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FDA helped develop a detailed test method to measure
electromagnetic interference (EMI) of implanted cardiac
pacemakers and defibrillators from wireless telephones.
This 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 in late 2000. This standard will
allow manufacturers to ensure that cardiac pacemakers
and defibrillators are safe from wireless phone EMI. FDA
has tested 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.Additional information on the safety of RF
exposures from various sources can be obtained from
the following organizations:
• FCC RF Safety Program:http://www.fcc.gov/oet/
rfsafety/
• .Environmental Protection Agency (EPA):http://
www.epa.gov/radiation/.
• Occupational Safety and Health Administration's
(OSHA): http://www.osha.gov/SLTC/
radiofrequencyradiation/index.html
• National institute for Occupational Safety and Health
(NIOSH):http://www.cdc.gov/niosh/emfpg.html .
• World health Organization (WHO):http://
www.who.int/peh-emf/.
• International Commission on Non-Ionizing Radiation
Protection:http://www.icnirp.de.
• National Radiation Protection Board (UK):http://
www.nrpb.org.uk.
Updated 4/3/2002: US food and Drug
Administrationhttp://www.fda.gov/cellphones
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