ANSI TIR10974-2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.pdf

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1、AAMI/ISO TIR10974:2018Technical Information ReportAssessment of the safety of magnetic resonance imaging for patients with an active implantable medical deviceAdvancing Safety in Health TechnologyAAMI Technical Information Report AAMI/ISO TIR10974:2018 Assessment of the safety of magnetic resonance

2、imaging for patients with an active implantable medical device Approved 13 October 2017 by AAMI Registered 26 November 2017 with American National Standards Institute Abstract: Applies to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a ma

3、gnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation. The tests that are specified in this document are type tests that characterize interactions with the magnetic and electro

4、magnetic fields associated with an MR scanner. The tests can be used to demonstrate device operation according to its MR Conditional labelling. The tests are not intended to be used for the routine testing of manufactured products. Keywords: MRI, active implant, pacemaker, implantable defibrillator,

5、 neurostimulator, cochlear implant, artificial heart, implantable infusion pump Published by AAMI 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2018 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, s

6、torage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of a

7、ll or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regardin

8、g the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 310, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 978-1-57020-699-3 AAMI Technical In

9、formation Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, r

10、eleasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a for

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12、s as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usu

13、ally every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the 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 val

14、ue. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a

15、TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at 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 recen

16、t than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary tech

17、nical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4

18、301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Registration Publication of this Technical Report that has been registered with ANSI has been approved by the Accredited Standards Developer (AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633). This document is registered

19、 as a Technical Report according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on this technical information report are invited and should be sent to AAM

20、I, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page Glossary of equivalent standards . x Committee representation xi Background of the AAMI adoption of ISO TS 10974:2018 xii Foreword xiii Introduction . xiv 1 Scope . 1 2 Normative references . 1 3

21、 Terms and definitions . 2 4 Symbols and abbreviated terms 7 5 General requirements for non-implantable parts . 7 6 Requirements for particular AIMDs . 7 7 General considerations for application of the tests of this document . 7 7.1 Compliance criteria 7 7.2 Use of tiers . 7 7.3 Test reports 8 8 Pro

22、tection from harm to the patient caused by RF-induced heating . 8 8.1 Introduction 8 8.2 Outline of the Stage 1 four-tier approach . 9 8.3 Measurement system prerequisites for all tiers 10 8.4 Determination of RF-induced power deposition in a tissue simulating medium . 12 8.5 Proximity effect of ele

23、ctrodes from multiple leads 15 8.6 Modelling prerequisites for Tier 2, Tier 3, and Tier 4 16 8.7 Tier selection for RF-induced power deposition . 16 8.8 In vitro model validation . 20 8.9 Overall uncertainty analysis . 22 8.10 In vivo analysis of power deposition . 22 8.11 RF-induced heating assessm

24、ent flow chart . 22 9 Protection from harm to the patient caused by gradient-induced device heating 26 9.1 Introduction 26 9.2 Testing considerations . 27 9.3 Test requirements 28 9.4 Lab testing using simulated MR gradient field 30 9.5 MR scanner testing 31 9.6 Analysis of gradient heating test 31

25、10 Protection from harm to the patient caused by gradient-induced vibration 31 10.1 Introduction 31 10.2 Overview of tiers 32 10.3 MR environmental conditions . 33 10.4 General test procedure 35 10.5 Method 1 MR scanner . 36 10.6 Method 2 Shaker table 37 11 Protection from harm to the patient caused

26、 by B0-induced force 39 12 Protection from harm to the patient caused by B0-induced torque 39 13 Protection from harm to the patient caused by gradient-induced extrinsic electric potential . 39 13.1 Introduction 39 13.2 General requirements 41 13.3 Gradient pulse leakage test . 44 13.4 Gradient rect

27、ification test . 51 13.5 Gradient pulse distortion of AIMD output test 53 14 Protection from harm to the patient caused by B0-induced malfunction . 56 14.1 Introduction 56 14.2 Static field testing . 57 14.3 Test procedures . 58 15 Protection from harm to the patient caused by RF-induced malfunction

28、 and RF rectification . 59 15.1 Introduction 59 15.2 General requirements 59 15.3 Mechanisms for RF interaction with an AIMD 59 15.4 Selecting radiated vs injected test methods . 61 15.5 Injected immunity test 66 15.6 Radiated immunity test 70 15.7 Test equipment 70 15.8 Determining the peak RF inje

29、cted level using a radiated test 72 16 Protection from harm to the patient caused by gradient-induced malfunction 74 16.1 Introduction 74 16.2 General requirements 74 16.3 Selecting radiated and injected test methods 74 16.4 Radiated immunity test 75 16.5 Injected immunity test 81 17 Combined fields

30、 test . 92 17.1 Introduction 92 17.2 Test setup 92 17.3 AIMD fixation 96 17.4 Test procedure . 96 17.5 Test equipment 96 18 Markings and accompanying documentation 97 18.1 Definitions 97 18.2 Applicability of labelling requirements 97 18.3 Labelling requirements . 97 Annex A (normative) Pulsed gradi

