EN 60336:2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
12-02-2021
07-07-2005
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
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Bibliography
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.
| Committee |
CLC/TC 62
|
| DevelopmentNote |
Supersedes HD 509 (07/2005)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60336:2005 | Identical |
| NEN 10336 : 1995 | Identical |
| I.S. EN 60336:2005 | Identical |
| DIN EN 60336:2006-09 | Identical |
| UNE-EN 60336:2006 | Identical |
| CEI EN 60336 : 2006 | Identical |
| PN EN 60336 : 2005 | Identical |
| SN EN 60336 : 1995 | Identical |
| BS EN 60336:2005 | Identical |
| NBN EN 60336 : 2006 | Identical |
| NF EN 60336 : 2005 | Identical |
| NEN EN IEC 60336 : 2005 C1 2006 | Identical |
| OVE/ONORM EN 60336 : 2007 | Identical |
| 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 |
| 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 |
| BS EN 50631-1:2017 | Household appliances network and grid connectivity General Requirements, Generic Data Modelling and Neutral Messages |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 60601-2-65:2013 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| 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 |
| BS EN 62220-1:2004 | 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 |
| 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)) |
| 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) |
| 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 60406:1997 | Specification for radiographic cassettes and mammographic cassettes used for medical X-ray 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 50631-1:2017 | HOUSEHOLD APPLIANCES NETWORK AND GRID CONNECTIVITY - PART 1: GENERAL REQUIREMENTS, GENERIC DATA MODELLING AND NEUTRAL MESSAGES |
| EN 50631-1:2017 | Household appliances network and grid connectivity - Part 1: General Requirements, Generic Data Modelling and Neutral Messages |
| 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 |
| 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) |
| 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) |
| 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 |
| 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 |
| I.S. EN 62220-1:2004 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY |
| 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 |
| 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 |
| 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 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 62220-1:2004 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| 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 |
| EN 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| 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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