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    I.S. EN 61326-2-6:2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV))

    Available format(s):  Hardcopy, PDF

    Superseded date:  12-07-2021

    Language(s):  English

    Published date:  01-01-2013

    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
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General
    5 EMC test plan
    6 Immunity requirements
    7 Emission requirements
    8 Test results and test report
    9 Instructions for use
    Annex A (normative) - Immunity test requirements
            for portable test and measurement equipment
            powered by battery or from the circuit
            being measured
    Bibliography
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    Defines minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.

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

    Development Note Supersedes I.S. EN 61326. (02/2011) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
    EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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