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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 058 Date of Entry 02/07/2022 
FR Recognition Number 19-45
Standard
AIM  Standard 7351731 Rev. 3.00 2021-06-04
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
Scope/Abstract
The purpose of this AIM Standard document is to provide test methods and test levels for the evaluation of the electromagnetic immunity of (non-implantable) medical electrical equipment and systems to electromagnetic emissions from radio frequency identification (RFID) readers.

For the purposes of this AIM Standard, other technologies such as Wi-Fi and ultra-wideband (UWB) are not considered. It focuses on the most common RFID technologies currently deployed in healthcare environments.

This document can also provide guidance to RFID solution designers and medical facility engineers and administrators, which can help them determine whether the medical electrical equipment or system and the RFID solution environment are compatible.
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*
1. 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 2016.

2. Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 2013

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 Contacts
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
 Jeff Silberberg
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
Standards Development Organization
AIM AIM, Inc. http://www.aimglobal.org
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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