Standards for medical devices in MRI: Present and future

Journal of Magnetic Resonance Imaging

Volumn 26, Issue 5, 2007, Pages 1186-1189

  Woods, Terry O ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Implants; Medical devices; MR environment; MRI safety; Standard test methods; Standards

Indexed keywords

ARTIFACT; DISPLACEMENT BEHAVIOR; ELECTROCHEMICAL ANALYSIS; ENVIRONMENTAL TEMPERATURE; EVALUATION RESEARCH; GERMANY; HISTORY OF MEDICINE; HUMAN; IMAGE ANALYSIS; INTERNATIONAL COOPERATION; INTERNATIONAL STANDARD UNIT; MATERIALS TESTING; MEDICAL SOCIETY; NEUROMODULATION; NUCLEAR MAGNETIC RESONANCE IMAGING; PACEMAKER; PRIORITY JOURNAL; RADIOFREQUENCY; REVIEW; SAFETY; STANDARDIZATION; SURGICAL EQUIPMENT; TASK PERFORMANCE; UNITED KINGDOM; UNITED STATES;

EQUIPMENT AND SUPPLIES; EQUIPMENT FAILURE ANALYSIS; EQUIPMENT SAFETY; FORECASTING; GUIDELINES AS TOPIC; INTERNATIONALITY; MAGNETIC RESONANCE IMAGING; REFERENCE STANDARDS; UNITED STATES;

EID: 35848942605     PISSN: 10531807     EISSN: 15222586     Source Type: Journal    
DOI: 10.1002/jmri.21140     Document Type: Review

References (9)

1. ISO 14630. Non-active surgical implants - general requirements. New York: American National Standards Institute (ANSI) 2005.
2. ASTM F2052-06el. Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. West Conshohocken, PA: ASTM International 2006.
3. ASTM F2119-01. Standard test method for evaluation of MR image artifacts from passive implants. West Conshohocken, PA: ASTM International 2001.
4. ASTM F2182-02a. Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging. West Conshohocken. PA: ASTM International 2002.
5. ASTM F2213-06. Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. West Conshohocken, PA: ASTM International 2006.
6. ASTM F2503-05. Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. West Conshohocken, PA: ASTM International 2005.
7. U.S. FDA, CDRH (February 7. 1997). A primer on medical device interactions with magnetic resonance imaging systems. Available at: http://www.fda.gov/cdrh/ode/primerf6.html. Last accessed: August 14, 2007.
8. Woods TO. MRI safety. In: Akay M, editor. Wiley encyclopedia of biomedical engineering. Hoboken, NJ: John Wiley & Sons; 2006. p 2360-2371.
9. Baker KB, Tkach JA, Nyenhuis JA, et al. Evaluation of specific absorption rate as a dosimeter of MRI-related implant heating. J Magn Reson Imaging 2004;20:315-320.