EN 61223-3-2:2008

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
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
Bibliography

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 defines a) the essential parameters which describe the performance of the above-mentioned mammographic X ray equipment with regard to image quality and dose; and b) 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.