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eLibrary > BS EN IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment >

BS EN IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment, 2022

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BS EN IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment, 2022

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Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
Blank Page [Go to Page]
English [Go to Page]
CONTENTS
FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
Figures [Go to Page]
Figure 1 – Coordinate system
Figure 2 – Illustration of N x T, R and (N x T) + R
4 General aspects of acceptance tests and constancy tests [Go to Page]
4.1 General conditions to be considered in test procedures [Go to Page]
4.1.1 General
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
4.2 Documents and data for the tests in the accompanying documents
4.3 Scope of tests
4.4 Considerations for selection of acceptance and constancy tests
4.5 Measuring equipment
4.6 Actions to be taken after a major service action
4.7 Establishment of baseline values
4.8 Frequency of constancy tests
5 Test methods for CT scanners [Go to Page]
5.1 Positioning of the patient support [Go to Page]
5.1.1 Summary
5.1.2 Test equipment
5.1.3 Test procedure
5.1.4 Data evaluation
5.1.5 Criteria to be applied
5.1.6 Constancy testing
5.2 Patient positioning accuracy [Go to Page]
5.2.1 Axial patient positioning accuracy
5.2.2 Sagittal and coronal patient positioning light accuracy (if available)
5.2.3 Constancy testing – Axial, sagittal, and coronal positioning light accuracy
5.3 RECONSTRUCTED SECTION THICKNESS [Go to Page]
5.3.1 General
5.3.2 Reconstructed section thickness for axial scanning
5.3.3 Reconstructed section thickness for helical scanning
5.4 Dose [Go to Page]
5.4.1 Summary
5.4.2 Test equipment
5.4.3 Test procedure
5.4.4 Data evaluation
Tables [Go to Page]
Table 1 – Test pattern for CTDIfree air for Adult Body protocol elements [Go to Page]
5.4.5 Criteria to be applied
5.4.6 Constancy testing
5.5 MEAN CT NUMBER, magnitude of NOISE, and UNIFORMITY [Go to Page]
5.5.1 Summary
5.5.2 Test equipment
5.5.3 Test procedure
5.5.4 Scan conditions
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 [Go to Page]
5.5.5 Criteria to be applied for acceptance test
5.5.6 Criteria to be applied for constancy tests
5.6 Spatial resolution (high contrast) [Go to Page]
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
5.6.5 Data evaluation
5.6.6 Criteria to be applied
5.6.7 Constancy testing
5.7 Automatic exposure control (AEC)
5.8 Low contrast resolution and low contrast detectability
Annex A (informative)Visual method for low contrast resolution
Annex B (informative)Dose profile [Go to Page]
B.1 Summary
B.2 Methods [Go to Page]
B.2.1 Point dosimeter method
B.2.2 Film method
B.2.3 Criteria to be applied
Annex C (informative)Accuracy of the gantry tilt [Go to Page]
C.1 Summary
C.2 Method A [Go to Page]
C.2.1 Test equipment
C.2.2 Test procedure
C.2.3 Data evaluation
C.2.4 Criteria to be applied
C.3 Method B [Go to Page]
C.3.1 Test equipment
C.3.2 Test procedure
C.3.3 Data evaluation
C.4 Criteria to be applied
Annex D (informative)Characterization of z-axis spatial resolution
Annex E (informative)Helical reconstructed section thickness [Go to Page]
E.1 Summary
E.2 Test equipment
E.3 Test procedure
E.4 Data evaluation
Annex F (informative)Guidance on action to be taken [Go to Page]
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
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
Annex G (informative)Automated exposure control (AEC) [Go to Page]
G.1 Overview
G.2 Test equipment
G.3 Test procedure
G.4 Size-dependent modulation evaluation [Go to Page]
G.4.1 Size-dependent modulation evaluation for Adult Body protocol elements
G.4.2 Size-dependent modulation evaluation for Paediatric Body protocol elements
G.5 Longitudinal modulation evaluation
Figure G.1 – test device aligned
G.6 Data evaluation [Go to Page]
G.6.1 Size-dependent modulation evaluation
G.6.2 Longitudinal modulation evaluation
G.7 Criteria to be applied [Go to Page]
G.7.1 Size-dependent modulation evaluation
G.7.2 Longitudinal modulation evaluation
Annex H (informative)Mapping of IEC requirements to regulations [Go to Page]
Table H.1 – Mapping of IEC requirements to regulations
Annex I (informative)Overview of criteria for acceptance and constancy testing for 5.5 [Go to Page]
Table I.1 – Overview of criteria for acceptance test and constancy test for 5.5
Annex J (informative)Overview of criteria and frequency for all acceptance and constancy testing [Go to Page]
Table J.1 –Overview of criteria and frequency
Bibliography
Index of defined terms [Go to Page]

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BS EN IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment, 2022

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