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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 19-29
Standard
ANSI IEEE C63.27-2017
American National Standard for Evaluation of Wireless Coexistence
Scope/Abstract
This standard specifies methods for assessing the radio frequency (RF) wireless coexistence of equipment that incorporates RF communications. This standard specifies key performance indicators (KPIs) that can be used to assess the ability of the equipment under test (EUT) to coexist with other equipment in its intended operational environment
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: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Issued July 11, 2016.
FDA Technical Contacts
 Jeff Silberberg
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
 Donald Witters
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2483
  donald.witters@fda.hhs.gov
 Seth Seidman
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
General II (ES/EMC)
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