ISO/TS 10974:2018

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device ISO/TS 10974:2018

Publication date:   Apr 19, 2018

General information

90.92 Standard to be revised   Dec 12, 2023

ISO

ISO/TC 150/SC 6 Active implants

Technical Specification

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TS 10974:2012

NOW

PUBLISHED
ISO/TS 10974:2018
90.92 Standard to be revised
Dec 12, 2023

REVISED BY

ABANDON
ISO/CD 10974

IN_DEVELOPMENT
ISO/CD 10974