National Physical Laboratory

Safety of Implanted Devices in Magnetic Resonance Imaging (MRI) Environments

1.5 T MR scanner
NPL has a laboratory based system that
recreates the RF field from a 1.5 T MR scanner

Any medical devices to be used in a magnetic resonance (MR) environment need to comply with relevant standards, e.g. In the case of implanted devices an MR label should be obtained marking these as MR Safe, MR Conditional or MR Unsafe [1]. The onus is on device manufacturers to provide as much information as possible for the clinical team to make an informed decision on patient safety.

NPL has partnered with Guy's and St Thomas' NHS Foundation Trust and PA Consulting Group to offer a rounded selection of services for medical device manufacturers to assist them in meeting regulatory requirements.

Services

Standard services offered include:

  • Evaluation of RF-induced heating in the vicinity of the implant [2]
  • Evaluation of displacement force on the implant [3]
  • Evaluation of torque on the implant [4]
  • Evaluation of image artefacts due to the implant [5]
  • Computer simulation of implanted devices using realistic human models to assess their effects and performance in-vivo
  • Early-stage MR Compatibility consultancy for products still in the development cycle

Measurements taken are traceable to national standards.

Bespoke services are available upon request.

Download flyer Adobe Acrobat PDF file
Magnetic Resonance Compatibility of Medical DevicesConsultancy service for the manufacturers of medical devices to assist in meetingregulatory requirements

Contact

Customer Service tel: 020 8943 6796
E-mail: rf_enquiries@npl.co.uk


References

[1] ASTM International Standard F2503, 'Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment', 2013

[2] ASTM International Standard F2182, 'Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging", 2011

[3] ASTM International Standard F2052, 'Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment', 2014

[4] ASTM International Standard F2213, 'Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment', 2006

[5] ASTM International Standard F2219, 'Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants', 2007

Last Updated: 5 May 2016
Created: 8 Oct 2014

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