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IEC 61223-3-4:2000

Current
Current

The latest, up-to-date edition.

Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
Available format(s)

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

Language(s)

English, Spanish, Castilian

Published date

21-03-2000

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

Applies 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 (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.

Committee
TC 62/SC 62B
DevelopmentNote
Also numbered as BS EN 61223-3.4. (01/2006) Stability Date: 2018. (09/2017)
DocumentType
Standard
Pages
35
PublisherName
International Electrotechnical Committee
Status
Current

BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
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
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
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 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
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
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 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
ISO 2092:1981 Light metals and their alloys Code of designation based on chemical symbols
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 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics

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