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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 19-22
Standard
AAMI  TIR69:2017/(R2020)
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff： Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013.

Guidance for Industry and Food and Drug Administration Staff： Electromagnetic Compatibility (EMC) of Medical Devices, Issued June 6, 2022.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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