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IEC 61223-3-2:2007

Current
Current

The latest, up-to-date edition.

Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French, Spanish, Castilian

Published date

10-07-2007

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General aspects of the ACCEPTANCE TEST
  4.1 Levels of compliance
  4.2 General conditions in test procedures
  4.3 Documents and data for the tests
  4.4 Test conditions
  4.5 Scope of tests
  4.6 Test EQUIPMENT
  4.7 Evaluating the test results
5 Test methods for mammographic X-RAY EQUIPMENT
  5.1 Initial test and inventory
  5.2 X-RAY TUBE VOLTAGE
  5.3 HALF VALUE LAYER (HVL)
  5.4 NOMINAL FOCAL SPOT VALUE
  5.5 X-RAY FIELD limitation and beam alignment
  5.6 Radiation output
  5.7 AUTOMATIC EXPOSURE CONTROL (AEC)
  5.8 Reproducibility of the AIR KERMA
  5.9 ATTENUATION RATIO of material between the upper
       surface of the PATIENT SUPPORT and the IMAGE
       RECEPTION PLANE
  5.10 Breast COMPRESSION DEVICE
  5.11 Uniformity
  5.12 Dynamic range of mammographic X-RAY EQUIPMENT
       using digital X-ray image receptors, including
       storage phosphor systems
  5.13 Spatial resolution
  5.14 LOW CONTRAST DETECTABILITY
  5.15 Entrance surface AIR KERMA
  5.16 Biopsy needle positioning accuracy of MAMMOGRAPHIC
       STEREOTACTIC DEVICES
6 Baseline values for CONSTANCY TESTS
7 Test report and statement of compliance
Annex A (informative) TEST DEVICES and arrangements for
        testing the automatic exposure control system
        with a digital X-RAY IMAGE RECEPTOR
Annex B (informative) TEST DEVICE for testing the dynamic
        range of systems with a digital X-RAY IMAGE RECEPTOR
Annex C (informative) Test methods for screen-film X-ray
        image receptor
Annex D (informative) Test methods for storage phosphor system
Annex E (informative) Example of a method for the determination
        of the AVERAGE GLANDULAR DOSE
Annex F (informative) Example of TEST DEVICES and arrangements
        for testing the system contrast transfer function for
        systems with a digital X-RAY IMAGE RECEPTOR
Annex G (informative) LOW CONTRAST DETECTABILITY test for
        mammographic X-RAY EQUIPMENT using an integrated
        digital X-RAY IMAGE RECEPTOR or storage phosphor
        plates
Annex H (informative) Example of a mammographic
        stereotactic TEST DEVICE
Annex I (normative) Set-up for HALF-VALUE LAYER measurements
Annex J (informative) Definition of the ROIs for testing
        lag effects
Annex K (informative) ARTIFACTS and other non-uniformities
Annex L (informative) Cross reference and history
Bibliography
Terminology - Index of defined terms

This part of IEC 61223 applies to the effectiveness of mammographic X-ray equipment, with respect to image quality and dose, in combination with aspects of equipment safety. This standard applies to mammographic X-ray equipment and mammographic stereotactic devices.The tests described in this standard require the quality and performance of the X-ray image receptors to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-ray equipment. This includes radiographic films, intensifying screens, radiographic cassettes, storage phosphor plates and associated equipment such as film processors or storage phosphor plate readers, image display devices and hard copy cameras.For testing radiographic cassettes and intensifying screens, this standard makes reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are considered to be stated according to ISO 9236-3.By the measurements described in this standard, data for average glandular dose calculation can be determined.When the results of the acceptance test are in compliance with the expected values, the baseline values for the subsequent constancy tests are established.This part of IEC 61223 definesa) the essential parameters which describe the performance of the above-mentioned mammographic X ray equipment with regard to image quality and dose; andb) the methods of testing whether measured quantities related to those parameters comply with specified tolerances.These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the acceptance test. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.

Committee
TC 62/SC 62B
DevelopmentNote
Stability Date: 2022. (09/2017)
DocumentType
Standard
Pages
125
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

BS 5724-2-45(2001) : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
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
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 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
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
13/30267930 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
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
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
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)

ISO 3386-1:1986 Polymeric materials, cellular flexible — Determination of stress-strain characteristics in compression — Part 1: Low-density materials
IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 61674:2012 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 845:2006 Cellular plastics and rubbers — Determination of apparent density
ISO 9236-3:1999 Photography Sensitometry of screen/film systems for medical radiography Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
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
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 4090:2001 Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications
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 TR 60878:2015 Graphical symbols for electrical equipment in medical practice
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 60601-1-3:2008+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 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
IEC 61223-3-3:1996 Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA)
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
IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
IEC 61676:2002+AMD1:2008 CSV Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
IEC 61223-2-4:1994 Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras
EN 573-3:2013 Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products
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 61223-2-5:1994 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices

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