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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 050 Date of Entry 09/17/2018 
FR Recognition Number 19-31
Standard
IEEE ANSI  C63.15-2017 (Revision of ANSI C63.15-2010)
American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
Scope/Abstract
This immunity testing and test instrumentation specifications recommended practice complements the procedures for making emission measurements as specified in ANSI C63.4 and in ANSI C63.10. These immunity test methods can be of use to manufacturers who want to maximize product reliability and reduce customer complaints by improving the immunity of their products, beyond that required by applicable regulations, or by correcting problems experienced in deployment that are not related to regulatory requirements. This recommended practice generally covers the frequency range 30 Hz to 10 GHz.
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.


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
 Jeff Silberberg
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
Standards Development Organizations
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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