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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 19-19
Standard(Included in ASCA pilot)
IEC /TR 60601-4-2 Edition 1.0 2016-05
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Scope/Abstract
This part of IEC 60601 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of ELECTROMAGNETIC DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT
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.

This standard is recognized in part because:
Figure 3 is in conflict with an existing published final guidance. See "professional healthcare facility" of IV. Definitions in guidance #4 listed below.
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013.

3. 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.

4. Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use, Issued November 24, 2014.
FDA Technical Contacts
 Jeff Silberberg
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
 Donald Witters
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2483
  donald.witters@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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