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  • CEI EN 61010-2-101 : 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  19-06-2023

    Language(s):  English - Italian

    Published date:  01-01-2003

    Publisher:  Comitato Elettrotecnico Italiano

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

    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)

    Committee CT 85/66
    Development Note Classificazione CEI 66-19 (12/2003) 1ED 2003 Edition is valid until 24-02-2020; and only available in combined English/Italian. (09/2017)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Superseded
    Superseded By

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

    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)
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