| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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19-50
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| Standard | (Included in ASCA) |
IEC TS 60601-4-2 Edition 1.0 2024-03
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
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Scope/AbstractThis document applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively.
The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES. |
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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 |
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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.
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. |
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Transition Period
| FDA recognition of IEC TR 60601-4-2 Edition 1.0 2016-05 [Rec# 19-19] will be superseded by recognition of IEC TS 60601-4-2 Edition 1.0 2024-03 [Rec# 19-50]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-19] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 19-19] will not be accepted. |
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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: Electromagnetic Compatibility (EMC) of Medical Devices, Issued July 6, 2022.
4. Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use, Issued November 24, 2014.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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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. |
