BS EN IEC 61223-3-6:2020
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Evaluation and routine testing in medical imaging departments – Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 60 |
IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose. Excluded from the scope of this document are: – MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS; – 2D images synthesised from the tomosynthesis images; – reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS; – CT SCANNERS covered by IEC 61223-3-5. IEC 61223-3-6:2020 defines a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose, b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and c) CONSTANCY TEST frequency when required. This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation. 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. When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
| 7 | English CONTENTS |
| 11 | FOREWORD |
| 13 | INTRODUCTION |
| 14 | 1 Scope and object 2 Normative references |
| 15 | 3 Terms, definitions, symbols and abbreviated terms 3.1 Terms and definitions |
| 18 | 3.2 Symbols and abbreviated terms 4 General aspects of the acceptance test 4.1 Levels of requirements 4.1.1 Local regulatory 4.1.2 Contractual 4.1.3 General 4.2 General conditions in test procedures |
| 19 | 4.3 Documents and data for the tests 4.4 Test conditions |
| 20 | 4.5 Scope of tests 4.6 Test equipment 4.6.1 General |
| 21 | 4.6.2 Analysis software 4.6.3 Dosimeter 4.7 Evaluating the test results |
| 22 | 5 General aspects of constancy tests 5.1 Establishment of baseline values 5.2 Frequency of constancy tests 6 Summary of tests for mammographic tomosynthesis equipment Tables Table 1 – Tests, test frequencies, and test objects used in this document |
| 23 | 7 Inventory and initial tests for mammographic tomosynthesis equipment 7.1 Requirements |
| 24 | 7.2 Test method 7.3 Constancy testing 7.3.1 Test method 7.3.2 Frequency of testing 7.4 Action to be taken 8 Alignment and collimation checks 8.1 Requirements 8.2 Test method |
| 25 | 8.3 Constancy testing 8.3.1 Test method 8.3.2 Frequency of testing 8.4 Equipment 8.5 Action to be taken 9 AEC-system 9.1 General Figures Figure 1 – Set-up for measuring the alignment between the reconstructed and the irradiated volume at the chest wall edge of the patient support |
| 26 | 9.2 Short term reproducibility 9.2.1 Requirements 9.2.2 Test method 9.2.3 Constancy testing 9.2.4 Equipment 9.2.5 Action to be taken 9.3 Long term reproducibility 9.3.1 Requirements |
| 27 | 9.3.2 Test method 9.3.3 Constancy testing 9.3.4 Action to be taken 9.4 AEC performance 9.4.1 Requirements 9.4.2 Test method |
| 28 | Figure 2 – Top and 3D view of setup for the AEC performance measurements |
| 29 | Figure 3 – Placement of ROI for the AEC performance measurement Table 2 – Height of the compression paddle when using different PMMA thicknesses |
| 30 | 9.4.3 Constancy testing 9.4.4 Equipment 9.4.5 Action to be taken 10 Image receptor 10.1 Response function 10.1.1 General |
| 31 | 10.1.2 Requirements 10.1.3 Test method 10.1.4 Constancy testing 10.1.5 Action to be taken |
| 32 | 10.2 Detector element failure 10.2.1 Requirements 10.2.2 Test method 10.2.3 Constancy testing 10.2.4 Equipment 10.2.5 Action to be taken 10.3 Uncorrected defective detector elements 10.3.1 General 10.3.2 Requirements 10.3.3 Test method |
| 33 | 10.3.4 Constancy testing 10.3.5 Equipment 10.3.6 Action to be taken 10.4 System projection MTF 10.4.1 General 10.4.2 Requirements |
| 34 | 10.4.3 Test method 10.4.4 Constancy testing 10.4.5 Equipment 10.4.6 Action to be taken 11 Image quality of the reconstructed image 11.1 Phantom testing 11.1.1 General 11.1.2 Requirements |
| 35 | 11.1.3 Test method 11.1.4 Constancy testing 11.1.5 Action to be taken 11.2 z-resolution (artefact spread function) 11.2.1 Requirements 11.2.2 Test method |
| 36 | Figure 4 – Top and 3D view of setup for the evaluation of z-resolution |
| 37 | 11.2.3 Constancy testing 11.2.4 Equipment 11.2.5 Action to be taken 12 Missed tissue 12.1 General Figure 5 – Front and side view of setup for the evaluation of z-resolution |
| 38 | 12.2 Missed tissue at chest wall side in the reconstructed tomosynthesis volume 12.2.1 Requirements 12.2.2 Test method 12.2.3 Constancy testing 12.2.4 Equipment 12.2.5 Action to be taken 12.3 Missed tissue at the top and bottom of the reconstructed tomosynthesis volume 12.3.1 Requirements 12.3.2 Test method |
| 39 | 12.3.3 Constancy testing Figure 6 – Configuration for the determination of missed tissue for curved paddles |
| 40 | 12.3.4 Equipment 12.3.5 Action to be taken 13 Artefacts in the tomosynthesis data sets 13.1 General 13.2 Artefact evaluation 13.2.1 Requirements 13.2.2 Test method 13.2.3 Constancy testing 13.2.4 Equipment 13.2.5 Action to be taken 13.3 Geometric distortion 13.3.1 Requirements |
| 41 | 13.3.2 Test method Figure 7 – Top and 3D view of setup for the evaluation of geometric distortion |
| 42 | 13.3.3 Equipment 13.3.4 Action to be taken 14 Dosimetry for digital breast tomosynthesis 14.1 Requirements Figure 8 – Front and side view of setup for the evaluation of geometric distortion |
| 43 | 14.2 Test method Table 3 – Limits for AGD versus the thickness of the PMMA and the height of the compression paddle |
| 44 | 14.3 Constancy testing 14.3.1 Test method 14.3.2 Frequency of testing 14.4 Equipment 14.5 Action to be taken Figure 9 –Top and 3D view of position of dosimeter to determine the incident air kerma for dose estimation |
| 45 | Annex A (informative)Tables for dosimetry calculation in digital breast tomosynthesis Table A.1 – g factors for breasts simulated with PMMA Table A.2 – c factors for breasts simulated with PMMA |
| 46 | Table A.3 – Typical HVL measurements for different tube voltage and target filter combinations Table A.4 – s factors for clinically used spectra Table A.5 – s factors for clinically used spectra with W target material |
| 47 | Table A.6 – s factors for a tungsten target filtered by 0,5 mm aluminium Table A.7 – s factors for a tungsten target filtered by 0,7 mm aluminium |
| 48 | Table A.8 – T factors vs. PMMA thickness for a variety of scan angles |
| 49 | Annex B (normative)Guidance on action to be taken |
| 51 | Annex C (informative)Image quality evaluation |
| 52 | Annex D (informative)Artefacts |
| 53 | Bibliography |
| 57 | Index of defined terms |
