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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 050 Date of Entry 09/17/2018 
FR Recognition Number 19-30
Standard
AIM Standard 7351731 Rev. 2.00 2017-02-23
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
Scope/Abstract
This document provides external medical device manufactures and end-users with guidance on how to evaluate their devices for interaction with radio frequency identification (RFID) systems. The test procedures in this document are based on experimental results from several AIM members to identify the RFID reader (operating under U.S. FCC guidelines) conditions that present the largest radio frequency (RF) spectrum. Test protocols are included for the major commercial implementations of RFID as standardized by ISO, including LF, HF, and UHF RFID. Both active and passive ISO RFID standards are covered in this document.
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.
Transition Period
FDA recognition of AIM Standard 7351731 Rev. 2.00 2017-02-23 [Rec# 19-30] will be superseded by recognition of AIM Standard 7351731 Rev. 3.00 2021-06-4 [Rec# 19-45]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-30] until July 9th, 2023. After this transition period, declarations of conformity to [Rec# 19-30] will not be accepted.
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
 Jeff Silberberg
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@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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