31、ent exposure for Clause 10, Clause 13, and Clause 16 . 99 A.1 Pulsed gradient exposure for Clauses 10, 13, and 16 . 99 A.2 Determination of dB/dt for AIMD electronics module, electrodes, and extended leads 99 A.3 Injected voltage determination . 104 Annex B (informative) Derivation of lead length fa

32、ctor for injected voltage test levels for Clause 13 and Clause 16 112 Annex C (informative) Tier 1 high tangential E-field trough line resonator 120 C.1 Background 120 C.2 Design Example . 120 C.3 Performance 124 Annex D (informative) Supporting information and rationale for gradient-induced device

33、heating 127 D.1 Rationale for gradient heating |dB/dt| rms 127 D.2 Gradient heating Tier 1 waveform rationale . 130 Annex E (informative) Example RF injection network 132 Annex F (informative) Supporting information and rationale for MR-induced vibration . 134 F.1 Explanation of MR-induced vibration

34、 . 134 F.2 Tiers: MR scanner vs shaker table . 135 F.3 Clinical scanner vs research scanner 135 F.4 Potential for AIMD resonance 135 F.5 Supporting rationales . 136 F.6 Vibration measurement equipment consideration 137 Annex G (informative) Gradient vibration patent declaration form . 138 Annex H (i

35、nformative) Assessment of dielectric and thermal parameters . 140 H.1 Introduction 140 H.2 Dielectric parameters . 140 H.3 Thermal parameters . 143 Annex I (informative) RF exposure system validation method 145 I.1 Objective 145 I.2 Validation procedure 145 I.3 Standard test object definitions 146 I

36、.4 Example SAIMD exposure simulation target values 147 I.5 Test object measurement 153 I.6 Compare simulation target values to measured results . 153 Annex J (informative) MR scanner RF transmit coil . 155 Annex K (informative) Current distribution on the AIMD as a function of the phase distribution

37、 of the incident field . 157 K.1 Background 157 K.2 Phase gradients in lossy dielectrics . 157 K.3 Transfer function to determine induced heating . 158 Annex L (informative) Tissue simulating medium formulations 160 L.1 Rationale 160 L.2 HPM and LPM Recipes 160 L.3 Example preparation methods . 162

38、Annex M (informative) Generation of incident fields 164 M.1 General 164 M.2 Background 164 M.3 Uniform incident field distributions . 164 M.4 Non-uniform incident field distributions 170 M.5 Pathway modifications . 178 Annex N (informative) Dielectric and thermal tissue properties 179 Annex O (infor

39、mative) Gradient field injected testing AIMD electrode tissue impedance determination method. 183 O.1 Background 183 O.2 Theory 183 O.3 Test setup 183 O.4 Tissue interface network implementation . 186 Annex P (informative) Estimation of conservative B1 and 10 g averaged E-field values for Tier 1 for

40、 RF-induced heating and RF malfunction 188 P.1 Objective 188 P.2 Methods . 188 P.3 Results . 194 P.4 Scaling of results for Tier 1 of RF-induced malfunction 194 Annex Q (informative) AIMD configuration 196 Annex R (informative) Electrically excitable tissue stimulation, terms and definitions 197 R.1

41、 General 197 R.2 Stimulation Assessment . 197 Annex S (informative) Combined fields test 199 S.1 Example of MR protocol implementation . 199 S.2 Example of system test configuration 204 Annex T (informative) General methods for modelling dB/dt levels in MR gradient coils 206 T.1 General 206 T.2 Grad

42、ient design methods . 206 T.3 Gradient field calculation methods . 209 T.4 dB/dt calculation methods 210 Bibliography . 212 x 2018 Association for the Advancement of Medical Instrumentation AAMI/ISO TIR10974:2018 Glossary of equivalent standards International Standards adopted in the United States m

43、ay include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international des

44、ignation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced Internatio

45、nal Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. www.aami.org/standards/glossary.pdf 2018 Association for the Advancement of Medical Instrumentation AAMI/ISO TIR10974:2018 xi Committee representation Association for the Adv

46、ancement 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 AAMI U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants. This group functions as a U.S.

47、Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants played an active part in developing the ISO technical specification. At the time this

48、document was published, the AAMI U.S. Technical Advisory Group (TAG) to ISO/TC 150/SC 6, Active implants had the following members: Cochairs: Roger G. Carrillo, MD Ronald Reitan Members: Roger G. Carrillo, MD, University of Miami Hospital Tushar Dharampal, Abbott Laboratories Barbara Gibb, NeuroPace

49、, Inc. Robert Kazmierski, FDA/CDRH Whitney Ligon, Integrated Medical Systems Cedric Navarro, Advanced Bionics LLC Ron Reitan, Boston Scientific Corporation Stefan Robert, LivaNova PLC Mitchell Shein, CPR Consulting, LLC Chuck Sidebottom, PPO Standards LLC Curt Sponberg, Medtronic Inc Campus Paul Stadnik, Micro Systems Engineering Inc Bob Stevenson, Integer Alternates: Michael Childers, Abbott Laboratories Charles Farlow, Medtronic Inc Campus Christine Frysz, Integer John Jallal, Abbott Laboratories James Kippola Boston Scientific Corporation Victor Krauthamer, FDA/CDRH Dav