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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 063 Date of Entry 12/23/2024 
FR Recognition Number 19-53
Standard
IEC  TS 60601-4-6 Edition 1.0 2024-04
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
Scope/Abstract
This document provides practical methods to help achieve BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to the possible effects of EM DISTURBANCES throughout the EXPECTED SERVICE LIFE of ME EQUIPMENT or an ME SYSTEM.

These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by EM DISTURBANCES in ME EQUIPMENT or ME SYSTEMS.

The purpose of this document is to provide recommendations for the techniques and measures used in the design, VERIFICATION, and validation of systems, hardware, software, and firmware used in ME EQUIPMENT or ME SYSTEMS to help achieve BASIC SAFETY and ESSENTIAL PERFORMANCE
with regard to the EM DISTURBANCES that could occur throughout the EXPECTED SERVICE LIFE.
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*
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Document Issued August 2013.

Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued June 2022.

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
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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