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    I.S. EN IEC 80601-2-26:2020

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

    Available format(s):  Hardcopy, PDF

    Superseded date:  17-11-2021

    Language(s):  English - French

    Published date:  29-04-2020

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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
    202 Electromagnetic disturbances – Requirements and tests
    206 USABILITY
    Annexes
    Annex AA (informative) Particular guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

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

    Committee SC 62D
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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