IEC 62464-1:2018 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for \u2013 quality assessment in the ACCEPTANCE TEST, and \u2013 quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address \u2013 image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated, \u2013 image quality affected by MR-compatibility issues, \u2013 special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and \u2013 TYPE TESTS. The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images. The measurement procedures specified in this document are directed to \u2013 MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document, \u2013 test houses, who can confirm performance of MR EQUIPMENT using methods described in this document, \u2013 regulatory authorities, who can reference this document, and \u2013 RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document. The essential image quality parameters and measurement methodologies defined in this document are \u2013 SIGNAL TO NOISE RATIO, \u2013 UNIFORMITY, \u2013 SLICE THICKNESS in 2-D scanning, \u2013 2-D GEOMETRIC DISTORTION, \u2013 SPATIAL RESOLUTION, and \u2013 GHOSTING ARTEFACTS. Each of these procedures can be performed standalone or in combination with any of the other procedures. This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these alternative normative methods. If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT. IEC 62464-1:2018 cancels and replaces the first edition published in 2007. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the tests have been revised to comply with the technical progress; b) the range of B0 was increased from 4 T to 8 T.<\/p>\n
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| 130<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 133<\/td>\n | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 135<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 139<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 141<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 143<\/td>\n | 1 Scope <\/td>\n<\/tr>\n | ||||||
| 144<\/td>\n | 2 Normative references 3 Terms, definitions, symbols and abbreviated terms 3.1 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 149<\/td>\n | 4 * Procedures for the determination of essential image parameters 4.1 General requirements for all procedures 4.1.1 Requirements for the system 4.1.2 Requirements for the test device 4.1.3 Scan parameters <\/td>\n<\/tr>\n | ||||||
| 150<\/td>\n | 4.1.4 Reporting of results <\/td>\n<\/tr>\n | ||||||
| 151<\/td>\n | Tables Table 1 \u2013 Common parameters <\/td>\n<\/tr>\n | ||||||
| 152<\/td>\n | Table 2 \u2013 Acquisition parameters <\/td>\n<\/tr>\n | ||||||
| 153<\/td>\n | 4.2 * Signal to noise ratio 4.2.1 Objectives and rationale 4.2.2 Requirements for the test device 4.2.3 Scan parameters 4.2.4 Measurement procedure <\/td>\n<\/tr>\n | ||||||
| 154<\/td>\n | 4.2.5 Data analysis and tolerances 4.2.6 Reporting of results <\/td>\n<\/tr>\n | ||||||
| 155<\/td>\n | 4.3 * Uniformity 4.3.1 Objectives and rationale 4.3.2 Requirements for the test device 4.3.3 Scan parameters Table 3 \u2013 Reporting of results for SNR <\/td>\n<\/tr>\n | ||||||
| 156<\/td>\n | 4.3.4 Measurement procedure 4.3.5 Data analysis and tolerances 4.3.6 Reporting of results Table 4 \u2013 Reporting of results for uniformity <\/td>\n<\/tr>\n | ||||||
| 157<\/td>\n | 4.4 Slice thickness in 2-D scanning 4.4.1 Objectives and rationale 4.4.2 Requirements for the test device <\/td>\n<\/tr>\n | ||||||
| 158<\/td>\n | 4.4.3 Scan parameters Figures Figure 1 \u2013 Signal intensity profile in the inclined slab method <\/td>\n<\/tr>\n | ||||||
