NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management.pdf

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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 29-2013Standard Attributes on CT Equipment Related to Dose Optimization and Management Copyright 2013 by National Electrical Manufacturers Association NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Op

2、timization and Management Published by: National Electrical Manufacturers Association 1300 North 17th Street Rosslyn, Virginia 22209 www.nema.org Copyright 2013 by the National Electrical Manufacturers Association. All rights including translation into other languages, reserved under the Universal C

3、opyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. XR 29-2013 Page ii Copyright 2013 by National Electrical Manufacturers Association NOTICE AND DISCLAIMER The information in this publication was

4、considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document. The National Elec

5、trical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have an interest i

6、n the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information or the soundne

7、ss of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of,

8、application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purpo

9、ses or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or sellers products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf o

10、f any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable ca

11、re in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake to police or e

12、nforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this document shall not be attributable

13、to NEMA and is solely the responsibility of the certifier or maker of the statement. XR 29-2013 Page iii Copyright 2013 by National Electrical Manufacturers Association FOREWORD The first edition of this standard is intended to identify four key features of CT scanners which contribute to or help pe

14、rform optimization and or management of doses of ionizing radiation while still enabling the system to deliver the diagnostic image quality needed by the physician. This standard was developed by the CT Group of the X-Ray Imaging Section of the Medical Imaging & Technology Alliance (MITA), a divisio

15、n of NEMA. Inquiries, comments, and proposed or recommended revisions should be submitted to the X-Ray Imaging section by contacting: Vice President Medical Imaging & Technology Alliance (MITA) 1300 North 17th Street Rosslyn, Virginia 22209 At the time of the approval of the standard, the CT group w

16、as composed of the following members: GE Healthcare Hitachi Medical Systems America, Inc. Neusoft Medical Systems USA, Inc. Neurologica Philips Healthcare Siemens Medical Solutions USA, Inc. Toshiba America Medical Systems At the time of the approval of the standard, the X-Ray Imaging section was co

17、mposed of the following members: Advanced Instrument Development Inc. Agfa HealthCare Aribex, Inc. Bioptics, Inc. Capintec, Inc. CIRS Eizo Nanao Corporation EOS imaging FUJIFILM Medical Systems U.S.A., Inc. GE GE Healthcare Hitachi Medical Systems America, Inc. Hologic Inc. Konica Minolta Medical Im

18、aging USA, Inc. Median Technologies Inc. Medtronic Navigation NeuroLogica Corporation Neusoft Medical Systems, USA, Inc. Philips Healthcare Shimadzu Medical Systems Siemens Healthcare The Phantom Laboratory Toshiba America Medical Systems Inc. Ziehm Imaging, Inc. XR 29-2013 Page iv Copyright 2013 by

19、 National Electrical Manufacturers Association TABLE OF CONTENTS FOREWORDiii Section 1 OVERVIEW1 1.1 SCOPE.1 1.2 RATIONALE.1 1.3 REFERENCES.1 1.3.1 Normative References1 Section 2 DETAILED INFORMATION ON ATTRIBUTES2 2.1 GENERAL.2 2.2 DICOM RADIATION DOSE STRUCTURED REPORTING (RDSR) 2 2.3 DOSE CHECK

20、FEATURE.2 2.4 AUTOMATIC EXPOSURE CONTROL2 2.5 REFERENCE ADULT AND PEDIATRIC PROTOCOLS2 Section 3 IMPLEMENTATION OF STANDARD ATTRIBUTES.3 3.1 MANAGING IMPLEMENTATION.3 XR 29-2013 Page 1 Copyright 2013 by National Electrical Manufacturers Association Section 1 OVERVIEW 1.1 SCOPE This standard identifi

21、es common computed tomography (CT) system (i.e. scanner) attributes that contribute to or help perform optimization/management of doses of ionizing radiation while still enabling the system to deliver the diagnostic image quality needed by the physician. The CT group, MITA and NEMA as a whole convey

22、s its determination and commitment to help ensure that clinicians have the tools needed to manage the amount of radiation that is used. 1.2 RATIONALE This standard is established to assist health care providers to ensure that patients undergoing CT exams undergo procedures that produce images that a

23、re of diagnostic quality while optimizing use of ionizing radiation. The features identified will assist healthcare provides to incorporate up-to-date dose-related features on the devices they utilize in order to maintain the established standard of care established by professional societies and reg

