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now part of a standard
sponsored by the Association for
the Advancement of Medical
Instrumentation (AAMI). The
final draft, a joint effort by the
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.
The 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.
The FDA continues to monitor
the use of wireless phones for
possible interactions with other
medical devices. Should harmful
interference be found to occur,
the 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/Radiation-
EmittingProducts/RadiationEmittin
gProductsandProcedures/HomeB
usinessandEntertainment/CellPho
nes/default.htm)
Safety
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Safety