• BS EN 61326-2-6 : 2013

    Current The latest, up-to-date edition.

    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

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  British Standards Institution

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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 EU 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 GEL/65/1
    Development Note To be read in conjunction with BS EN 61326-1. Supersedes 04/30116660 DC. (06/2006) Together with BS EN 61326-1, BS EN 61326-2-1, BS EN 61326-2-2, BS EN 61326-2-3, BS EN 61326-2-4, BS EN 61326-2-5, BS EN 61326-3-1 and BS EN 61326-3-2, supersedes BS EN 61326. (01/2009) Supersedes 10/30216029 DC. (07/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Superseded By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
    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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