Sanyo SCP-200 manual Safety 158

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 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 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.

WhichotherfederalagencieshaveresponsibilitiesrelatedtopotentialRF healtheffects?

Certain agencies in the Federal Government have been involved in monitoring, researching or regulating issues related to human exposure to RF radiation. These agencies include the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), the National Telecommunications and Information Administration (NTIA) and the Department of Defense (DOD).

By authority of the Radiation Control for Health and Safety Act of 1968, the Center for Devices and Radiological Health (CDRH) of the FDA develops performance standards for the emission of radiation from electronic products including X-ray equipment, other medical devices, television sets, microwave ovens, laser products and sunlamps. The CDRH established a product performance standard for microwave ovens in 1971 limiting the amount of RF leakage from ovens. However, the CDRH has not adopted performance standards for other RF-emitting products. The FDA is, however, the lead federal health agency in monitoring the latest research developments and advising other agencies with respect to the safety of RF-emitting products used by the public, such as cellular and PCS phones.

The FDA’s microwave oven standard is an emission standard (as opposed to an exposure standard) that allows specific levels of microwave leakage (measured at five centimeters from the oven surface). The standard also requires ovens to have two independent interlock systems that prevent the oven from generating microwaves the moment that the latch is released or the door of the oven is opened. The FDA has stated that ovens that meet its standards and are used according to the manufacturer’s recommendations are safe for consumer and industrial use. More information is available from: www.fda.gov/cdrh.

Section 4A: Safety 158