MRI Safety MRI Safety and Compatibility

Quality management

MR:comp endeavours to be a front runner when it comes to compliance with legislation, standards and guidelines. Therefore our test laboratory is accredited by DAkkS according to ISO 17025 for the performance of tests as specified in the list below.

Please note that due to a ruling of the German Federal Administrative Court (BVerwG) of September 19, 2018, accreditation certificates can be issued without a time limit.
The DAkkS has implemented this court decision, which concerns the omission of a time limit of accreditations. For the time being, nothing has changed with regard to the monitoring intervals, which are fixed in Rule 71 SD 0 001 published in the Federal Gazette for the various accreditation activities.

Accredited test methods

  • ISO/TS 10974 : 2018. Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
    • Clause 8, 9: Measurement of induced heating
    • Clause 10: Measurement of induced vibrations
    • Clause 11: Measurement of induced displacement force
    • Clause 12: Measurement of induced torque
    • Clause 13: Measurement of induced electrical potential
    • Clause 14, 15, 16: Measurement of induced malfunction
    • Clause 17: Measurement of combined field effects
    • Clause 18: MR conformity mark determination
  • IEC 62570:2014. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ASTM F2052-15 and ISO/TS 10974 Clause 11. Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2052-14. Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2119-07(2013). Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2182-11a. Standard Test Method for Measurement of Radio Frequency Induced Heating On and Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2213-17 and ISO/TS 10974 Clause 12. Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-06(2011). Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2503-13. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ASTM F640-12. Standard Test Methods for Determining Radiopacity for Medical Use

 

Please find our registration at the DAkkS website by clicking on the logo below:

For download: DAkkS accreditation certificate in English / German. As indicated above, from September 2018 onwards, accreditation certificates have been officially issued without a time limit.

 

MRI Safety Made in Germany - Did you know? The German DAkkS ISO 17025 accreditation of MR:comp GmbH is highest-rated worldwide for MRI safety testing. Importantly, MR:comp's accreditation annex shows the standards' numbers including the version (year of publication) of the standard,thus guaranteeing that the according test methods are up-to-date. In contrast, other labs for MR safety, if they are accredited at all, show the standards' numbers only, so it is not clear whether or not their testing methods are up-to-date. MR:comp's DAkkS accreditation is another unique and high-quality key feature of MR testing service Made in Germany.