24、ulatory agencies. 1.3 REFERENCES 1.3.1 Normative References By reference herein the following normative documents are adopted, in whole, or in part as indicated in this standards publication. National Electrical Manufacturers Association Medical Imaging Technology Alliance 1300 North 17th Street Arl

25、ington, Virginia 22209 DICOM PS 3.16-2011 Content Mapping Resource DICOM PS 3.3-2011 Information Object Definitions NEMA XR-25-2010 Computed Tomography Dose Check NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT (to be published) International

26、Electrotechnical Commission 3, rue de Varemb Case postale 131 CH-1211 Geneva 20 Switzerland IEC 60601-2-44 Particular requirements for the basic safety and essential Ed. 3 and Ed. 3.1 performance of X-ray equipment for computed tomography XR 29-2013 Page 2 Copyright 2013 by National Electrical Manuf

27、acturers Association Section 2 DETAILED INFORMATION ON ATTRIBUTES 2.1 GENERAL This standard identifies common computed tomography (CT) system (i.e. scanner) attributes that contribute to or help perform optimization and/or management of doses of ionizing radiation while still enabling the system to

28、deliver the diagnostic image quality needed by the physician. These attributes include DICOM Dose Structured Reporting, incorporation of the features and functionality that conform to NEMA XR-25 Computed Tomography Dose Check, various forms of automatic exposure control, and reference pediatric and

29、adult protocols. 2.2 DICOM RADIATION DOSE STRUCTURED REPORTING (RDSR) The CT DICOM structured dose report enables capturing of post exam dose information in a standardized electronic format that can be included in the patient record. It is also the key to being able to monitor and track doses for es

30、tablishment of diagnostic reference levels as well as facility dose management and quality assurance. This information can be found in DICOM PS 3.3-2011 Information Object Definition. 2.3 DOSE CHECK FEATURE The Computed Tomography Dose Check standard provides for features that notify and alert the C

31、T equipment operators, generally technologists, that prepare and set scan parameters (the settings for a particular scan to be administered to a particular patient) prior to a scan. If the estimated dose index is above the value defined and set by the operating group, practice, or organization then

32、a notification is sent to the operator so that person can check the (intended) dose. This attribute is defined in NEMA XR-25 Computed Tomography Dose Check and is additionally defined in IEC 60601-2-44 Ed. 3.1, paragraph 203.107 “Safety measures against excessive X-RADIATION.” 2.4 AUTOMATIC EXPOSURE

33、 CONTROL Automatic exposure control (AEC) is an operational mode that tailors a CT systems radiation output to the specific body regions and parts being imaged in order to manage the radiation delivered to obtain the desired level of diagnostic quality. Reference IEC 60601-2-44 Ed. 3.1, paragraph 20

34、3.106 “Control of RADIATION output” for AEC. Additionally, NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT (to be published) contains a general explanation of AEC functionality that may be present on a CT system. 2.5 REFERENCE ADULT AND PEDIAT

35、RIC PROTOCOLS A protocol is a set of scanning parameters (such as scan type(s): kV, mA, collimation, rotation speed, reconstruction algorithm, etc.) established to accomplish a particular clinical task (such as capturing an image of the abdomen). Protocols pre-loaded on a CT system that may be selec

36、ted at the operators discretion are called reference protocols. Manufacturers develop reference protocols through detailed knowledge of the systems specific performance characteristics and input from clinical collaborators. Protocols may be in the format defined in NEMA XR 28-2013 (to be published).

37、 XR 29-2013 Page 3 Copyright 2013 by National Electrical Manufacturers Association Section 3 IMPLEMENTATION OF STANDARD ATTRIBUTES 3.1 MANAGING IMPLEMENTATION The features identified will assist healthcare provides to incorporate up-to-date, dose-related features on the devices they utilize in order

38、 to maintain the established standard of care established by professional societies and regulatory agencies. Each of the attributes contributes to dose optimization and/or dose management. Even with such attributes on the equipment, clinicians must ensure that operators are trained and knowledgeable

39、 of the functions and operations of these attributes in addition to facilities radiation management policies and procedures. NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION 1300 NORTH 17TH STREET, SUITE 900 ROSSLYN. VA 22209www.NEMA.orgTO ORDER ADDITIONAL NEMA STANDARDS VISITWWW.GLOBAL.IHS.COM OR CALL 1-800-854-7179/1-303-397-79565612_0514TB