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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 055 Date of Entry 12/21/2020 
FR Recognition Number 19-36
Standard(Included in ASCA pilot)
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS.

BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT
and ME SYSTEMS.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
1. Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT.
2. Subclause 8.9, Table 8 on Page 39: The citation of Note k) under "Conducted disturbances induced by RF fields" (4th Row).
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:
1. Figure 3 is in conflict with existing published final guidance. See "professional healthcare facility" of IV. Definitions in guidance #3 listed below.
2. Excluding SIP/SOP cables less than 1 m in length from the IEC 61000-4-6 test is not recognized because it is inconsistent with published literature. See Figure B.1 of #5 and first paragraph of Page 190, Chapter 10, Cables and Connectors of #6 referenced below.
Transition Period
FDA recognition of IEC 60601-1-2 Edition 4.0 2014-02 [Rec#19-8] will be superseded by recognition of IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION [Rec#19-36]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec#19-8] until December 17, 2023. After this transition period, declarations of conformity to [Rec#19-8] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013.

2. Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically2-Powered Medical Devices, Issued July 11, 2016.

3. Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use, Issued November 24, 2014.

4. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

5. IEC 61000-4-6 Edition 4.0, 2013-10 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields.

6. Kimmel, William D. and Gerke, Daryl D., Electromagnetic Compatibility in Medical Equipment, A Guide for Designers and Installers, IEEE Press and Interpharm Press, Inc., 1995
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
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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