AIM, the worldwide industry association for the automatic identification industry, providing information, educational resources and standards to providers and users of these technologies for nearly half a century, announced Wednesday the release of Medical Electrical Equipment & System Electromagnetic Immunity Test for Exposure to RFID Readers, a new standard that provides specialized guidance on the testing of non-implantable medical devices to determine if they are immune to emissions from radio frequency identification (RFID) systems.
The standard provides medical device manufactures and end-users with guidance on how to evaluate their devices for immunity to emissions from radio frequency identification (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 LF, HF, and UHF RFID. Both active and passive ISO RFID standards are covered in this document.
Members of AIM’s Healthcare Initiative Work Group (HCI) were made aware of a need for a specialized standard from the interactions identified in the early 2000s between RFID systems and non-implantable medical devices.
An ISO technical report, ISO 20017 (ISO/IEC TR 20017:2011), was published in 2011 that provided information about interactions between RFID and implantable medical devices. However, ISO 20017 does not provide any guidance for non-implantable medical devices.
“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, Research Electrical Engineer, Center for Devices and Radiological Health at the U.S. Food and Drug Administration. “This standard is currently under consideration to be recognized by FDA to help medical device manufacturers evaluate potential susceptibility to RFID exposure.”
The new standard developed by AIM provides guidance for non-implantable medical devices and how to test for immunity to emissions from RFID systems.
“The process of creating this standard has been a long, hard and thorough journey over a three year period 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,” said Peter Hawrylak, Associate Professor of Electrical and Computer Engineering at the University of Tulsa, who led the effort within the Healthcare Initiative group.