IEC 61223-3-5:2019
Collections
International IEC standards
Publication date
September 2019
Number of pages
126 p.
Reference
IEC 61223-3-5:2019
IEC 61223-3-5:2019
September 2019
International standard
Current
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016.IEC 60601-2-44 and this document? defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3,? defines the methods of testing the essential parameters, and? evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS.The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report.This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER.This document does not apply to? aspects of mechanical and electrical safety, and? aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6:1) modification of the RADIATION protection and control;2) modification of the acceptance testing;3) introduction of constancy testing.The contents of the corrigendum of June 2022 have been included in this copy.
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Sumary
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016.
IEC 60601-2-44 and this document
? defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3,
? defines the methods of testing the essential parameters, and
? evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS.
The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER.
This document does not apply to
? aspects of mechanical and electrical safety, and
? aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.
IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6:
1) modification of the RADIATION protection and control;
2) modification of the acceptance testing;
3) introduction of constancy testing.
The contents of the corrigendum of June 2022 have been included in this copy.
IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016.
IEC 60601-2-44 and this document
? defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3,
? defines the methods of testing the essential parameters, and
? evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS.
The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER.
This document does not apply to
? aspects of mechanical and electrical safety, and
? aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.
IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6:
1) modification of the RADIATION protection and control;
2) modification of the acceptance testing;
3) introduction of constancy testing.
The contents of the corrigendum of June 2022 have been included in this copy.
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Replaced standards
(3)
IEC 61223-3-5:2004
August 2004
International standard
Cancelled
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
This standard - defines the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning; - defines the methods of testing the essential parameters; - evaluates compliance with the tolerances of the parameters specified by the accompanying documents. These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during the installation or after it has been completed. Signed statements covering steps in the installation procedure may be used as part of the acceptance test report. This part of IEC 61223 is intended to assist in performing the acceptance tests on a CT scanner. The aim is to verify compliance of the installation with specifications affecting the image quality, patient dose and positioning. The contents of the corrigendum of March 2006 have been included in this copy.
IEC 61223-3-5:2004/COR1:2006
March 2006
International standard
Cancelled
Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
IEC 61223-2-6:2006
November 2006
International standard
Cancelled
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment
This part of IEC 61223 provides assistance in performing constancy tests on a CT scanner. It applies to those components of CT scanners which influence the image quality, patient dose and positioning. This standard - defines the essential parameters which describe the performance of CT scanners with regard to image quality, patient dose and positioning; the list of parameters to be tested can be found in section 4.5; - defines the methods of testing the essential parameters; - provides criteria to be applied in the evaluation of data for compliance with the tolerances of the parameters specified by the accompanying documents and with respect to baseline values. These methods rely on non-invasive measurements, using appropriate test equipment, performed to ensure that the functional performance of equipment meets established criteria or to enable the early recognition of changes in the properties of components of the equipment. The aim is to verify compliance with specifications affecting the image quality, patient dose and patient positioning.
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