New Developments in Standards for MRI Safety Testing of Medical Devices

Organisation for Economic Co-operation and Development, OECD Health Statistics 2014—Frequently Requested Data (2014) [Online]. http://www.oecd.org/els/health-systems/oecd-health-statistics-2014-frequently-requested-data.htm . Accessed 12 Feb 2016.

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Chen DW. Boy, 6, dies of skull injury during M.R.I., New York Times. New York; 2001. p. B1-B5.

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CDRH. MDR # 2240869-2014-02104, [Online]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3716520 (2014). Accessed 12 Feb 2016.

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Henderson JM, et al. Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson’s disease: case report. Neurosurgery. 2005;57:1063.

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ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

•• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. This standard defines the standard terms and icons, MR Safe, MR Conditional, and MR Unsafe used to label items for their safety status in the MR environment. Standard test methods ASTM F2052, F2213, F2182, and F2119 provide methods for assessing the safety of an item in the MR environment.

ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

CDRH. Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, [Online]. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm107708.pdf (2014). Accessed 12 Feb 2016.

• ISO/TS 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device, ISO, 1, rue de Varembé, Case postale 56, CH-1211 Geneva 20, Switzerland. This standard defines that hazards that must be addressed to assess the safety of an active implant and provides methods for addressing each hazard.

ISO 14708-03/Ed.2, Implants for surgery—active implantable medical devices—Part 3: implantable neurostimulators, ISO, 1, rue de Varembé, Case postale 56, CH-1211 Geneva 20, Switzerland.

AAMI. AAMI PC76/Ed.1, Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging, in development, [Online]. https://standards.aami.org/kws/public/projects/project/details?project_id=51 (2015). Accessed 12 Feb 2016.

AAMI. AAMI CI86/Ed.1, Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting, in development, [Online]. https://standards.aami.org/kws/public/projects/project/details?project_id=24 (2015). Accessed 12 Feb 2016.

ISO 14630 Non-active surgical implants—general requirements, ISO, 1, rue de Varembé, Case postale 56, CH-1211 Geneva 20, Switzerland.

ISO 14708-1 Implants for surgery—active implantable medical devices—part 1: general requirements for safety, marking and for information to be provided by the manufacturer, ISO, 1, rue de Varembé, Case postale 56, CH-1211 Geneva 20, Switzerland.

IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment, IEC, 3, rue de Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland.

IEC 60601-2-33: Particular requirements for the basic safety and essential performance of Magnetic Resonance Diagnostic Equipment, IEC, 3, rue de Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland.