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test method is now part of a standard sponsored by the
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 on
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 “compatible” 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.
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/cellphones/)
• Federal Communications Commission FCC) RF
Safety Program
(http://www.fcc.gov/oet/rfsafety
)
• International Commission on Non-Ionizing
Radiation Protection
(http://www.icnirp.de
)
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