AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems
This Technical Information Report applies to medical devices and systems (also known as medical electrical equipment) that incorporate Radio Frequency (RF) wireless technology used to perform or control a medical function or to communicate medical data. This includes wireless technology whose operation and function directly support the medical device's intended use, as it relates to the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
TIR 69 provides manufacturers and users with a consensus process and guide to help determine and manage the risks associated with the coexistence of wireless medical devices and systems with other wireless products that can operate in the same location or vicinity.
Types of medical devices that incorporate wireless technology include:
- implanted cardiac pacemakers and cardioverter defibrillators,
- numerous physiological monitoring devices,
- implantable neurostimulators,
- drug and insulin infusion devices,
- diagnostic imaging systems, and
- a wide range of other medical devices.
The TIR itself provides context for the wireless challenge facing healthcare.
Noting the increasingly crowded spectrum, the document states: “The potential for RF wireless devices to affect and potentially interfere with other transmissions is growing and is a regular occurrence in some frequency bands. …RF wireless technology is being put to use in an ever-expanding variety of applications. Healthcare delivery is a full participant in this trend, making it increasingly important that the hazards and associated risks related to the ability of wireless medical devices and systems to coexist are effectively and efficiently managed.”
Published: February 2017; 57 pages
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