ISO/TS 10974:2018
(Main)Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic 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. NOTE 1 Requirements for non-implantable parts are outside the scope of this document. The tests that are specified in this document are type tests that characterize interactions with the magnetic and electromagnetic 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. NOTE 2 Modification of these tests for particular device types is left to particular product committees. NOTE 3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk. NOTE 4 Safety requirements for MR scanners can be found in IEC 60601‑2‑33. NOTE 5 The scope is limited to AIMDs that do not use sensing functions or to AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan.
Évaluation de la sécurité de l'imagerie par résonance magnétique pour les patients avec un dispositif médical implantable actif
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Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 10974
Second edition
2018-04
Assessment of the safety of magnetic
resonance imaging for patients with
an active implantable medical device
Évaluation de la sécurité de l'imagerie par résonance magnétique
pour les patients avec un dispositif médical implantable actif
Reference number
ISO/TS 10974:2018(E)
©
ISO 2018
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ISO/TS 10974:2018(E)
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ii © ISO 2018 – All rights reserved
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ISO/TS 10974:2018(E)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
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 of tiers . 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
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 .
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