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 F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- 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)
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.
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
- 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.
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