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  • CSA C22.2 No. 61010.2.101 : 2015

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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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

    Withdrawn date:  28-08-2019

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  Canadian Standards Association

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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

    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)

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn
    Superseded By
    Supersedes

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

    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
    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
    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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