Safety

 

 

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

Safety

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

96

“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/cellphones/)

Federal Communications Commission (FCC) RF Safety Program (http://www.fcc.gov/oet/rfsafety)

International Commission on

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LG Electronics UX310H manual Now part of a standard, Advancement of Medical, Instrumentation AAMI, FDA, medical device