Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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6-405
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Standard | (Included in ASCA) |
IEC 80601-2-59 Edition 2.0 2017-09 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 80601-2-59:2017 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. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious diseases in general. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.2910 |
Thermometer, Electronic, Clinical
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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. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. 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. |