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

Status : Current   Published : November 2019

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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


â?¢ 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,


â?¢ defines the methods of testing the essential parameters, and


â?¢ 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


â?¢ aspects of mechanical and electrical safety, and


â?¢ 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.




Standard NumberBS EN IEC 61223-3-5:2019
TitleEvaluation and routine testing in medical imaging departments. Acceptance tests and and constancy tests. Imaging performance of computed tomography X-ray equipment
StatusCurrent
Publication Date14 November 2019
Normative References(Required to achieve compliance to this standard)IEC/TR 60788:2004, EN 60601-1:2006, EN 60601-2-44:2009/A2:2016, IEC 60601-2-44:2009/AMD1:2012, IEC 60601-1:2005, IEC TR 60788:2004, EN 60601-1:2006/A12:2014, EN 60601-2-44:2009/A11:2011, IEC 60601-1:2005/AMD1:2012, IEC 60601-2-44:2009, EN 60601-1:2006/A1:2013, EN 60601-2-44:2009/A1:2012, EN 60601-2-44:2009, IEC 60601-2-44:2009/AMD2:2016
Informative References(Provided for Information)IEC 61674:2012
ReplacesBS EN 61223-3-5:2004
International RelationshipsEN IEC 61223-3-5:2019,IEC 61223-3-5:2019
Draft Superseded By18/30363098 DC
DescriptorsQuality control, Electrical medical equipment, Photographic images, Diagnosis (medical), Radiography, Radiation measurement, Performance, Computed tomography, Approval testing, Image processing (computer), Acceptance (approval), Medical radiography, Medical radiology, Data representation, Quality, Performance testing, Tomography, X-ray apparatus, Conformity, Radiology apparatus (medical)
ICS11.040.50
Title in FrenchEssais d'évaluation et de routine dans les services d'imagerie médicale Essais d'acceptation et de constance. Performance d'imagerie des équipements de tomodensitométrie à rayonnement X
Title in GermanBewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung Abnahmeprüfungen. Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen für Computertomographie
CommitteeCH/62/2
ISBN978 0 580 99133 2
PublisherBSI
FormatA4
DeliveryYes
Pages68
File Size1.493 MB
Price£254.00


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