What is the ASTM F2182 Testing Standard?

ASTM F2182 is the standard test method for measuring radiofrequency (RF)-induced heating on or near passive implants during magnetic resonance imaging (MRI).

Latest Version

The latest version of this standard is ASTM F2182-19e2.

Testing Services and Compliance

Following the ASTM F2182 standard, China’s JJR Laboratory provides precise and compliant testing services for RF-induced heating on or near passive implants. This test method not only describes the procedure for evaluating the relationship between RF power deposition and temperature change (ΔT) in detail but also accurately reflects the heating trend of implants in actual MRI procedures, rather than making a simple estimation.

Application of Test Results

The test results can be used as input for computational models to predict temperature changes (ΔT) caused by implants in a patient's body. By combining test results with computational models, we can provide strong support for assessing the safety of implanted patients during MRI examinations.

Scope of the Test Method

This test method focuses on measuring RF-induced heating on or near passive medical implants in a phantom during MRI. However, it is important to note that:

- This method does not define an acceptable heating level for patient safety but allows users to set their own acceptance criteria.

- The test does not address other potential safety concerns such as magnetically induced displacement, image artifacts, acoustic noise, or tissue heating.

Factors Affecting RF-Induced Heating

Under a specific incident electric field, the RF-induced temperature rise (ΔT) depends on the RF frequency, which is closely related to the static magnetic field strength of the MRI system.

- This test method primarily focuses on 1.5 Tesla (T) or 3T MRI systems.

- With appropriate modifications, it can also be used to evaluate temperature changes (ΔT) in implants under different static magnetic field strengths or magnet designs.

Applicability to Different RF Exposure Systems

This test method applies to various RF exposure systems, including volume RF transmit coils. It requires appropriate characterization of the local background RF exposure in relation to the tested implant within a specified uncertainty range.

- SI units are accepted for standard values.

Special Considerations for Small Devices

Devices smaller than 2 cm in all unfolded directions may not require RF-induced heating testing, as they are expected to produce a temperature change (ΔT) of less than 2°C over 1.5 hours of exposure at a rate of 1T/h.

- However, if multiple copies of a device (such as multiple anchors) are implanted within 3 cm of each other, this condition no longer applies.