• EN 61326-2-6:2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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)

    Available format(s): 

    Superseded date:  12-06-2021

    Language(s): 

    Published date:  13-01-2013

    Publisher:  European Committee for Standards - Electrical

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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)

    Committee TC 65X
    Development Note Supersedes EN 61326. (05/2006) To be read in conjunction with EN 61326-1. (05/2013) Supersedes UNE EN 61326-2-6. (02/2016)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

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

    I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
    ISO 15197:2013 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
    UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

    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
    ANSI C63.18 : 2014 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 (IEC 61326-1:2012)
    AAMI TIR 18 : 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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