| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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19-30
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| 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 |
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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. |
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| Extent of Recognition
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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. |
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Relevant FDA Guidance and/or Supportive Publications*
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.
Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013 |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
