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. (Find informaton about radio-opacity at the end.)

Test methods for MR safety and MR compatibility
  • ASTM F2052-06e1, 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 Environmen
  • 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
  • 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
  • ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • IEC 62570 (Document for comments) Magnetic resonance equipment for medical imaging - Instructions for marking items within the controlled access area -- result of the joint work of IEC/62B/WG45 and ASTM F04
  • ISO 14630:2008 Non-active surgical implants -- General requirements 
  • ISO 25539-1:2003 Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
  • ISO 9713:2002 Neurosurgical implants -- Self-closing intracranial aneurysm clips
  • ISO 7197:1997 Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components
  • ISO 5840:2005 Cardiovascular implants -- Cardiac valve prostheses
Standard requirements against interferences from external electrical and magnetic fields
  • EN 45502-1:1998 Active implantable medical devices. General requirements
  • EN 45502-2-1:2003 Active implantable medical devices. Particular requirements (cardiac pace makers)
Standards for safety and pulse sequences of (MRE) magnetic resonance equipment
  • IEC 60601-2-33 ed3.0 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  • IEC 62464-2 (2010-11) Ed. 1.0 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
Guidances for MR safe practice

United States of America, USA

 

Test methods for radiopacity

 

Standards considering radiopacity of medical devices are not itemised.

Standards withdrawn
  • ASTM F1542-94(2000), (Withdrawn 2009) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips
  • EN 14299 Non active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stent