AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016) |
| I.S. EN ISO 16890-2:2016 | AIR FILTERS FOR GENERAL VENTILATION - PART 2: MEASUREMENT OF FRACTIONAL EFFICIENCY AND AIR FLOW RESISTANCE (ISO 16890-2:2016) |
| PREN ISO 14644-2 : DRAFT 2010 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1 |
| PD CEN ISO/TS 27687:2009 | Nanotechnologies. Terminology and definitions for nano-objects. Nanoparticle, nanofibre and nanoplate |
| 09/30182865 DC : 0 | BS ISO 29463-1 - HIGH EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 1: CLASSIFICATION, PERFORMANCE, TESTING AND MARKING |
| 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) |
| 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) |
| DIN EN 1822-1:2011-01 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| ISO 24998:2008 | Plastics laboratory ware — Single-use Petri dishes for microbiological procedures |
| 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 |
| UNI EN 1822-1 : 2010 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| ISO 29463-3:2011 | High-efficiency filters and filter media for removing particles in air — Part 3: Testing flat sheet filter media |
| EN 1822-2:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics |
| I.S. EN 1822-2:2009 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS |
| I.S. EN 1822-1:2009 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| DIN EN ISO 16890-3:2015-08 (Draft) | AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016) |
| DIN EN ISO 29462:2013-11 | Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013) |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments Part 6: Vocabulary |
| DD ISO/TS 21220:2009 | Particulate air filters for general ventilation. Determination of filtration performance |
| BS EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments Design, construction and start-up |
| BS EN ISO 16890-3:2016 | Air filters for general ventilation Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured |
| UNE-EN ISO 29462:2014 | Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013) |
| I.S. EN ISO 14644-6:2007 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| VDI 3803 Blatt 4:2012-09 | Air-conditioning, system requirements - Air filter systems (VDI Ventilation Code of Practice) |
| DIN EN ISO 16890-3:2017-08 | AIR FILTERS FOR GENERAL VENTILATION - PART 3: DETERMINATION OF THE GRAVIMETRIC EFFICIENCY AND THE AIR FLOW RESISTANCE VERSUS THE MASS OF TEST DUST CAPTURED (ISO 16890-3:2016) |
| 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 |
| DIN EN ISO 16170:2017-05 | IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016) |
| 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 16.1:2010-08 | Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification |
| UNE-EN ISO 14644-14:2017 | Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016) |
| AAMI TIR52 : 2014(R2017) | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| 08/30176845 DC : DRAFT APR 2008 | BS EN 1822-2 - HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTIC |
| DIN EN ISO 16170 E : 2017 | IN SITU TEST METHODS FOR HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES (ISO 16170:2016) |
| 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 |
| 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 |
| ISO 16170:2016 | In situ test methods for high efficiency filter systems in industrial facilities |
| BS ISO 15388:2012 | Space systems. Contamination and cleanliness control |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| BS PD ISO/TR 14969 : 2004 AMD 15958 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| DD CEN ISO/TS 27687 : 2009 | NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE |
| 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 |
| ISO 29463-2:2011 | High-efficiency filters and filter media for removing particles in air — Part 2: Aerosol production, measuring equipment and particle-counting statistics |
| 07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| AAMI TIR52 : 2014 | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| UNE-EN 1822-1:2010 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| AAMI ST15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| I.S. EN 16442:2015 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| ISO 12500-1:2007 | Filters for compressed air Test methods Part 1: Oil aerosols |
| EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| ISO 29463-4:2011 | High-efficiency filters and filter media for removing particles in air — Part 4: Test method for determining leakage of filter elements-Scan method |
| DIN EN 1822-2:2011-01 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS |
| UNE-EN 1822-2:2010 | High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics |
| UNI EN 1822-2 : 2010 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS |
| 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 14644-2:2016-05 | 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) |
| DIN EN ISO 29461-1:2014-03 | Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013) |
| 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 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| DIN EN ISO 16890-2:2017-08 | Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016) |
| I.S. EN ISO 15883-1:2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| 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) |
| I.S. EN ISO 29462:2013 | FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW (ISO 29462:2013) |
| UNI EN ISO 15883-1 : 2014 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| UNI CEN ISO/TS 27687 : 2010 | NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE |
| ISO 29461-1:2013 | Air intake filter systems for rotary machinery Test methods Part 1: Static filter elements |
| UNI EN ISO 29462 : 2013 | FIELD TESTING OF GENERAL VENTILATION FILTRATION DEVICES AND SYSTEMS FOR IN SITU REMOVAL EFFICIENCY BY PARTICLE SIZE AND RESISTANCE TO AIRFLOW |
| 09/30182871 DC : 0 | BS ISO 29463-3 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 3: TEST METHOD FOR FLAT SHEET FILTER MEDIA |
| BS EN ISO 16170:2016 | In situ test methods for high efficiency filter systems in industrial facilities |
| 09/30182868 DC : 0 | BS ISO 29463-2 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT AND PARTICLE-COUNTING STATISTICS |
