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IEC 61223-3-4 : 1.0

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IEC 61223-3-4 : 1.0

EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-4: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF DENTAL X-RAY EQUIPMENT

International Electrotechnical Committee

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Table of Contents

FOREWORD<br>INTRODUCTION<br>1 Scope and object<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1 Scope<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2 Object<br>2 Normative references<br>3 Terminology<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 Degree of requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 Use of terms<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3 Defined terms<br>4 General aspects of ACCEPTANCE TESTS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 General conditions to be considered in test <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;procedures<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 Documents and data for the tests<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 Test conditions<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4 Scope of tests<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5 Test equipment including PHANTOMS and TEST <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;DEVICES<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6 Evaluating the test results<br>5 Test methods for dental X-RAY EQUIPMENT with intra-oral<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;X-RAY IMAGE RECEPTOR<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 Visual and functional tests<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2 *X-RAY TUBE VOLTAGE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3 *TOTAL FILTRATION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4 *FOCAL SPOT of the X-RAY TUBE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5 Limitation and alignment of the X-RAY BEAM<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.6 FOCAL SPOT TO SKIN DISTANCE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.7 *Reproducibility of RADIATION OUTPUT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.8 LINE PAIR RESOLUTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.9 LOW CONTRAST RESOLUTION<br>6 Test methods for dental panoramic X-RAY EQUIPMENT with<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;extra-oral X-RAY IMAGE RECEPTOR<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1 Visual and functional tests<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2 X-RAY TUBE VOLTAGE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3 TOTAL FILTRATION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4 FOCAL SPOT of the X-RAY TUBE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5 Limitation and alignment of the X-RAY BEAM<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6 FOCAL SPOT TO SKIN DISTANCE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.7 Reproducibility of RADIATION OUTPUT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.8 LINE PAIR RESOLUTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9 LOW CONTRAST RESOLUTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SCREENS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.11 Image homogeneity<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.12 Indicators for patients' positioning<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.13 Panoramic layer<br>7 Test methods for dental cephalometric X-RAY EQUIPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;with extra-oral X-RAY IMAGE RECEPTOR<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1 Visual and functional tests<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2 X-RAY TUBE VOLTAGE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3 TOTAL FILTRATION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4 FOCAL SPOT of the X-RAY TUBE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5 Limitation and alignment of the X-RAY BEAM<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6 FOCAL SPOT TO SKIN DISTANCE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7 Reproducibility of RADIATION OUTPUT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.8 LINE PAIR RESOLUTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9 LOW CONTRAST RESOLUTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SCREENS<br>8 Test report and statement of compliance<br>Annex A (normative) Terminology - Index of defined terms<br>Annex B (informative) Examples of requirements (accuracy, <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;tolerances, discrepancies according <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;to actual IEC standards or state of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the art)<br>Annex C (informative) ACCEPTANCE TEST for processing of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;non-screen dental X-ray films<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(non-screen film)<br>Bibliography<br>Figure 1 - Dental X-RAY EQUIPMENT with intra-oral X-RAY <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;IMAGE RECEPTOR measuring arrangement for AIR KERMA<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and resolution<br>Figure 2 - Dental X-RAY EQUIPMENT and intra-oral X-RAY IMAGE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;RECEPTOR measuring arrangement for AIR KERMA and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;resolution<br>Figure 3 - Dental Panoramic X-RAY EQUIPMENT with extra-oral<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;X-RAY IMAGE RECEPTOR measuring arrangement for AIR<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;KERMA and resolution<br>Figure 4 - Example of a dental panoramic X-RAY EQUIPMENT with<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;extra-oral digital X-RAY IMAGE RECEPTOR measuring<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;arrangement for AIR KERMA, resolution, image <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;homogeneity and panoramic layer<br>Figure 5 - Example of a cephalometric X-RAY EQUIPMENT with <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;extra-oral X-RAY IMAGE RECEPTOR measuring <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;arrangement for AIR KERMA and resolution<br>Figure 6 - Dental PHANTOM (example)<br>Figure 7 - Dental PHANTOM for digital image acquisition or <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;processing parts (example)<br>Table B.1 - Typical values of FOCAL SPOT dimensions for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;NOMINAL FOCAL SPOT VALUES

Abstract

Applicable to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor. Defines essential parameters that describe the performance of the dental X-ray equipment regarding imaging properties and patient dose; test methods and whether measured quantities that relate to those parameters comply with the specified tolerances.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62