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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

Available format(s): Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

Superseded date: 31-12-2021

Language(s):

Published date: 20-04-2005

Publisher: International Electrotechnical Committee

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

General Product Information - (Show below) - (Hide below)

Development Note	Also numbered as BS EN 60336. (10/2005) Stability Date: 2017. (09/2017)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Electrotechnical Committee
Status	Superseded
Superseded By	IEC 60336:2020
Supersedes	IEC 60336:1993

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	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

Standards Referenced By This Book - (Show below) - (Hide below)

IEC 60601-2-28 : 3.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
IEC 60601-2-68:2014	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

Standards Referencing This Book - (Show below) - (Hide below)

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
IEC 60601-2-28 : 3.0	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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