AS/NZS IEC 61223.3.5:2022
Evaluation and routine testing in medical imaging departments Part 3.5: Acceptance and constancy tests — Imaging performance of computed tomography X-ray equipment
Standard AS/NZS IEC 61223.3.5:202X identically adopts IEC 61223 3 5:2019 which defines the essential parameters which describe the performance of CT scanners with regard to image quality, radiation output and patient positioning, define the methods of testing the essential parameters and evaluates conformance to the tolerances of the parameters specified by the accompanying documents. Contains requirements associated with acceptance tests and constancy tests for the CT scanner.
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AS/NZS IEC 61223.3.5:2022 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
English
CONTENTS
FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 General aspects of acceptance tests and constancy tests
4.1 General conditions to be considered in test procedures
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
5.1 Positioning of the patient support
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
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
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
5.4.1 Summary
5.4.2 Test equipment
5.4.3 Test procedure
5.4.4 Data evaluation
5.4.5 Criteria to be applied
5.4.6 Constancy testing
5.5 MEAN CT NUMBER, magnitude of NOISE, and UNIFORMITY
5.5.1 Summary
5.5.2 Test equipment
5.5.3 Test procedure
5.5.4 Scan conditions
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)
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
B.1 Summary
B.2 Methods
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
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
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
Annex€D (informative)Characterization of z-axis spatial resolution
Annex€E (informative)Helical reconstructed section thickness
E.1 Summary
E.2 Test equipment
E.3 Test procedure
E.4 Data evaluation
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
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)
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
G.4.2 Size-dependent modulation evaluation for Paediatric Body protocol elements
G.5 Longitudinal modulation evaluation
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
Annex€H (informative)Mapping of IEC requirements to regulations
Annex€I (informative)Overview of criteria for acceptance and constancy testing for 5.5
Annex€J (informative)Overview of criteria and frequency for all acceptance and constancy testing
Bibliography
Index of defined terms
Figures
Figure 1 – Coordinate system
Figure 2 – Illustration of N x T, R and (N x T) + R
Figure G.1 – test device aligned
Tables
Table 1 – Test pattern for CTDIfree air for Adult Body protocol elements
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
Table H.1 – Mapping of IEC requirements to regulations
Table I.1 – Overview of criteria for acceptance test and constancy test for 5.5
Table J.1 –Overview of criteria and frequency
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AS/NZS IEC 61223.3.5:2022 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
English
CONTENTS
FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 General aspects of acceptance tests and constancy tests
4.1 General conditions to be considered in test procedures
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
5.1 Positioning of the patient support
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
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
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
5.4.1 Summary
5.4.2 Test equipment
5.4.3 Test procedure
5.4.4 Data evaluation
5.4.5 Criteria to be applied
5.4.6 Constancy testing
5.5 MEAN CT NUMBER, magnitude of NOISE, and UNIFORMITY
5.5.1 Summary
5.5.2 Test equipment
5.5.3 Test procedure
5.5.4 Scan conditions
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)
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
B.1 Summary
B.2 Methods
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
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
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
Annex€D (informative)Characterization of z-axis spatial resolution
Annex€E (informative)Helical reconstructed section thickness
E.1 Summary
E.2 Test equipment
E.3 Test procedure
E.4 Data evaluation
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
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)
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
G.4.2 Size-dependent modulation evaluation for Paediatric Body protocol elements
G.5 Longitudinal modulation evaluation
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
Annex€H (informative)Mapping of IEC requirements to regulations
Annex€I (informative)Overview of criteria for acceptance and constancy testing for 5.5
Annex€J (informative)Overview of criteria and frequency for all acceptance and constancy testing
Bibliography
Index of defined terms
Figures
Figure 1 – Coordinate system
Figure 2 – Illustration of N x T, R and (N x T) + R
Figure G.1 – test device aligned
Tables
Table 1 – Test pattern for CTDIfree air for Adult Body protocol elements
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
Table H.1 – Mapping of IEC requirements to regulations
Table I.1 – Overview of criteria for acceptance test and constancy test for 5.5
Table J.1 –Overview of criteria and frequency
Previous versions
AS/NZS IEC 61223.3.5:2022
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.