I.S. EN 61223-3-2:2008
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
Hardcopy , PDF
English
01-01-2008
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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