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  • BSI
    PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    Edition: 2018
    $557.44
    / user per year

Description of PD ISO/TS 10974:2018 2018

This document 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.



Standard NumberPD ISO/TS 10974:2018
TitleAssessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
StatusRevision Underway
Publication Date2018-04-20
ReplacesPD ISO/TS 10974:2012
Identical National Standard OfISO/TS 10974:2018
DescriptorsSafety engineering, Diagnosis (medical), Magnetic measurement, Electrical equipment, Radiation protection, Occupational safety, Protected electrical equipment, Electronic equipment and components, Electrical safety, Safety measures, Medical equipment, Magnetic fields, Nuclear magnetic resonance spectrometry, Clinical investigation instruments, Electrical medical equipment, Resonance
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 95455 9
PublisherBSI
Pages230

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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