EUROLAB laboratory provides testing and compliance services within the scope of ASTM F2182 standard. This test method describes a test procedure for evaluating the ∆T associated with RF power accumulation during an MR procedure involving a specific RF irradiation frequency of a passive implant.
The method allows for characterization of an implant's warming trend during a given MR procedure in a patient, rather than estimation of warming. The results can be used as input to a computational model to estimate ∆T due to the presence of that implant in a patient. The combination of test results and computational model results can then be used to help evaluate the safety of an implanted patient during an MRI examination.
ASTM F2182 Test Scope
This test method involves measuring radio frequency (RF) induced heating on or near a passive medical implant in a phantom during magnetic resonance imaging (MRI). The test method does not specify heating levels considered safe for the patient and relies on users defining their own acceptance criteria.
This test method does not address magnetically induced displacement, magnetically induced torque, image artifact, acoustic noise, tissue heating, interference between devices and other potential safety issues including but not limited to device functionality and MR system.
The amount of RF-induced temperature rise (∆T) for a given incident electric field will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. While in this test method the focus is on 1.5 tesla (T) or 3 T MR systems, ∆T for an implant in MR systems with other static magnetic field strengths or magnet designs can be evaluated with the appropriate modification of the method described here.
This test method was written for several possible RF exposure systems, including Volume RF transmit coils. Requires the exposure system to be properly characterized within the specified uncertainties in terms of local background RF exposure for the implants under test.
Values stated in SI units should be accepted as standard.
A device with deployed dimensions less than 2 cm in all directions may not need to be tested for RF induced heating as it is expected to produce less than 1.5°C ∆T at 1 T/h at 2 hour exposure. 64-MHz or 3 T/128-MHz frequencies (1, 2)2 and ANSI/AAMI/ISO 14708-3:2017). This condition does not apply when multiple replicas of the device (eg, multiple anchors) are implanted within 3 cm of the device.
Eurolab laboratory provides fast and reliable testing services within the scope of ASTM F 2182 standard.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
