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AAMI TIR69

Risk management of radio-frequency wireless coexistence for medical devices and systems

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Organization: AAMI
Publication Date: 1 January 2017
Status: active
Page Count: 61
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.

Document History

AAMI TIR69
January 1, 2017
Risk management of radio-frequency wireless coexistence for medical devices and systems
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...
January 1, 2017
Risk management of radio-frequency wireless coexistence for medical devices and systems
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...

References

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