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AAMI TIR69
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AAMI TIR69 2017 Edition, February 28, 2017 Risk management of radio-frequency wireless coexistence for medical devices and systems
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Description / Abstract:
General
Purpose and intent
This technical information report (TIR) provides information, guidance, and best practices for supporting the risk management process as it applies to the ability of medical devices and systems that use radio-frequency (RF) wireless technology to coexist and operate within the electromagnetic environment in the area of the device's intended use.
The TIR provides a method to test for wireless coexistence and a process to document and communicate those results to designers, manufacturers, regulatory bodies and agencies, and users of wireless medical devices and systems. Issues for wireless medical device coexistence include:
• the type of hazardous situation that might occur,
• the potential consequences,
• mitigating and managing hazards,
• and how to test those mitigations.
This document is intended to address regulated medical devices that incorporate wireless technology. The focus is on the risks related to the wireless functions of the medical device or system. The use cases presented and the risks assessed herein are intended to address such systems and aid device manufacturers and others in applying mitigating or compensating controls. Moreover, the principles and procedures mentioned here can be applicable to other portions of the wireless systems to which the medical device is connected.
It is important to note that much of the clinical functionality of current and future wireless medical devices can be, and are being, enhanced and replaced by wireless connections to networks external to the devices and systems designed and tested by the medical device manufacturer. In these circumstances, the data extracted from the medical device is transmitted through, and in some cases post-processed by, systems outside the direct control of the medical device in question. Consequently, transfer of the data through these peripheral systems can present additional risks not considered in this document but should be considered in a comprehensive risk management process or communicated to the customer if outside of the manufacturer's control. Such additional risks are outside the scope of this document and generally outside the control of the medical device manufacturer and in some cases outside the control of the user facility. Therefore, it is recommended that any third party integrating wireless medical devices into larger systems assess the risks outlined in this document and utilize this understanding in planning a deployment. By applying appropriate regulatory guidelines or consensus standards to integrate mitigation and compensating controls, the level of operational coexistence and reliability demonstrated through testing can be provided in actual use.
Scope
This TIR applies to medical devices and systems (also known as medical electrical equipment) that incorporate 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.
When evaluating the intended use environment for a wireless medical device the emissions from both intentional and unintentional radiators (medical and non-medical equipment) should be considered, depending on the frequency band of the medical device wireless operation. For example, a medical device that operates below 300 kHz should consider emissions from an intentional radiator (emitter) like radio frequency identification (RFID) and localized spurious (unintentional) emissions from switch mode power supplies embedded in medical and non-medical equipment.
Intended audience
The intended audience for this TIR includes the following:
• Medical device designers and manufacturers
• Wireless test engineers and test laboratories
• Healthcare organizations
• Agencies and organizations responsible for overseeing the safety and effectiveness of medical devices
Purpose and intent
This technical information report (TIR) provides information, guidance, and best practices for supporting the risk management process as it applies to the ability of medical devices and systems that use radio-frequency (RF) wireless technology to coexist and operate within the electromagnetic environment in the area of the device's intended use.
The TIR provides a method to test for wireless coexistence and a process to document and communicate those results to designers, manufacturers, regulatory bodies and agencies, and users of wireless medical devices and systems. Issues for wireless medical device coexistence include:
• the type of hazardous situation that might occur,
• the potential consequences,
• mitigating and managing hazards,
• and how to test those mitigations.
This document is intended to address regulated medical devices that incorporate wireless technology. The focus is on the risks related to the wireless functions of the medical device or system. The use cases presented and the risks assessed herein are intended to address such systems and aid device manufacturers and others in applying mitigating or compensating controls. Moreover, the principles and procedures mentioned here can be applicable to other portions of the wireless systems to which the medical device is connected.
It is important to note that much of the clinical functionality of current and future wireless medical devices can be, and are being, enhanced and replaced by wireless connections to networks external to the devices and systems designed and tested by the medical device manufacturer. In these circumstances, the data extracted from the medical device is transmitted through, and in some cases post-processed by, systems outside the direct control of the medical device in question. Consequently, transfer of the data through these peripheral systems can present additional risks not considered in this document but should be considered in a comprehensive risk management process or communicated to the customer if outside of the manufacturer's control. Such additional risks are outside the scope of this document and generally outside the control of the medical device manufacturer and in some cases outside the control of the user facility. Therefore, it is recommended that any third party integrating wireless medical devices into larger systems assess the risks outlined in this document and utilize this understanding in planning a deployment. By applying appropriate regulatory guidelines or consensus standards to integrate mitigation and compensating controls, the level of operational coexistence and reliability demonstrated through testing can be provided in actual use.
Scope
This TIR applies to medical devices and systems (also known as medical electrical equipment) that incorporate 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.
When evaluating the intended use environment for a wireless medical device the emissions from both intentional and unintentional radiators (medical and non-medical equipment) should be considered, depending on the frequency band of the medical device wireless operation. For example, a medical device that operates below 300 kHz should consider emissions from an intentional radiator (emitter) like radio frequency identification (RFID) and localized spurious (unintentional) emissions from switch mode power supplies embedded in medical and non-medical equipment.
Intended audience
The intended audience for this TIR includes the following:
• Medical device designers and manufacturers
• Wireless test engineers and test laboratories
• Healthcare organizations
• Agencies and organizations responsible for overseeing the safety and effectiveness of medical devices