NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT.pdf
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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 28-2013Supplemental Requirements for User Information and SystemFunction Related to Dosein CTNEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT Published by: National
2、Electrical Manufacturers Association 1300 North 17th Street, Suite 900 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 Copyright Convention, the Berne Convent
3、ion for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. XR 28-2013 Page ii 2013 National Electrical Manufacturers Association NOTICE AND DISCLAIMER The information in this publication was considered technically sound by the consensus of pe
4、rsons 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 Electrical Manufacturers Association (NEMA) standards a
5、nd 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 in the topic covered by this publication. While NEMA
6、 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 soundness of any judgments contained in its standards and
7、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, application, or reliance on this document. NEMA dis
8、claims 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 purposes or needs. NEMA does not undertake to guarantee
9、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 of any person or entity, nor is NEMA undertaking to
10、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 care in any given circumstances. Information and othe
11、r 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 enforce compliance with the contents of this documen
12、t. 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 to NEMA and is solely the responsibility of the cer
13、tifier or maker of the statement. XR 28-2013 Page iii 2013 National Electrical Manufacturers Association Table of Contents NOTICE AND DISCLAIMER . ii FOREWORD . iv Section 1 - OVERVIEW .1 1.1 SCOPE .1 1.2 RATIONALE .1 1.3 REFERENCES 1 1.3.1 Normative References1 Section 2 - Additional User Informati
14、on 3 2.1 General .3 2.2 Perfusion Scanning3 2.3 Automatic Exposure Control vs. Manual mA-Control Considerations 3 2.4 Listing of Reference Protocols 3 2.5 Estimated Phantom Peripheral Dose .4 2.6 Organization of Dose Information in User Manuals .4 Section 3 - System Function .5 3.1 General .5 3.2 Pr
15、e-population of the Dose Check Alert Value 5 3.3 Functional Options When Switching Between Automatic Exposure Control and Manual mA Control .5 Appendix A Computed Tomography Perfusion.6 Appendix B - Automatic Exposure Control .12 Appendix C - Template for Listing of Reference Clinical Protocols 15 A
16、ppendix D - Text of FDA Letter to MITA, November 8, 2010 17 Appendix E - Estimated Phantom Peripheral Dose .20 XR 28-2013 Page iv 2013 National Electrical Manufacturers Association FOREWORD This first edition of this standard is intended to be used by medical imaging device manufacturers in the desi
17、gn and manufacture of CT scanner equipment. This standard was developed by the CT Group of the X-Ray Imaging Section of the Medical Imaging a list of parameters to check; and/or fill-in boxes for parameter values that need to be selected. 2. Default to blank values in parameter fields as a way to ge
18、t operator confirmation of ownership of the mode switch: blanks would force entry of values in order to proceed with scanning. 3. Default to reasonable values in parameter fields that would correspond to operating conditions representative of the mode before switching. 4. No scan-time switching allo
19、wed. 5. List of alternate protocols, e.g., AEC protocols that could represent an original manual-mode protocol. XR 28-2013 Page 6 2013 National Electrical Manufacturers Association Appendix A Computed Tomography Perfusion Normative Purpose of CT Perfusion Studies Computed tomography (CT) perfusion s
20、tudies are used to assess the delivery and perfusion of blood to an organ and/or its tissues. Such studies may be valuable for evaluating blood supply to neoplastic and non-neoplastic tissue (including normal and ischemic tissue). In particular, CT perfusion imaging allows the evaluation of cerebral
21、 ischemia or of the extent of angiogenesis associated with a tumor. CT perfusion should be performed only for a valid medical reason and with the minimum radiation dose necessary to achieve an adequate exam. Use of perfusion scans in children should be particularly reviewed for clinical impact and j
22、ustified. Pediatric patients are more radiosensitive than adults and have a longer post-exam life expectancy, so particular attention should be paid to displayed CTDIVOL when modifying protocols. CT perfusion imaging relies on the linear relationship between CT attenuation, expressed in Hounsfield U
23、nits (HU) and represented in a particular pixel of an image, versus the amount of iodinated contrast material perfusing the corresponding region of tissue attenuating the x-rays. Dynamic CT scanning enables the calculation of perfusion parameter maps, e.g., anatomic images where the pixel value repr
24、esents mean transit time, blood flow, blood volume, or permeability, depending upon the post-processing algorithm used. Scan technique parameters (e.g., kV, mAs) for CT perfusion studies should be set at values lower than those used for routine diagnostic scanning of the same anatomical area. Perfus
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