| 05/30142385 DC : DRAFT NOV 2005 | ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| BS EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| 09/30182882 DC : 0 | BS ISO 29463-5 - HIGH-EFFICIENCY FILTERS AND FILTER MEDIA FOR REMOVING PARTICLES FROM AIR - PART 5: TEST METHOD FOR DETERMINING THE EFFICIENCY OF FILTER ELEMENTS |
| BS ISO 12500-1:2007 | Filters for compressed air. Test methods Oil aerosols |
| DIN EN ISO 24998:2009-03 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| 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) |
| 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 |
| CSA ISO TR 14969 : 2005 : R2015 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| PD CEN ISO/TS 80004-2:2017 | Nanotechnologies. Vocabulary Nano-objects |
| 08/30176838 DC : DRAFT APR 2008 | BS EN 1822-1 - 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 |
| 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 |
| PD CEN/TS 16244:2018 | Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals |
| DIN CEN ISO/TS 27687:2008-11 | NANOTECHNOLOGIES - TERMINOLOGY AND DEFINITIONS FOR NANO-OBJECTS - NANOPARTICLE, NANOFIBRE AND NANOPLATE |
| 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) |
| UNE-EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| I.S. EN ISO 14644-14:2016 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 14: ASSESSMENT OF SUITABILITY FOR USE OF EQUIPMENT BY AIRBORNE PARTICLE CONCENTRATION (ISO/DIS 14644-14) |
| 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 24998:2008 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| ISO 29463-5:2011 | High-efficiency filters and filter media for removing particles in air Part 5: Test method for filter elements |
| 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) |
| UNE-EN ISO 15883-1:2009 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| EN 1822-2 : 2019 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 2: AEROSOL PRODUCTION, MEASURING EQUIPMENT, PARTICLE COUNTING STATISTICS |
| ISO/TS 80004-2:2015 | Nanotechnologies — Vocabulary — Part 2: Nano-objects |
| 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 16890-2:2016 | Air filters for general ventilation — Part 2: Measurement of fractional efficiency and air flow resistance |
| BS EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments Operations |
| ISO 16890-3:2016 | Air filters for general ventilation — Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured |
| 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 |
| 07/30113225 DC : 0 | BS ISO 21220 - PARTICULATE AIR FILTERS FOR GENERAL VENTILATION - DETERMINATION OF THE FILTRATION PERFORMANCE |
| ISO/TS 21220:2009 | Particulate air filters for general ventilation Determination of filtration performance |
| UNE-EN ISO 29461-1:2014 | Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013) |
| UNE-CEN ISO/TS 27687:2010 | Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008) |
| 10/30211683 DC : 0 | BS EN ISO 29461-1 - AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS |
| ISO/TS 27687:2008 | Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate |
| 14/30268894 DC : 0 | BS EN ISO 16890-2 - AIR FILTERS FOR GENERAL VENTILATION - PART 2: MEASUREMENT OF FRACTIONAL EFFICIENCY AND AIR FLOW RESISTANCE |
| 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) |
| BS EN ISO 15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| EN ISO 16890-2:2016 | Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (ISO 16890-2:2016) |
| 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 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| EN ISO 24998:2008 | Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008) |
| EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
| 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 ISO 16890-3:2016 | Air filters for general ventilation - Part 3: Determination of the gravimetric efficiency and the air flow resistance versus the mass of test dust captured (ISO 16890-3:2016) |
| EN ISO 29462:2013 | Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow (ISO 29462:2013) |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| 13/30248319 DC : 0 | BS EN ISO 16170 - IN SITU TEST METHODS FOR VERY HIGH EFFICIENCY FILTER SYSTEMS IN INDUSTRIAL FACILITIES |
| 13/30261893 DC : 0 | BS EN ISO 14644-12 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 12: CLASSIFICATION OF AIR CLEANLINESS BY NANOSCALE PARTICLE CONCENTRATION |
| 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) |
| PREN 1822-1 : DRAFT 2017 | HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| 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 |
| 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 |
| 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 |
| 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) |
| S.R. CEN ISO/TS 80004-2:2017 | NANOTECHNOLOGIES - VOCABULARY - PART 2: NANO-OBJECTS (ISO/TS 80004-2:2015) |
| UNI EN ISO 24998 : 2009 | PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES |
| 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) |
| DIN EN ISO 15883-1:2014-10 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014) |
| EN ISO 29461-1:2013 | Air intake filter systems for rotary machinery - Test methods - Part 1: Static filter elements (ISO 29461-1:2013) |
| BS EN ISO 29461-1:2013 | Air intake filter systems for rotary machinery. Test methods Static filter elements |
| ISO 29462:2013 | Field testing of general ventilation filtration devices and systems for in situ removal efficiency by particle size and resistance to airflow |
| I.S. EN ISO 29461-1:2013 | AIR INTAKE FILTER SYSTEMS FOR ROTARY MACHINERY - TEST METHODS - PART 1: STATIC FILTER ELEMENTS (ISO 29461-1:2013) |
| CEN ISO/TS 80004-2:2017 | Nanotechnologies - Vocabulary - Part 2: Nano-objects (ISO/TS 80004-2:2015) |
| 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 |
| ONORM EN ISO 13408-1 : 2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| 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 |
| 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 |
| ISO 14644-2:2000 | Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 |
| 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 |
| 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) |
| ISO 14644-1:1999 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness |
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