PMID- 17969160
OWN - NLM
STAT- MEDLINE
DCOM- 20080122
LR  - 20071105
IS  - 1053-1807 (Print)
IS  - 1053-1807 (Linking)
VI  - 26
IP  - 5
DP  - 2007 Nov
TI  - Standards for medical devices in MRI: present and future.
PG  - 1186-9
AB  - The purpose of this review is to define the current standards addressing safety 
      of medical devices in MRI and to describe ongoing standards development efforts. 
      The American Society for Testing and Materials (ASTM International) began 
      developing standard test methods for determining the MR safety of medical devices 
      in MRI in 1997. To date, five ASTM standards addressing testing and marking 
      medical devices and other items for use in the MR environment have been 
      published. International Standards Organization (ISO) 14630, the general 
      requirements standard for nonactive surgical implants, is currently being revised 
      to include information about MR safety of passive implants and to reference the 
      ASTM standards. To address the unique safety issues of active implants, and in 
      particular, active implants with leads, like pacemakers and neurostimulators, a 
      joint working group between ISO TC150/SC6 on active implants and International 
      Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for 
      medical diagnosis is working to develop a technical specification for active 
      implantable medical devices (AIMDs) in MRI. While much progress has been made, 
      work still needs to continue to develop a complete body of test methods to allow 
      the evaluation of the safety of medical devices in the MR environment.
FAU - Woods, Terry O
AU  - Woods TO
AD  - U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA. 
      terry.woods@fda.hhs.gov
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Magn Reson Imaging
JT  - Journal of magnetic resonance imaging : JMRI
JID - 9105850
SB  - IM
MH  - Equipment Failure Analysis/*standards
MH  - Equipment Safety/*standards/*trends
MH  - Equipment and Supplies/*standards
MH  - Forecasting
MH  - *Guidelines as Topic
MH  - Internationality
MH  - Magnetic Resonance Imaging/*instrumentation/*standards
MH  - Reference Standards
MH  - United States
RF  - 9
EDAT- 2007/10/31 09:00
MHDA- 2008/01/23 09:00
CRDT- 2007/10/31 09:00
PHST- 2007/10/31 09:00 [pubmed]
PHST- 2008/01/23 09:00 [medline]
PHST- 2007/10/31 09:00 [entrez]
AID - 10.1002/jmri.21140 [doi]
PST - ppublish
SO  - J Magn Reson Imaging. 2007 Nov;26(5):1186-9. doi: 10.1002/jmri.21140.