HEALTIS SAS

ISO/IEC 17025 accredited* MRI safety & compatibility testing

ASTM Standards (Passive Medical Devices)
ASTM F2052 Measurement of the displacement force generated by the static magnetic field
ASTM F2213 Measurement of the torque generated by the static magnetic field
ASTM F2182 Measurement of the Radio Frequency induced heating
ASTM F2119 Evaluation of the image artifacts generated by the presence of the device
ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 

ISO / TS 10974 (Active Medical Devices)
Clause 8 Assessment of radiofrequency heating
Clause 9 Assessment of gradient field heating
Clause 10 Evaluation of vibrations
Clause 11 Measurement of the displacement force induced by the static magnetic field
Clause 12 Measurement of the magnetic torque induced by the static magnetic field
Clause 13 Assessment of gradient field induced currents
Clause 14 Assessment of malfunctions due to the static magnetic field
Clause 15 Assessment of radio frequency induced malfunctions
Clause 16 Assessment of gradient field induced malfunctions
Clause 17 Assessment of the combined field effects (possibility to monitor implant activity)
Clause 18 Evaluation of the image artifacts generated by the presence of the device

*HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr)

HEALTIS is a leader in evaluating the safety of medical devices introduced in the MRI environment. Our experts participate in the development of standards in the field. This allows us to be at the forefront of knowledge in the evaluation of interactions between MRI and medical devices but also to anticipate changes. Benefit from our expertise through our numerous technical and regulatory assistance services. 

Proposed Risk Assessment Strategy
Determination of the worstcases
Writing Rationals
Interpretation of results and marking of the device according to ASTM F2503
Audit of your risk assessment in MRI and proofreading of documents

Medical devices may experience an increase in temperature as a result of the radio frequencies present during an MRI exam.

Evaluation of this radio frequency heating is a complex subject which can be simplified and assisted by the use of numerical modeling. HEALTIS is expert in this field and can accompany you:

determine worstcases in ranges of passive devices with multiple configurations
determine the points of maximum heating on a device
specific studies requiring the modeling of radiofrequency heating

Offering a device compatible with an MRI environment can be a real competitive advantage. For some products it has even become indispensable.

Taking into account the safety aspect in MRI in the design of a product is complex for the manufacturer. This requires skills that are not always available internally: in-depth knowledge of MRI, interactions between electromagnetic waves of MRI and devices, knowledge of material physics and electronics. As experts in the field, our engineers and doctors can guide you during these phases of R & D.This support for R & D can take different forms, which we systematically adapt to your needs. Such as,

• performing preliminary tests for a first discovery of potential difficulties related to the introduction of your device in MRI or to quickly assess the behavior of a prototype or component
• assistance in the design of the device to guide you on the choice of components, materials, design recommendations, ….
• studies by numerical modeling

Wishing to share our knowledge, our training aims to help you develop skills in assessing the safety of MRI devices. We discuss the technical, scientific and regulatory aspects of the safety and compatibility of medical devices in the MRI environment. Here are some examples of themes we can deal with:

• the risks generated by the interactions between the Medical Device and the electromagnetic waves of the MRI
• applicable regulations and test methods for evaluating the safety of a Medical Device in MRI
• integration of MRI compatibility into product design
  

These training courses are tailor-made to be adapted to your problem, your products and your level of knowledge.