As the FDA continues to expand its unique device identification (UDI) requirements for identifying and tracking medical devices , it will increase the use of RFID tags for medical devices and concerns about RFID security in the medical industry .
However, some medical devices are susceptible to electromagnetic interference, making it possible for manufacturers and end users to challenge even the use of relatively low power RFID readers. Although there is no case record of health risks in RFID systems in hospital environments, medical device manufacturers and their customers have been urged to use their products to test the use of RFID to ensure patient safety.
To help medical device manufacturers better evaluate the applicability of RFID in their tracking applications, AIM (Global Automated Identification Industry Association) has released medical electrical equipment and system electromagnetic immunity tests for RFID reader exposure. The new standard will provide specialized guidance for testing non-implantable medical devices to determine if they are immune to RFID radios.
The testing process in the documentation is based on experimental results from several AIM members. Includes test protocols for major commercial implementations of RFID standardized by ISO, including LF, HF and UHF RFID. The standard includes active and passive ISO RFID standards.
The last ISO file (ISO 20017) provides information on the interaction between RFID and implantable medical devices such as pacemakers, but this does not cover non-implantable devices.
"The publication of this standard is an important milestone. The need to evaluate the standards of medical devices for immunization against RFID exposure has been long-lasting," said Seth Seidman, an electrical engineer at the US Department of Imaging and Radiology Equipment and Radiation Health Center. "The standard is currently being considered for FDA approval to help medical device manufacturers assess the potential susceptibility of RFID exposure."
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