| 159<\/td>\n | 4.4.4 Measurement procedure 4.4.5 Data analysis and tolerances <\/td>\n<\/tr>\n | ||||||
| 160<\/td>\n | 4.4.6 Reporting of results 4.4.7 Reporting of acceptance results 4.5 * Two-dimensional geometric distortion 4.5.1 Objectives and rationale Figure 2 \u2013 Correcting for rotation of test device Table 5 \u2013 Reporting of results for slice thickness <\/td>\n<\/tr>\n | ||||||
| 161<\/td>\n | 4.5.2 * Requirements for the test device <\/td>\n<\/tr>\n | ||||||
| 162<\/td>\n | Figure 3 \u2013 Example of a boundary wall test device for a spherical specification volume with two lines passing through the centre <\/td>\n<\/tr>\n | ||||||
| 163<\/td>\n | 4.5.3 Scan parameters 4.5.4 * Measurement procedure Figure 4 \u2013 Example of a fiducial marker test device for a spherical specification volume <\/td>\n<\/tr>\n | ||||||
| 164<\/td>\n | 4.5.5 * Data analysis and tolerances Figure 5 \u2013 Distances to be determined <\/td>\n<\/tr>\n | ||||||
| 165<\/td>\n | 4.5.6 Reporting of results 4.6 * Spatial resolution 4.6.1 Objectives and rationale 4.6.2 Requirements for the test device Table 6 \u2013 Reporting of results for geometric distortion <\/td>\n<\/tr>\n | ||||||
| 166<\/td>\n | 4.6.3 Scan parameters Figure 6 \u2013 Periodic pattern <\/td>\n<\/tr>\n | ||||||
| 167<\/td>\n | 4.6.4 Measurement procedure Figure 7 \u2013 Image of periodic pattern and position of roi for coronal scans Table 7 \u2013 Phantom, plane and gradient orientation for resolution assessment <\/td>\n<\/tr>\n | ||||||
| 168<\/td>\n | 4.6.5 Data analysis and tolerances 4.6.6 Reporting of results Figure 8 \u2013 Image of periodic pattern and position of roifor transverse and sagittal scans <\/td>\n<\/tr>\n | ||||||
| 169<\/td>\n | 4.6.7 Reporting of acceptance results 4.7 * Ghosting artefacts 4.7.1 Objectives and rationale 4.7.2 * Requirements for the test device 4.7.3 Scan parameters Table 8 \u2013 Reporting of results for spatial resolution <\/td>\n<\/tr>\n | ||||||
| 170<\/td>\n | 4.7.4 Measurement procedure 4.7.5 Data analysis and tolerances <\/td>\n<\/tr>\n | ||||||
| 171<\/td>\n | 4.7.6 Reporting of results Figure 9 \u2013 Example image of the test device and regionof interest (roi) for signal, ghost, and noise measurements Table 9 \u2013 Reporting of results for ghosting artefacts <\/td>\n<\/tr>\n | ||||||
| 172<\/td>\n | 5 * Constancy test 5.1 Objectives and rationale 5.2 Requirements for the test device 5.3 Scan characteristics 5.4 Measurement procedure <\/td>\n<\/tr>\n | ||||||
| 173<\/td>\n | 5.5 Data analysis, reporting of results and tolerances Table 10 \u2013 Required constancy tests \u2013 Parameter settings <\/td>\n<\/tr>\n | ||||||
| 174<\/td>\n | Annex A (normative)Alternative methods A.1 Pertaining to 4.2 signal to noise ratio A.1.1 General A.1.2 Alternative method: snr measurements using alternative noise determination <\/td>\n<\/tr>\n | ||||||
| 175<\/td>\n | A.1.3 Alternative method: snr “single image” <\/td>\n<\/tr>\n | ||||||
| 176<\/td>\n | A.2 Pertaining to 4.3 Uniformity A.2.1 General A.2.2 Alternative method “grey-scale map” <\/td>\n<\/tr>\n | ||||||
| 177<\/td>\n | Table A.1 \u2013 Reporting of results for uniformity “grey-scale map” <\/td>\n<\/tr>\n | ||||||
| 178<\/td>\n | A.2.3 Alternative method “ACR method” A.3 Pertaining to 4.4\u2003Slice thickness in 2-D scanning A.3.1 General <\/td>\n<\/tr>\n | ||||||
| 179<\/td>\n | A.3.2 Alternative method: slice thickness in 2-D scanning: wedge method Figure A.1 \u2013 Wedge test device <\/td>\n<\/tr>\n | ||||||
| 180<\/td>\n | Figure A.2 \u2013 Measurement of slice profile and slice thickness using wedge test device <\/td>\n<\/tr>\n | ||||||
