Norm

NVN-ISO/TS 10974:2018 en

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

181,14 219,18 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 214
Commissie Chirurgische implantaten
Gepubliceerd op 01-04-2018
Taal Engels
NEN-ISO/TS 10974 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.

Details

ICS-code 11.040.40
Engelse titel Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

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