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ISO/TS 10974:2012

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

General information

Withdrawn from 19.04.2018
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
19.04.2018
Main
ISO/TS 10974:2018
Main
ISO/TS 10974:2012
ISO/TS 10974:2012 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who might undergo a magnetic resonance scan in 1,5T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus.
The tests that are specified in ISO/TS 10974:2012 are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner.
ISO/TS 10974:2012 contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards.

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PDF
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Standard monitoring
English (PDF 105 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English