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  • IEC 80601-2-59:2017

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French

    Published date:  19-09-2017

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from
           ME EQUIPMENT
    201.9 Protection against mechanical HAZARDS of
           ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
           radiation HAZARDS
    201.11 Protection against excessive temperatures and
           other HAZARDS
    201.12 Accuracy of controls and instruments and
           protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
           for ME EQUIPMENT
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
           (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT
           and ME SYSTEMS
    201.101 LABORATORY ACCURACY of a SCREENING
            THERMOGRAPH
    201.102 SCREENING THERMOGRAPH ALARM CONDITIONS
    202 Electromagnetic disturbances - Requirements and tests
    206 USABILITY
    Annexes
    Annex C (informative) - Guide to marking and labeling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (normative) - CALIBRATION SOURCE
    Annex CC (informative) - Reference to the essential
             principles
    Bibliography
    Index of defined terms used in this document

    Abstract - (Show below) - (Hide below)

    IEC 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.

    General Product Information - (Show below) - (Hide below)

    Committee TC 62/SC 62D
    Development Note Stability Date: 2023. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN ISO 80601-2-56:2017 Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    CSA ISO TR 13154 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH
    PD ISO/TR 13154:2017 Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
    EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO/TR 13154:2017 Medical electrical equipment Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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