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Team to Develop Standards for Testing RFID in Health Care

GTRI and MET Labs will test to determine the best method for measuring whether interference takes place as a result of RFID emission in both active and passive RFID technologies covering the spectrum from low-frequency (LF) to ultrahigh-frequency (UHF), by testing RF emissions from RFID products conforming to the ISO 18000-2, 18000-3, 18000-4, 18000-6 and 18000-7 RFID standards, as well as the ISO 24730-2 and 24730-5 real-time locating system (RTLS) standards. The ISO 14443 and 15693 standards and EPCglobal's Gen 2 standard will also be included, as will protocols for testing ultra-wideband (UWB) and Wi-Fi RFID devices. Testing will include distances of emission and potential interference as well.

"We think there's a strong desire for a standardized test protocol that is reflective of the real-world environment these pieces of equipment would be used in," Mullen states. "We will be working within the perimeters of creating an American national standard."

The FDA's Center for Devices and Radiological Health (CDRH) has regulatory authority over several thousand different types of medical devices, with thousands of manufacturers and device variations. The CDRH's EMC Working Group is charged with assessing the devices to identify EMC concerns, in addition to coordinating the development of a strategy to assure EMC in all appropriate devices. The CDRH has been investigating incidents of device electromagnetic interference, and working on solutions (the 1979 draft EMC standard for medical devices, for instance), since the late 1960s, when there was concern about EMI with cardiac pacemakers. (No CDRH representatives responded to RFID Journal's request for comment regarding the EMC Working Group's progress, or the AIM Global protocols project.)

"Our work will be pretty wide open to those interested in our progress," Mullen says. "I anticipate that EPCglobal will collaborate with us." This expectation, he notes, is based on the fact that EPCglobal's parent organization, GS1, is an REG member, though he's not certain of the form such collaboration would take. The REG group will also seek feedback from members of the RFID and health-care industries, he says, and plans to release several updates as the work continues.

"Our hope," Mullen states, "is that folks will utilize these test protocols, and can go to Georgia Tech or MET Labs to have their testing done." Other labs, he adds, could be used as well.

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