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  • DIN EN ISO 9713 E : 2009

    Current The latest, up-to-date edition.

    NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Description of aneurysm clips
    5 Indication of dimensions
    6 Materials
    7 Determination of magnetic properties
    8 Closing force
    9 Marking of clips
    10 Sterilization
    11 Packaging
    12 Labelling and accompanying documentation
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC
    National Annex NA (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Explains characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition it gives a method for the measurement of closing force.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
    ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
    ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
    ISO 5832-8:1997 Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    ISO 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
    ISO 5832-7:2016 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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