Standards

MR:comp uses standardized test methods for MR safety, MR compatibility or radio-opacity according to ASTM standards. The list below informs about standards with regard to magnetic resonance safety and compatibility. Information about radio-opacity is listed at the end.

Test methods for MR safety and MR compatibility

  • ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-06(2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating On and Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2119-07, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F647 - 94(2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
  • ISO/TS 10974:2012, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Current standards and guidelines considering MR safety and MR compatibility for medical implants

  • IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
  • ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ISO 14630:2012 Non-active surgical implants -- General requirements 
  • ISO 25539-1:2003 Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
  • ISO 25539-2:2012 Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents
  • ISO 25539-3:2011 Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters
  • ISO 9713:2002 Neurosurgical implants -- Self-closing intracranial aneurysm clips
  • ISO 7197:2006 Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components
  • ISO 5840-2:2015 Cardiovascular implants -- Cardiac valve prostheses -- Part 2: Surgically implanted heart valve substitutes
  • ISO 14708-1:2014 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
  • ISO 14708-2:2012 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
  • ISO 14708-3:2008 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
  • ISO 14708-4:2008 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
  • ISO 14708-5:2010 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
  • ISO 14708-6:2010 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
  • ISO 14708-7:2013 Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems
  • ASTM F1542-94(2000), (Withdrawn 2009) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips

Standard requirements against interferences from external electrical and magnetic fields

  • EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
  • EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
  • EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
  • EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Standards and guidelines for safety of magnetic resonance equipment

  • IEC 60601-2-33:2010 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  • IEC 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
  • IEC 62464-2:2010 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
  • DIN 6876:2014-05 Operation of medical magnetic resonance systems (German norm)
  • NEMA MS 1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
  • NEMA MS 2-2008 Determination of Two-Dimensional Geometric Distotion in Diagnostic Magnetic Resonance Images
  • NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
  • NEMA MS 4-2010 Acoustic Noise Measurement Procedure fpr Diagnostic Magnetic Resonance Imaging (MRI) Devices
  • NEMA MS 5-2009 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
  • NEMA MS 6-2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)
  • NEMA MS 7-1993 (Revision 1998) Measurement Procedure for Time Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging Systems
  • NEMA MS 8-2008 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
  • NEMA MS 9-2008 Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)
  • NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging (MRI)
  • NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
  • NEMA MS 12-2010 Quantification and Mapping of Geometric Distortion for Special Applications
  • Medicines and Healthcare Products Regulatory (MHRA), Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Usa - 4th Edition - 2014, Final Draft; 2014.
  • The Royal Australian and New Zealand College of Radiologists, RANZCR MRI Safety Guidelines, Version April 2007

Test methods for radiopacity