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  • CEI EN 61326-2-6 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-04-2022

    Language(s):  English - Italian

    Published date:  01-01-2014

    Publisher:  Comitato Elettrotecnico Italiano

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

    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 EC Directives

    Abstract - (Show below) - (Hide below)

    Describes 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)

    Committee CT 65
    Development Note Classificazione CEI 65-102. To be used in conjunction with CEI EN 61326-1. (02/2007) Supersedes CEI EN 61326. (05/2008)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Superseded
    Superseded By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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