Medical implants

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  • ASTM F1542-94(2000), (Withdrawn 2009) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips