Part B: Supplementary Information Sheet (SIS) |
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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19-19
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Standard | (Included in ASCA) |
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 |
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Scope/AbstractThis 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. |
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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FDA recognition of IEC TR 60601-4-2 Edition 1.0 2016-05 [Rec# 19-19] will be superseded by recognition of IEC TS 60601-4-2 Edition 1.0 2024-03 [Rec# 19-50].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. |