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 F1542-94, (Reapproved 2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips
- ASTM F2052-06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-06, 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/PRF TS 10974, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device; to be published 2012
Current standards and guidelines considering MR safety and MR compatibility for medical implants
- ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ISO 14630:2005 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
- EN 14299 Non active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stent
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)
FDA guidelines for Industry and Staff considering MR testing for medical devices
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, 2010
- Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, 2008
- Medical Devices with Sharps Injury Prevention Features, 2005
- Intravascular Administration Sets Premarket Notification Submissions [510(k)], 2008
- Implantable Radiofrequency Transponder System for Patient Identification and Health Information, 2004
- Implantable Middle Ear Hearing Device, 2003
- Cardiovascular Intravascular Filter 510(k) Submissions, 1999
Guidelines contain MR safety recommendations in general up to detailed information and links to ASTM test methods.
Standard for safety of 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
Guidances for MR safe practice
United States of America, USA
- American College of Radiology (ACR), Guidance Document on MR Safe Practices: 2007
- Joint Commission, Preventing accidents and injuries in the MRI suite, Issue 38, 2008
Test methods for radiopacity
- ASTM F640-07 Standard Test Methods for Determining Radiopacity for Medical Use
- DIN 13273-7 Catheters for medical use. Part 7: Determination of the x-ray attenuation of catheters. Requirements and testing
Standards considering radiopacity of medical devices are not itemised.