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Additional safety information
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(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