ISO TS 10974-2018 评估有植入式医疗设备的患者进行磁共振成像的安全性

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TECHNICAL

SPECIFICATION

ISO/TS

10974

Second edition

2018-04

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 médical implantable actif

Reference number

ISO/TS 10974:2018(E)

C ISO 2018

ISO/TS 10974:2018(E)

C ISO 2018

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

CP 401·Ch.de Blandonnet 8

CH-1214 Vernier,Geneva

Phone:+41227490111

Fax:+41227490947

Email:copyright@iso.org

Website:www.iso.org

Published in Switzerland

ISO/TS 10974:2018(E)

Contents Page

Foreword ........................................................................................................................................................................... vii

Introduction ................................................................................................................................................................. ii

1 Scope ..........................................................................................................................................................................

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 documen .............................................. 6

7.1 Compliance criteria ................................................................................................................................. 6

7.2 Use of tiers ...............................................................................................................................................7

7.3 Test repors ...............................................................................................................................................7

7.3.1 Genera .......................................................................................................................................7

7.3.2 Description of the AIMD under tes ................................................................................... 7

7.3.3 Test methods and results ..................................................................................................... 7

8Protection from harm to the patient caused by RF-induced hea in ............................................... 8

8.1 Introduction ...............................................................................................................................................8

8.2 Outline of the Stage 1 four -tier approach ....................................................................................... 8

8.3 Measurement system prerequisites forall 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 spo.......................................................................................................................................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 Tier4 ............................................................... 17

8.7 Tier selection for RF-induced power deposition ........................................................................... 17

8.7.1 Genera .....................................................................................................................................17

8.7.2 Tier 1....................................................................................................................................... 17

8.7.3 Tier ..........................................................................................................................................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 deposition ............................................................................................... 24

8.11 RF-induced heating assessment flow char......................................................................................24

9 Protection from harm to the patient caused by gradient -induced device heating ............... 27

9.1 Introduction ........................................................................................................................................... 27

9.2 Testing considerations ....................................................................................................................... 28

9.2.1 Genera ................................................................................................................................... 28

9.2.2 Determination of |dB/ dt | rms exposure limits .............................................................29

9.2.3 Determination of test duration ...........................................................................................29

9.3 Test requirements ................................................................................................................................. 29

9.3.1 General ................................................................................................................................... 29

9.3.2 In vitro test phantom or other suitable container ...................................................... 30

9.3.3 Gelled solution ....................................................................................................................... 30

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标签： #医疗设备 #ISO #磁共振

摘要：

TECHNICALSPECIFICATIONISO/TS10974Secondedition2018-04AssessmentofthesafetyofmagneticresonanceimagingforpatientswithanactiveimplantablemedicaldeviceEvaluationdelasécuritédeI'imagerieparrésonancemagnétiquepourlespatientsavecundispositifmédicalimplantableactifReferencenumberISO/TS10974:2018(E)CISO2018I...

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