Assessing the MRI safety of your products ...
We offer a wide range of tests for evaluating the safety of medical devices in the MRI environment, here is a non-exhaustive list:
- ASTM tests
- 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
- ISO / TS 10974
- 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
- Other tests
- Measurement of magnet demagnetization according to AAMI CI86
- Extraction of the magnet from a cochlear implant according to AAMI CI86
Each device is unique, and our expertise allows us to adapt to most situations. We design and carry out tailor-made tests to meet any particular demand, especially when the normative methods are not directly applicable (non-implantable devices for example). So contact us to discuss your project.
Our quality policy allows us to guarantee the reliability of our test results and the conformity of our practices with the normative requirements.
HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr).
Benefit from our support!
You will be in touch with one of our experts from the first contact. They will communicate with you all of the necessary information to understand the foundations of our business and the relevant regulatory framework. They will take into account your needs to bring you an adapted response to your inquiry.
Throughout the realization of your project we guarantee a cleat communication and strong support. You will have all the information you need to understand our work and if you wish, may attend the realization of your tests.
Where necessary, our numerical modeling and technical and regulatory assistance activities will assist you in defining a relevant risk assessment strategy, identifying and justifying the worst cases, interpreting test results, and ensuring the labelling of your products according to ASTM F2503 and the relevant literature.
To learn more about the safety and compatibility of medicals devices in MRI, you also have the opportunity to participate in our trainings.
Optimum means of testing
Your tests will be performed on MRIs, by qualified engineers, PhDs or test technicians.
Our instruments are selected or designed by our team of experts to meet all the constraints of the MRI environment and the normative requirements. All instruments are qualified, calibrated and regularly monitored.
We additionally have available a probe for measuring signals during an MRI exam; this allows, for example, to monitor the activity of an active implant in the MRI environment during an MRI exam.
An Experienced Laboratory
HEALTIS has performed safety and MRI compatibility tests on a large number of implantable and non-implantable devices. Which, for the most part, have been introduced to the US, European, or Asian markets.More than 500 trials have already been conducted in our laboratory for clients from all backgrounds and a variety of devices. Here are some examples of devices we have tested:
- Passive Implantable Devices
- Joint prostheses (hip, knee, shoulder, finger, etc.)
- Spinal implants
- Stents, ballons
- Implantable chambers
- Active Implantable Devices
- Heart valves
- Cochlear implants
- Pacemakers, implantable defibrillators
- Semi-Implantable Devices
- Intracranial pressure sensors
- Suture anchors
- Non-Implantable Devices
- Monitoring devices
- RFID Tags
- Gas bottle and regulators
- Patient supports