NEMA XR 25-2010 COMPUTED TOMOGRAPHY DOSE CHECK《计算机断层扫描计量检查》.pdf
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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 25-2010Computed Tomography Dose CheckNEMA Standards Publication XR 25-2010 Computed Tomography Dose Check Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia 22
2、209 www.nema.orgwww.medicalimaging.org Copyright 2010 by the National Electrical Manufacturers Association. All rights, including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the Inter
3、national and Pan American Copyright Conventions. NOTICE AND DISCLAIMER The information in this publication was 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
4、 is unanimous agreement among every person participating in the development of this document. National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development pr
5、ocess. 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 administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does
6、 not independently test, evaluate, or verify the accuracy or completeness of any information or the soundness 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
7、, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information published herein, and di
8、sclaims 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 the performance of any individual manufacturer or sellers products or services by virtue of this standard or guide. In publishing and making
9、 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 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
10、 or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care 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
11、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 document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other sta
12、tement of compliance with any health or safetyrelated information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. XR 25-2010 Page i CONTENTS Forewordii Member Company List .iii History.iv Section 1 OVERVIEW 1 1.1 Scope.
13、1 1.2 Rationale 1 1.3 References 1 1.3.1 Normative References 1 1.4 Definitions 2 1.5 Abbreviations. 2 Section 2 DOSE NOTIFICATIONS AND DOSE ALERTS 3 2.1 Dose Notifications 3 2.1.1 Configuration. 3 2.1.2 Checking Prior to SCANNING 3 2.1.3 Audit Capability for PROTOCOLS and PROTOCOL ELEMENTS . 3 2.1.
14、4 Dose Notification Format. 4 2.2 Dose Alerts 4 2.2.1 Configuration. 4 2.2.2 Checking Prior to SCANNING 4 2.2.3 Checking Prior to Saving PROTOCOLS and Audit Capability . 5 2.2.4 Dose Alert Format . 5 ANNEX A (Informative) . 6 Copyright 2010 by the National Electrical Manufacturers Association. XR 25
15、-2010 Page ii Foreword This standard is intended to be used by medical imaging device manufacturers in the design and manufacture of CT scanner equipment. This standard was developed by the CT Group of the X-Ray Imaging Section of the Medical Imaging however, for interventional type PROTOCOL ELEMENT
16、S, alternate means may be used such as values in mGy/s. If there are no preprogrammed limits, checking is not required. The system is not required to display a notification if no corresponding NOTIFICATION VALUES have been set. To exceed a NOTIFICATION VALUE, the system shall require the operator to
17、 reconfirm the chosen PROTOCOL ELEMENTS before proceeding to the SCAN. The system shall permit the operator to enter a diagnostic reason (of up to 64 characters) at the operators discretion. The system does not have to require the input of such reason(s) in order to proceed. When a SCAN is performed
18、 that exceeds a NOTIFICATION VALUE, the system shall record the date and time, a unique study identifier, the NOTIFICATION VALUE(S) that were exceeded, and the corresponding dose index value(s) that triggered the notification and any diagnostic reason provided for proceeding after receiving a notifi
19、cation. This record shall be available for site review and audit. 2.1.3 Audit Capability for PROTOCOLS and PROTOCOL ELEMENTS The system shall be able to generate a list of all PROTOCOLS and PROTOCOL ELEMENTS with their corresponding NOTIFICATION VALUES. If the NOTIFICATION VALUE is not set for a par
20、ticular PROTOCOL ELEMENT, the list will indicate this status. The system shall generate the list on request of the user. Copyright 2010 by the National Electrical Manufacturers Association. XR 25-2010 Page 4 2.1.4 Dose Notification Format The notification shall include at least three elements: a tit
21、le, a body, and operator interactions (including a field to enter diagnostic reason(s). The title of the notification shall be the text in the following box: DOSE NOTIFICATION The body of the notification message shall identify the NOTIFICATION VALUE(S) that would be exceeded, and the corresponding
22、estimated dose index value(s), and may provide additional information for clarity. The interactions shall allow the operator to: (1) Enter diagnostic reason (optional) then confirm to proceed, or (2) Go back and adjust SCANNING PARAMETERS 2.2 DOSE ALERTS 2.2.1 Configuration Manufacturers shall provi
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