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Testing an equipment for MRI Compatibility

S

shiftkoji

#1
I'm trying to do some project planning around testing our device for MRI safety. It's a class II device, but not an implantable. It's a monitoring device that would be outside the MRI machine, but in the room at the same time. It's something our customers have been asking about.

I've had trouble getting responses from test labs about this, so while I'm waiting I thought I would post here. Does anyone have any experience with testing to determine if it is MRI-conditional or MRI-safe?

What was the cost? How involved was testing?

I have not seen hard-limits for testing regarding this, and seems to be more judgement based on test conditions. If someone knows otherwise, I'd love to be pointed in the right direction.
 
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Sam Lazzara

Trusted Information Resource
#2
I do a lot of work related to MRI testing on behalf of my clients, for non-active implantable devices mostly. I have searched the globe for test labs and have obtained quotes on numerous occasions. My current recommendation based on general affordability (compared to the others) and excellent customer service is a test lab in Canada called MRIdt.

Disclaimer - I have no connection with this lab other than being a satisfied customer.
 

Sam Lazzara

Trusted Information Resource
#3
Here are some random notes regarding MRI compatibility testing.
Even though "implants" are mentioned below, the same general principles apply to any device brought into the MRI suite.

Testing can be replaced by a justification for non-magnetic materials.

Applicable Standards (versions listed may not be the latest)

ASTM F2052:2015
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F2119:2007 (2013)
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

ASTM F2182:2011a
Standard Test Method for Measurement of Radio Frequency Induced Heating near Passive Implants During Magnetic Resonance Imaging

ASTM F2213:2006 (2011)
Standard Test Method for Measurements of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2503:2013
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

US FDA Guidance:2014
Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment 


Example Design Input Requirement for Implant
7.3.3 Implant Magnetic Resonance Imaging (MRI) Compatibility: Implant shall be labeled as “MR Conditional”, meaning it has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. MR-imaging artifacts where the device is deployed is acceptable if disclosed in IFU.
MR-Conditional Labeling (ASTM F2503) requirement is for IFU to disclose specified MRI environment for which implant can be safely scanned. Determine MRI-compatibility labeling requirements by testing compatibility with 3-Tesla MRI system to obtain experimental data as described below.
· Magnetically Induced Displacement Force per ASTM F2052
· Magnetically Induced Torque per ASTM F2213
· Heating by RF Fields per ASTM F2182
· Image Artifact per ASTM F2119
 
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