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AIM Publishes Standard for Evaluating RFID's Effects on Medical Devices
AIM, a worldwide industry association for the automatic-identification industry, has announced the release of its latest standard, known as Medical Electrical Equipment & System Electromagnetic Immunity Test for Exposure to RFID Readers. The new standard provides specialized guidance regarding the testing of non-implantable medical devices to determine if they are immune to emissions from RFID systems.
The standard is designed to provide medical device manufactures and end users with guidance on how to evaluate their devices for immunity to emissions from RFID systems. The test procedures in this document are based on experimental results from several AIM members. Test protocols are included for the major commercial implementations of RFID as standardized by ISO, including low-frequency (LF), high-frequency (HF) and ultrahigh-frequency (UHF) RFID. Both active and passive ISO RFID standards are covered.
In the early 2000s, AIM reports, members of its Healthcare Initiative Work Group (HCI) were made aware of a need for a specialized standard regarding the interactions between RFID systems and non-implantable medical devices. An ISO technical report, "ISO/IEC TR 20017," was published in 2011 that provides information about interactions between RFID and implantable medical devices. However, that document does not provide any guidance for non-implantable medical devices. The new standard developed by AIM provides that guidance for non-implantable medical devices and how to test for immunity to emissions from RFID systems.
"Publication of this standard is an important milestone. A standard methodology to evaluate medical device immunity to RFID exposure has been a need for some time," said Seth Seidman, a research electrical engineer with the U.S. Food and Drug Administration Center for Devices and Radiological Health, in a prepared statement. "This standard is currently under consideration to be recognized by FDA to help medical device manufacturers evaluate potential susceptibility to RFID exposure."
Peter J. Hawrylak, an associate professor of electrical and computer engineering at the University of Tulsa, who led the effort within AIM's Healthcare Initiative Work Group, added in the statement that the process of creating this standard has been a three-year journey "that relied on an experienced and dedicated group which consisted of experts in the fields of medical device testing, RFID system design and manufacturing, RFID system integration, as well as end-users. Thanks to their efforts, external medical device manufacturers, end-users and RFID equipment manufacturers will benefit."
To learn more about Medical Electrical Equipment & System Electromagnetic Immunity Test for Exposure to RFID Readers, or to download a copy of the publication (which costs $200), visit the AIM Marketplace, an online resource located at AIM's website.
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