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
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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
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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
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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
25、 the patient caused by B0-induced malfunction . 53 19 Protection from harm to the patient caused by RF-induced malfunction 54 20 Protection from harm to the patient caused by gradient-induced malfunction 60 21 Combined fields test 74 22 Markings and accompanying documentation . 75 Annex A (informati
26、ve) Gradient vibration patent declaration form 77 Annex B (informative) Derivation of lead length factor for injected voltage test levels for gradient-induced malfunction 79 Annex C (informative) Basic MR physics 83 Annex D (informative) Gradient injection network . 85 Annex E (informative) RF injec
27、tion network . 88 Annex F (informative) Estimation of the temperature rise in vivo from determined energy deposition . 91 Annex G (informative) Methods of assessment of the temperature rise in vivo . 94 Annex H (informative) Assessment of dielectric and thermal parameters 97 Annex I (normative) Meas
28、urement system validation 100 Annex J (informative) Example of coil systems . 114 Annex K (informative) Current distribution on the AIMD as a function of the phase distribution of the incident field 115 Annex L (informative) Recipe and rationale for tissue simulating materials 119 Annex M (informati
29、ve) Generation of incident fields . 121 Annex N (informative) Dielectric parameters 125 Annex O (informative) Thermal and electrical properties of scar tissues . 127 Annex P (informative) Estimation of conservative B1and 10g averaged E-field values for Tier 1 for RF-induced heating and malfunction 1
30、28 Annex Q (informative) AIMD configurations . 134 Annex R (normative) Uncertainty evaluation 135 Annex S (informative) Guidance on gradient field interactions and test methods for pacemakers 153 Annex T (informative) Characterization of lead port interface impedance for evaluating gradient-induced
31、extrinsic electric potential effects 177 Annex U (informative) Method for in vitro measurement of gradient-induced E-field . 181 Annex V (informative) Basic physics and interactions of gradient magnetic fields with AIMDs 192 Bibliography 207 vi 2013 Association for the Advancement of Medical Instrum
32、entation ANSI/AAMI/ISO TIR10974:2012 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Availab
33、le on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR10974:2012 vii Committee repres
34、entation Association for the Advancement of Medical Instrumentation U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants The adoption of ISO/TS 10974 as an American National Standard was initiated by the U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants. This
35、 group functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO) and is administered by AAMI on behalf of the American National Standards Institute (ANSI). U.S. representatives from the U.S. Technical Advisory Group (TAG) to ISO/TC
36、150/SC 6, Active implants played an active part in developing the ISO technical specification. At the time this document was published, the U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants had the following members: Cochairs Roger G. Carrillo, MD, University of Miami Hospital
37、Ronald Reitan, Boston Scientific Corporation Members Tushar Dharampal, St Jude Medical Inc. Veronica Ivans, IMD Standards LLC Victor Kokx, Cyberonics Inc. Pierre LeRoy, CCE, MD, Delaware Pain Clinic-Newark Professional Centre Whitney Ligon, Integrated Medical Systems Michael W. Schmidt, Strategic De
38、vice Compliance Services Mitchell J. Shein, FDA/CDRH Charles B. Sidebottom, PE, Medtronic Inc. WHQ Campus Robert A Stevenson, Greatbatch Inc. Alternates Christine A. Frysz, PhD, Greatbatch Inc. James Kippola, Boston Scientific Corporation Victor Krauthamer, PhD, FDA/CDRH Stefan M. Robert, Cyberonics
39、 Inc. Curtis L. Sponberg, Medtronic Inc. WHQ Campus NOTEParticipation by federal agency representatives in the development of this technical information report does not constitute endorsement by the federal government or any of its agencies. viii 2013 Association for the Advancement of Medical Instr
40、umentation ANSI/AAMI/ISO TIR10974:2012 Background of ANSI/AAMI adoption of ISO/TS 10974:2012 As indicated in the foreword to the main body of this document (page ix), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is
41、 one of the ISO members that took an active role in the development of this ISO technical specification (TS), which was developed by ISO Technical Committee 150, Implants for surgery, Subcommittee (SC) 6, Active implants, to provide guidance on tests to be carried out on active implantable device sa
42、mples in order to characterize their interaction with magnetic and electromagnetic fields associated with an MR scanner. U.S. participation in ISO/TC 150/SC 6 is organized through the U.S. Technical Advisory Group to ISO/TC 150/SC 6, administered by the Association for the Advancement of Medical Ins
43、trumentation. Experts from the United States made a considerable contribution to this document. AAMI and ANSI procedures require that technical reports be reviewed and, if necessary, revised periodically to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have
44、 adopted other ISO standards and technical reports. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. As used within the context of this document, “shall” indicates r
45、equirements strictly to be followed to conform to the document. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the nega
46、tive form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to indicate that a course of action is permissible within the limits of the technical specification. “Can” is used as a statement of possibility and capability. Finally, “must” is used only to
47、 describe “unavoidable” situations, including those mandated by government regulation. The concepts incorporated in this document should not be considered inflexible or static. This technical information report, like any other, must be reviewed and updated periodically to assimilate progressive tech
48、nological developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this document are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arli
49、ngton, VA 22203-1633. NOTEBeginning with the ISO foreword on page ix, this AAMI TIR is identical to ISO/TS 10974:2012. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR10974:2012 ix Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be r
