| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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6-508
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| Standard | (Included in ASCA) |
IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
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Scope/AbstractIEC 80601-2-59 Edition 2.1 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph.
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| Extent of Recognition
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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 on a scientific basis: Public health concern or hazard. |
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Transition Period
| FDA recognition of IEC 80601-2-59 Edition 2.0 2017-09 [Rec# 6-405] will be superseded by recognition of IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION [Rec# 6-508]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-405] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 6-405] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.2910 |
Continuous Measurement Thermometer
|
Class 2
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FLL
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| §880.2910 |
Thermometer, Exhaled Breath
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Class 2
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OZK
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| §880.2910 |
Fever Monitoring Kit
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Class 2
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PWW
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| §880.2910 |
Thermometer Kit
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Class 2
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PXH
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Relevant FDA Guidance and/or Supportive Publications*
1. U.S. Food and Drug Administration, Infrared Thermographs - Methods for Evaluating Laboratory Performance. In European Organization for Nuclear Research (CERN): https://doi.org/10.5281/zenodo.7883656, 2023.
2. Ghassemi, P.; Pfefer, T. J.; Casamento, J. P.; Simpson, R.; Wang, Q., Best practices for standardized performance testing of infrared thermographs intended for fever screening. PLoS ONE 2018, 13, (9), e0203302, https://doi.org/10.1371/journal.pone.0203302.
3. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
4. Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers, issued March 1993.
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 Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
