IEC 60336:2005
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
31-12-2021
Superseded by
Published date
20-04-2005
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
FOREWORD
1 Scope
2 Normative references
3 Terms and definitions
4 Determinations for the evaluation of the FOCAL SPOT
characteristics
4.1 Statement of the FOCAL SPOT characteristics
4.2 Longitudinal axis of the X-RAY TUBE ASSEMBLY
4.3 REFERENCE AXIS of the X-RAY TUBE ASSEMBLY
4.4 Direction of evaluation for the FOCAL SPOT length
4.5 Direction of evaluation for the FOCAL SPOT width
5 FOCAL SPOT camera set-up
5.1 Overview
5.2 Test equipment
5.3 Test arrangement
5.4 Total uncertainty of the camera set-up
6 Production of RADIOGRAMS
6.1 Overview
6.2 Operating conditions
6.3 Production of FOCAL SPOT SLIT RADIOGRAMS or FOCAL
SPOT PINHOLE RADIOGRAMS
6.4 Statement of compliance
7 Determination of the LINE SPREAD FUNCTION
7.1 Overview
7.2 Measuring equipment and measuring arrangement
7.3 Measurement of the density distribution
7.4 Determination of the LINE SPREAD FUNCTION
7.5 Statement of compliance
8 Determination of FOCAL SPOT dimensions
8.1 Overview
8.2 Measurement and determination
8.3 Specified NOMINAL FOCAL SPOT VALUES
8.4 Statement of compliance
8.5 Marking of compliance
9 Determination of the MODULATION TRANSFER FUNCTION
9.1 Overview
9.2 Specified MODULATION TRANSFER FUNCTION
9.3 Calculation of the MODULATION TRANSFER FUNCTION
9.4 Evaluation of compliance of the MTF
9.5 Statement of compliance
10 FOCAL SPOT STAR RADIOGRAMS
10.1 Overview
10.2 Test equipment
11 STAR PATTERN RESOLUTION LIMIT
11.1 Overview
11.2 Specified STAR PATTERN RESOLUTION LIMIT
11.3 Measurement
11.4 Determination of the STAR PATTERN RESOLUTION LIMIT
11.5 Evaluation and statement of compliance
12 BLOOMING VALUE
12.1 Overview
12.2 Determination of the BLOOMING VALUE
12.3 Evaluation and statement of compliance
13 Alternate measurement methods
Annex A (informative) Alignment to the REFERENCE AXIS
Annex B (informative) Application of digital X-ray image
detectors for determination of the
FOCAL SPOT characteristics
Annex C (informative) Historical background
Bibliography
Index of defined terms
Applies to focal spots in medical diagnostic X-ray tube assemblies or medical use, operating at X-ray tube voltages up to and including 200 kV. Describes the test methods for evaluating focal spot characteristics and the means for indicating compliance. The contents of the corrigendum of May 2006 have been included in this copy.
| DevelopmentNote |
Also numbered as BS EN 60336. (10/2005) Stability Date: 2017. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
77
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| JIS Z 4120:2008 | Identical |
| NF EN 60336 : 2005 | Identical |
| GOST R IEC 60336 : 2010 | Identical |
| NEN EN IEC 60336 : 2005 C1 2006 | Identical |
| PN EN 60336 : 2005 | Identical |
| BIS IS/IEC 60336 : 2005(R2010) | Identical |
| EN 60336:2005 | Identical |
| OVE/ONORM EN 60336 : 2007 | Identical |
| BS 6530(1994) : 1994 AMD 8835 | Identical |
| UNE 20570:1989 | Identical |
| DIN EN 60336:2006-09 | Identical |
| NEN 10336 : 1995 | Identical |
| BS EN 60335-2-47:1997 | Identical |
| CEI 62-1 : 2ED 1989 | Identical |
| I.S. EN 60336:2005 | Identical |
| UNE-EN 60336:2006 | Identical |
| CEI EN 60336 : 2006 | Identical |
| IEC 60601-2-68:2014 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 13/30247422 DC : 0 | BS EN 62220-1-1 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING |
| BS EN 62220-1-3:2008 | Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency. Detectors used in dynamic imaging |
| CEI EN 60406 : 1998 | CASSETTES FOR MEDICAL X-RAY DIAGNOSIS RADIOGRAPHIC CASSETTES AND MAMMOGRAPHIC CASSETTES |
| 09/30170496 DC : 0 | BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| BS EN 60601-2-44 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009) |
| BS EN 62220-1-2:2007 | Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency. Detectors used in mammography |
| 17/30362279 DC : 0 | BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| BS 6059:1981 | Specification for essential data to be supplied with X-ray tubes and X-ray tube assemblies for medical use |
| 06/30107360 DC : 0 | IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| CEI EN 61262-7 : 1997 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 7: DETERMINATION OF THE MODULATION TRANSFER FUNCTION |
| EN 60406:1997 | Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes |
| BS EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment |
| EN 60601-2-63:2015 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| BIS IS 13450-1-3 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - SECTION 3: COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| CEI EN 62220-1-2 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY |
| NF EN 60601-2-54 : 2009 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| EN 60601-2-65:2013 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
| I.S. EN 61223-2-6:2007 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| EN 61223-3-1:1999 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS |
| EN 60601-2-28:2010 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| NBR IEC 60601-2-65 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| BS EN 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| 07/30161724 DC : 0 | BS IEC 62220-1-3 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-3: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING |
| CSA C22.2 No. 60601-2-28 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| BS EN 60601-2-63:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| BS EN 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments Acceptance tests |
| BS EN 60601-2-65:2013 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| 11/30227728 DC : 0 | BS EN 60601-2-65 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| BS EN 62220-1:2004 | Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency |
| 02/563814 DC : DRAFT SEP 2002 | BS EN 62220-1 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY |
| CEI EN 60601-2-28 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| BS EN 60601-2-28:2010 | Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| CEI EN 62220-1-1 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING |
| I.S. EN 60406:1998 | CASSETTES FOR MEDICAL X-RAY DIAGNOSIS - RADIOGRAPHIC CASSETTES AND MAMMOGRAPHIC CASSETTES |
| NF EN 62220-1-3 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-3: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING |
| I.S. EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| IEC 60406:1997 | Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes |
