Safety
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 standardwas
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
resolvethe 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/
RadiationEmittingProductsand
Procedures/HomeBusinessand
Entertainment/CellPhones/
default.htm)
Federal Communications
Commission (FCC) RF Safety
Program
http://www.fda.gov
(www.fcc.gov/oet/rfsafety)
International Commission on Non-
lonizing Radiation Protection
(http://www.icnirp.de)
World Health Organization (WHO)
International EMF Project
(http://www.who.int/emf)
Health Protection Agency
(http://www.hpa.org.uk/radiation)
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