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  • 15/30312454 DC : 0

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    BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2017

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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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 Terminology and definitions
    201.4 General requirements
    201.5 General requirements for
            testing of 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
    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 performance requirements
    201.102 CLINICAL ACCURACY VALIDATION
    201.103 PROBES, PROBE CABLE EXTENDERS
            and PROBE COVERS
    202 Electromagnetic compatibility - Requirements and tests
    206 Usability
    208 General requirements, tests and guidance
        for alarm systems in medical electrical equipment
        and medical electrical systems
    211 Requirements for medical electrical equipment and
        medical electrical systems used in the home
        healthcare environment
    212 Requirements for medical electrical
        equipment and medical electrical systems
        intended for use in the emergency medical
        services environment
    Annexes
    Annex C (informative) - Guide to marking and
            labelling requirements for ME EQUIPMENT and
            ME SYSTEMS
    Annex AA (informative) - Particular Guidance and rationale
    Annex BB (informative) - REFERENCE TEMPERATURE SOURCE
    Annex CC (informative) - Reference to the essential
             principles of safety and performance of medical
             devices in accordance with ISO/TR 16142
    Annex DD (informative) - Terminology - alphabetized
             index of defined terms
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential Requirements
             of EU Directive 93/42/EEC
    Bibliography

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    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
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    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
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    EN 12470-5 : 2003 CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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