| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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8-526
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| Standard | |
ASTM F2182-19e2
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
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Scope/Abstract1.1 This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not specify levels of heating considered to be safe to the patient and relies on users to define their own acceptance criteria.
1.2 This test method does not address other possible safety issues which include, but are not limited to: issues of magnetically-induced displacement, magnetically-induced torque, image artifact, acoustic noise, tissue heating, interaction among devices, and the functionality of the device and the MR system.
1.3 The amount of RF-induced temperature rise (delta 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 the focus in this test method is on 1.5 tesla (T) or 3 T MR systems, the delta T for an implant in MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the method described herein.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body. Testing for devices with other implantation conditions (e.g., external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes) is beyond the scope of this standard; for such devices, modifications of this test method may be necessary.
Note 1: RF-heating induced by any electrically conductive implanted device may be impacted by the presence of other metallic or otherwise electrically conductive devices present nearby.
1.5 This test method is written for several possible RF exposure systems, including Volume RF transmit coils. The exposure system needs to be properly characterized, within the stated uncertainties, in term of local background RF exposure for the implants which are tested. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Issued December 2014.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
