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    NA Status of Standard is Unknown

    BS EN ISO 11608-4 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 4: NEEDLE-BASED INJECTION SYSTEMS CONTAINING ELECTRONICS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 General requirements
    6 General requirements for testing
    7 Classification of ENIS
    8 Identification, marking and documentation
    9 Protection against electrical hazards
    10 Protection against mechanical hazards
    11 Protection against unwanted and excessive
       radiation hazards
    12 Protections against excessive temperatures
       and other hazards
    13 Accuracy of controls and instruments and
       protection against hazardous outputs
    14 Hazardous situations and fault conditions
    15 Programmable medical electrical systems
    16 Construction of ME equipment
    17 ME systems
    18 Requirements for Electromagnetic Compatibility (EMC)
    19 Test report
    Annex A (informative) - Rationale for statistical sampling

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

    Comment Closes On
    Committee CH/84
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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