Regulatory information
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 smartphone EMI.
FDA has tested hearing aids for interference from handheld wireless smartphones 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 smartphones so that no interference occurs when a person uses a “compatible” smartphone 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 smartphones 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.
Which other federal agencies have responsibilities
related to potential RF health effects? 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
agencies with respect to the safety of
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.
The EPA has, in the past, considered developing federal guidelines for public exposure to RF radiation. However, EPA activities related to RF safety and health are presently limited to advisory functions. For example, the EPA now chairs an Inter- agency Radiofrequency Working Group, which coordinates RF
OSHA is responsible for protecting workers from exposure to hazardous chemical and physical agents. In 1971, OSHA issued a protection guide for exposure of workers to RF radiation [29 CFR 1910.97]. However, this guide was later ruled to be only advisory and not mandatory. Moreover, it was based on an earlier RF exposure standard that has now been revised. At the present time, OSHA uses the IEEE and/or FCC exposure guidelines for enforcement purposes under OSHA's “general duty clause” (for more information see:
index.html.
NIOSH is part of the U.S. Department of Health and Human Services. It conducts research and investigations into issues related to occupational exposure to chemical and physical agents. NIOSH has, in the past, undertaken to develop RF exposure guidelines for workers, but final guidelines were never adopted by the agency. NIOSH conducts
The NTIA is an agency of the U.S. Department of Commerce and is responsible for authorizing Federal Government use of the RF electromagnetic spectrum. Like the FCC, the NTIA also has
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