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BS EN IEC 61223-3-5:2019

$198.66

Evaluation and routine testing in medical imaging departments – Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment

Published By Publication Date Number of Pages
BSI 2019 68
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PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
10 FOREWORD
12 INTRODUCTION
13 1 Scope and object
14 2 Normative references
3 Terms and definitions
19 Figures
Figure 1 – Coordinate system
21 Figure 2 – Illustration of N x T, R and (N x T) + R
22 4 General aspects of acceptance tests and constancy tests
4.1 General conditions to be considered in test procedures
4.1.1 General
23 4.1.2 Preconditions
4.1.3 BASELINE VALUES
4.1.4 Identification and recording of equipment, instrumentation, and test conditions
4.1.5 TEST DEVICES
24 4.2 Documents and data for the tests in the accompanying documents
25 4.3 Scope of tests
4.4 Considerations for selection of acceptance and constancy tests
26 4.5 Measuring equipment
4.6 Actions to be taken after a major service action
4.7 Establishment of baseline values
27 4.8 Frequency of constancy tests
5 Test methods for CT scanners
5.1 Positioning of the patient support
5.1.1 Summary
5.1.2 Test equipment
5.1.3 Test procedure
28 5.1.4 Data evaluation
5.1.5 Criteria to be applied
5.1.6 Constancy testing
29 5.2 Patient positioning accuracy
5.2.1 Axial patient positioning accuracy
30 5.2.2 Sagittal and coronal patient positioning light accuracy (if available)
5.2.3 Constancy testing – Axial, sagittal, and coronal positioning light accuracy
31 5.3 RECONSTRUCTED SECTION THICKNESS
5.3.1 General
5.3.2 Reconstructed section thickness for axial scanning
33 5.3.3 Reconstructed section thickness for helical scanning
5.4 Dose
5.4.1 Summary
5.4.2 Test equipment
5.4.3 Test procedure
34 5.4.4 Data evaluation
Tables
Table 1 – Test pattern for CTDIfree air for Adult Body protocol elements
35 5.4.5 Criteria to be applied
5.4.6 Constancy testing
36 5.5 MEAN CT NUMBER, magnitude of NOISE, and UNIFORMITY
5.5.1 Summary
37 5.5.2 Test equipment
5.5.3 Test procedure
5.5.4 Scan conditions
38 Table 2 – Combination of protocol elements and phantoms used for acceptance test scans
Table 3 – Combination of protocol elements and phantoms used for constancy test scans
40 5.5.5 Criteria to be applied for acceptance test
41 5.5.6 Criteria to be applied for constancy tests
43 5.6 Spatial resolution (high contrast)
5.6.1 Summary
5.6.2 Information to be supplied in the accompanying documents
5.6.3 Test equipment
5.6.4 Test procedure
44 5.6.5 Data evaluation
5.6.6 Criteria to be applied
5.6.7 Constancy testing
5.7 Automatic exposure control (AEC)
45 5.8 Low contrast resolution and low contrast detectability
46 Annex A (informative)Visual method for low contrast resolution
47 Annex B (informative)Dose profile
B.1 Summary
B.2 Methods
B.2.1 Point dosimeter method
B.2.2 Film method
B.2.3 Criteria to be applied
48 Annex C (informative)Accuracy of the gantry tilt
C.1 Summary
C.2 Method A
C.2.1 Test equipment
C.2.2 Test procedure
C.2.3 Data evaluation
C.2.4 Criteria to be applied
49 C.3 Method B
C.3.1 Test equipment
C.3.2 Test procedure
C.3.3 Data evaluation
C.4 Criteria to be applied
50 Annex D (informative)Characterization of z-axis spatial resolution
51 Annex E (informative)Helical reconstructed section thickness
E.1 Summary
E.2 Test equipment
E.3 Test procedure
E.4 Data evaluation
52 Annex F (informative)Guidance on action to be taken
F.1 Failing the established criteria at first measurement
F.2 Failing the established criteria after repeated measurement
F.3 Marginally failing the established criteria
F.4 Substantially failing the established criteria
53 F.5 History of repeatedly failing the established criteria
F.6 Failing the established constancy criteria but passing the established acceptance criteria
F.7 Cases not covered by Clauses F.1 to F.5
54 Annex G (informative)Automated exposure control (AEC)
G.1 Overview
G.2 Test equipment
G.3 Test procedure
G.4 Size-dependent modulation evaluation
G.4.1 Size-dependent modulation evaluation for Adult Body protocol elements
55 G.4.2 Size-dependent modulation evaluation for Paediatric Body protocol elements
G.5 Longitudinal modulation evaluation
Figure G.1 – test device aligned
56 G.6 Data evaluation
G.6.1 Size-dependent modulation evaluation
G.6.2 Longitudinal modulation evaluation
G.7 Criteria to be applied
G.7.1 Size-dependent modulation evaluation
G.7.2 Longitudinal modulation evaluation
57 Annex H (informative)Mapping of IEC requirements to regulations
Table H.1 – Mapping of IEC requirements to regulations
59 Annex I (informative)Overview of criteria for acceptance and constancy testing for 5.5
Table I.1 – Overview of criteria for acceptance test and constancy test for 5.5
60 Annex J (informative)Overview of criteria and frequency for all acceptance and constancy testing
Table J.1 –Overview of criteria and frequency
64 Bibliography
65 Index of defined terms
BS EN IEC 61223-3-5:2019
$198.66