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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 057 Date of Entry 12/20/2021 
FR Recognition Number 19-44
IEEE ANSI  C63.24-2021
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
This recommended practice provides a method for in situ immunity testing of electronic devices and systems that are installed and operated at the locations where they are used, as well as where they experience interference.

The primary source of the electromagnetic (EM) energy is from transmitters that are authorized to be used, as they are in compliance with regulatory requirements. Another source is the general ambient EM environment from a variety of sources. The ambient EM environment can be characterized via a site survey using the techniques found in IEEE Std 473TM. In laboratory testing, the product is exposed to RF energy(conducted or radiated) over a wide frequency range. This cannot be done at the in situ location without a special license from regulators (e.g., the FCC). Hence, it is expected that transceivers with known frequencies allowed by the regulatory authorities are used during testing, such as licensed devices or devices using industrial, scientific, and medical (ISM) frequency bands. This is intended to replicate the immunity experience on-site where these devices/sources have been known already to be the cause of interference.

NOTE-For interference in healthcare facilities, see ANSI C63.18
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*
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
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.