ANSI TIR10974-2012 en Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.pdf
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1、ANSI/AAMI/ISO TIR10974: 2012Technical Information ReportAssessment of the safety of magnetic resonance imaging for patients with an active implantable medical deviceAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patien
2、ts with an active implantable medical device Approved 9 July 2013 by Association for the Advancement of Medical Instrumentation Approved 2 June 2013 by American National Standards Institute Abstract: This Technical Specification contains test methods that are applicable to a broad class of active im
3、plantable medical devices (AIMDs) for the purpose of evaluating device operation against several hazards. Specifically, the document applies to implantable parts of AIMDs intended to be used in patients who undergo a magnetic resonance scan in 1.5 T, cylindrical bore, whole body MR scanners for imag
4、ing the hydrogen nucleus. The type tests that are specified in this report are intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner and can be used to demonstrate device operation according to its MR
5、 Conditional labelling. Keywords: pacemaker, ICD, circulatory support system, cochlear implant, neurostimulator, implantable infusion pump, AIMD, MRI Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 201
6、3 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior writte
7、n permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the A
8、dvancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fair
9、fax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-500-0 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumen
10、tation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedl
11、y from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the A
12、AMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another differ
13、ence is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the
14、publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to
15、 underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn a
16、t any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents
17、developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is res
18、ponsible for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American
19、 National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical
20、Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page G
21、lossary of equivalent standards vi Committee representation vii Background of ANSI/AAMI adoption of ISO/TS 10974:2012 viii Foreword . ix Introduction . x 1 Scope. 1 2 Normative references 1 3 Terms and definitions 2 4 Symbols and abbreviated terms . 7 5 General requirements for non-implantable parts
22、 . 8 6 Requirements for particular AIMDs 8 7 Protection of patients from potential hazards caused by interactions of the AIMD and MR scanners . 8 8 Test signals 9 9 General considerations for application of the requirements of this Technical Specification . 15 10 Protection from harm to the patient
23、caused by RF-induced heating . 17 11 Protection from harm to the patient caused by gradient-induced device heating 30 12 Protection from harm to the patient caused by gradient-induced vibration . 37 13 Protection from harm to the patient caused by B0-induced force 50 14 Protection from harm to the p
24、atient caused by B0-induced torque 50 15 Protection from harm to the patient caused by image artifact 51 16 Protection from harm to the patient caused by gradient-induced extrinsic electric potential 51 17 Protection from harm to the patient caused by RF rectification . 52 18 Protection from harm to
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