| 181<\/td>\n | A.4 Pertaining to 4.5 Two-dimensional geometric distortion A.4.1 General A.4.2 Alternative method: geometric distortion measurements using elliptical boundary test devices <\/td>\n<\/tr>\n | ||||||
| 182<\/td>\n | A.4.3 Alternative method: 3D geometric distortion component measurement method Figure A.3 \u2013 Determination of radius length of an ellipse with semi axis lengtha and b forming an angle \u03b1 with respect to the X axis <\/td>\n<\/tr>\n | ||||||
| 184<\/td>\n | Figure A.4 \u2013 Possible test device configurations for measuring geometric distortion <\/td>\n<\/tr>\n | ||||||
| 185<\/td>\n | Table A.2 \u2013 Recommended fiducial volumes <\/td>\n<\/tr>\n | ||||||
| 186<\/td>\n | Figure A.5 \u2013 Two elements with an apparent spacing of Ai(x,y) buta true spacing of Ti(x,y) <\/td>\n<\/tr>\n | ||||||
| 188<\/td>\n | Figure A.6 \u2013 A schematic of a spatial mapping geometric distortion plot <\/td>\n<\/tr>\n | ||||||
| 189<\/td>\n | A.5 Pertaining to 4.6 spatial resolution A.5.1 General Figure A.7 \u2013 Scatter plot of geometric distortion error Table A.3 \u2013 Example of error table <\/td>\n<\/tr>\n | ||||||
| 190<\/td>\n | A.5.2 Alternative method: determination of the full modulation transfer function <\/td>\n<\/tr>\n | ||||||
| 191<\/td>\n | A.6 Pertaining to 5 Constancy tests A.6.1 Alternative constancy test methods Table A.4 \u2013 Reporting of results for spatial resolution (MTF method) <\/td>\n<\/tr>\n | ||||||
| 192<\/td>\n | Table A.5 \u2013 Reporting of results for centre frequency <\/td>\n<\/tr>\n | ||||||
| 193<\/td>\n | Table A.6 \u2013 Reporting of results for RF calibration <\/td>\n<\/tr>\n | ||||||
| 194<\/td>\n | A.6.2 Pitfalls Table A.7 \u2013 Reporting of results for geometric accuracy <\/td>\n<\/tr>\n | ||||||
| 195<\/td>\n | Annex B (informative)Rationale B.1 Pertaining to 4 * Procedures for the determination of essential image parameters B.2 Pertaining to 4.2 Signal to noise ratio B.2.1 Rationale <\/td>\n<\/tr>\n | ||||||
| 197<\/td>\n | Figure B.1 \u2013 Relaxation times T1 and T2 in dependencyon the concentration of CuSO4 x 5 H2O <\/td>\n<\/tr>\n | ||||||
| 198<\/td>\n | Table B.1 \u2013 Test device conductivity and dielectric properties <\/td>\n<\/tr>\n | ||||||
| 200<\/td>\n | Table B.2 \u2013 Bandwidth-related quantities as provided by different vendors <\/td>\n<\/tr>\n | ||||||
| 201<\/td>\n | Table B.3 \u2013 Relaxation fit parameters for Gd(TMHD) at concentrations \u2264 4 parts per thousand by weight <\/td>\n<\/tr>\n | ||||||
| 202<\/td>\n | Table B.4 \u2013 Noise correction factors by number of complex channels <\/td>\n<\/tr>\n | ||||||
| 208<\/td>\n | B.2.2 References B.3 Pertaining to 4.3 Uniformity B.3.1 Rationale B.3.2 AAD method B.3.3 Standing waves <\/td>\n<\/tr>\n | ||||||
| 209<\/td>\n | B.4 Pertaining to 4.5 Two-dimensional geometric distortion B.4.1 Rationale <\/td>\n<\/tr>\n | ||||||
| 210<\/td>\n | B.4.2 Pitfalls <\/td>\n<\/tr>\n | ||||||
| 211<\/td>\n | Figure B.2 \u2013 Centring error <\/td>\n<\/tr>\n | ||||||
| 214<\/td>\n | B.5 Pertaining to 4.6 Spatial resolution B.5.1 Rationale <\/td>\n<\/tr>\n | ||||||
| 215<\/td>\n | B.5.2 Pitfalls <\/td>\n<\/tr>\n | ||||||
| 216<\/td>\n | B.6 Pertaining to 4.7 Ghosting artefacts B.6.1 Rationale B.6.2 Pitfalls <\/td>\n<\/tr>\n | ||||||
| 217<\/td>\n | B.6.3 References B.7 Pertaining to 5 Constancy test \u2013 Rationale <\/td>\n<\/tr>\n | ||||||
| 219<\/td>\n | Index of defined terms <\/td>\n<\/tr>\n | ||||||
| 220<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Magnetic resonance equipment for medical imaging – Determination of essential image quality parameters<\/b><\/p>\n |