PD IS0/TS 10974:2018 BSi Standards Publication .Versioncorre ImperialCollegeLondon, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device bsi. PUBLISHED DOCUMENT PD IS0/TS 10974:2018 National foreword This Published Document is the UK implementation of IS0/TS 10974:2018. It supersedes PD IS0/TS 10974:2012, which is withdrawn. ,Versioncorrectasof21/04/2018 The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @ The British Standards Institution 2018 Published by BSI Standards Limited 2018 ISBN 9780580954559 ICS 11.040.40 Imperial College London, Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 April 2018. Amendments/corrigenda issued since publication Date Text affected Licensed copy:Imperial College PDIS0/TS10974:2018 TECHNICAL ISO/TS SPECIFICATION 10974 Second edition 2018-04-23 Imperial College London,Versioncorrectas of 21/04/2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device Evaluation de la sécurité de I'imagerie par résonance magnétique pour les patients avec un dispositif medical implantable actif Licensedcopy:ImperialCollege Reference number AX IS0/TS10974:2018(E) SO @ IS0 2018 PD IS0/TS 10974:2018 IS0/TS10974:2018(E) Versioncorrectasof21/04/2018 Imperial College London, College :Imperial Licensed copy: COPYRIGHTPROTECTED DOCUMENT @ IS0 2018, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or ISO's member body in the country of the requester ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +4122 749 09 47 [email protected] www.iso.org ii @ IS0 2018 - All rights reserved PD IS0/TS 10974:2018 IS0/TS 10974:2018 Contents Page Foreword .vii Introduction .. vi 1 Scope. .1 Versioncorrectasof21/04/2018 2 Normative references .1 3 Terms and definitions .1 4 Symbols and abbreviated terms. .6 5 General requirements for non-implantable parts .6 6 Requirements for particular AIMDs .6 7 General considerations for application of the tests of this document 6 7.1 Compliance criteria .6 7.2 Use oftiers 7 7.3 Test reports 7 7.3.1 General. 7 7.3.2 Description of the AIMD under test 7 7.3.3 Test methods and results.. 7 ImperialCollegeLondon, 8 Protection 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 8 8.3 Measurement system prerequisites for all tiers .10 8.3.1 RF field source 10 8.3.2 Tissue simulating phantom 10 8.3.3 Definition of power deposition .12 8.3.4 Measurement system validation 12 8.4 Determination of RF-induced power deposition in a tissue simulating medium 12 8.4.1 General.... .12 8.4.2 Determine location of hot spots around the AIMD .13 8.4.3 Determination of spatial (3D) distribution of power deposition for each hot spot 13 8.4.4 Determine the final power deposition .14 8.5 Proximity effect of electrodes from multiple leads 16 8.6 Modelling prerequisites for Tier 2, Tier 3, and Tier 4 16 8.7 Tier selection for RF-induced power deposition.. 17 8.7.1 General. 17 8.7.2 Tier 1 17 8.7.3 Tier 2 18 8.7.4 Tier 3 19 8.7.5 Tier 4 20 8.8 In vitro model validation 21 8.9 Overall uncertainty analysis. 23 8.10 In vivo analysis of power depos