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    I.S. EN 61010-2-101:2017

    Current The latest, up-to-date edition.

    SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    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)

    National Foreword
    FOREWORD
    1 Scope and object
    2 Normative references
    3 Terms and definitions
    4 Tests
    5 Marking and documentation
    6 Protection against electric shock
    7 Protection against mechanical HAZARDS
    8 Resistance to mechanical stresses
    9 Protection against the spread of fire
    10 Equipment temperature limits and resistance to heat
    11 Protection against HAZARDS from fluids
    12 Protection against radiation, including laser sources,
       and against sonic and ultrasonic pressure
    13 Protection against liberated gases and substances,
       explosion and implosion
    14 Components and subassemblies
    15 Protection by interlocks
    16 HAZARDS resulting from application
    17 RISK assessment
    Annexes
    Annex L (informative) - Index of defined terms
    Bibliography
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Relationship between this
             European Standard and the essential
             requirements of Directive 98/79/EC
             [OJ L 331] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Pertains to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

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

    Development Note 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 Current
    Superseded By

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

    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    EN ISO 13857:2008 Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008)
    ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
    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
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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