| I.S. EN 60601-2-65:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV)) |
| IEC 60601-2-28:2017 RLV | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| IEC 60601-2-63:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| I.S. EN 60601-1-3:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
| NEMA XR 5-1992 (R1999) | MEASUREMENT OF DIMENSIONS AND PROPERTIES OF FOCAL SPOTS OF DIAGNOSTIC X-RAY TUBES |
| BS 5724-2.128(1993) : 1993 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR X-RAY SOURCE ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 03/304751 DC : DRAFT APR 2003 | IEC 61223-3-5 ED.1.0 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| BS EN 60406:1997 | Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis |
| BS EN 60601-2-68:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 12/30246621 DC : 0 | BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY BASED IMAGE GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| 15/30329747 DC : 0 | BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| EN 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging |
| BS 4999-146(1988) : 1988 AMD 9192 | GENERAL REQUIREMENTS FOR ROTATING ELECTRICAL MACHINES - DEFINITIONS AND NOMENCLATURE FOR CARBON BRUSHES, BRUSH HOLDERS COMMUTATORS AND SLIP RINGS |
| I.S. EN 60601-2-63:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT |
| I.S. EN 62220-1-3:2008 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-3: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING |
| CSA C22.2 No. 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| NF EN 60601 2-28 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| I.S. EN 61223-3-2:2008 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| IEC 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| IEC 61223-3-2:2007 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| UNE-EN 60601-2-54:2010 | Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 11/30199851 DC : 0 | BS EN 60601-2-63 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| DIN 6868-161:2013-01 | Image quality assurance in diagnostic X-ray departments - Part 161: RoeV acceptance testing of dental radiographic equipment for digital cone-beam computed tomography |
| BS EN 62220-1-1:2015 | Medical electrical equipment. Characteristics of digital x-ray imaging devices Determination of the detective quantum efficiency. Detectors used in radiographic imaging |
| DIN 6823-2:1991-02 | X-RAY TUBE ASSEMBLIES FOR MEDICAL USE; DETERMINATION OF THE DIMENSIONS OF FOCAL SPOTS OF DIAGNOSTIC X-RAY TUBE ASSEMBLIES USING A SLIT CAMERA |
| CSA C22.2 No. 60601-2-28 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| 08/30149952 DC : DRAFT MAY 2008 | BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| CEI EN 62220-1-3 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING |
| 17/30341818 DC : 0 | BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| BS EN 61223-3-1:1999 | Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems |
| CSA C22.2 No. 60601-2-63 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| I.S. EN 60601-2-28:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| I.S. EN 62220-1-1:2015 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING |
| EN 60601-2-68:2015 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| I.S. EN 60601-2-68:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| NF EN 60601 1-3 : 2008 AMD 1 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| I.S. EN 61223-3-5:2004 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| I.S. EN 60601-2-44:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| I.S. EN 62220-1-2:2007 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY |
| IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
| EN 60601-2-44:2009/A2:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016) |
| IEC 60601-2-65:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| IEC 62220-1-3:2008 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| IEC 61223-2-6:2006 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60601-2-45:2011+AMD1:2015 CSV | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| IEC 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| BS EN 60601-1-3 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008) |
| IEC 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
| BS EN 61223-2-6:2007 | Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment |
| IEC 61262-7:1995 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function |
| I.S. EN 60601-2-65:2013/A1:2020 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017) |
| EN 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 04/30124942 DC : DRAFT NOV 2004 | BS EN 61223-2-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 08/30176368 DC : 0 | BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| I.S. EN 62220-1:2004 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY |
| BS EN 60601-2-45 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| I.S. EN 60601-2-45:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| NF EN 60601 2-45 : 2011 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| CEI EN 60601-2-65 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| BS EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| CAN/CSA-C22.2 No. 60601-2-65 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| I.S. EN 61262-7:1997 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 7: DETERMINATION OF THE MODULATION TRANSFER FUNCTION |
| IEC 61223-3-1:1999 | Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems |
| EN 62220-1-3:2008 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| EN 61223-2-6:2007 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| EN 60601-2-45:2011/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015) |
| EN 61262-7:1995 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function |
| EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| EN 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| EN 61223-3-4 : 2000 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-4: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF DENTAL X-RAY EQUIPMENT |
| EN 62220-1:2004 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| EN 60276:1996 | Definitions and nomenclature for carbon brushes, brush-holders, commutators and slip-rings |
| EN 60601-2-54:2009/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| UNE-EN 60601-1-3:2008 | Medical electrical equipment- Part 1-3: General requirements for basic safety and essential performance- Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| IEC 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
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