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 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/ 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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