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Association for the Advancement of Medical instrumentation (AAMI). The final draft, a

joint effort by FDA, medical device manufacturers, and many other groups, was

completed in late 2000. This standard will allow manufacturers to ensure that cardiac

pacemakers and defibrillators are safe from wireless phone EMI. FDA has tested hearing

aids for interference from handheld wireless phones and helped develop a voluntary

standard sponsored by the Institute of Electrical and Electronic Engineers (IEEE). This

standard specifies test methods and performance requirements for hearing aids and

wireless phones so that no interference occurs when a person uses a compatible phone

and a accompanied hearing aid at the same time. This standard was approved by the

IEEE in 2000.
FDA continues to monitor the use of wireless phones for possible interactions with other

medical devices. Should harmful interference be found to occur, FDA will conduct testing

to assess the interference and work to resolve the problem.

12. Where can I find additional information?

For additional information, please refer to the following resources:
•

FDA web page on wireless phones

http://www.fda.gov/cdrh/phones/index.html

•

Federal Communications Commission (FCC) RF Safety Program

http://www.fcc.gov/oet/rfsafety

•

International Commission on Non-Ionizing Radiation Protection

http://www.icnirp.de

•

World Health Organization (WHO) International EMF Project

http://www.who.int/emf

•

National Radiological Protection Board (UK)

http://www.nrpb.org.uk/

July 18, 2001For updates: http://www.fda.gov/cdrh/phones