Skip to content
Please enter a keyword to search

  • UNE-EN 12006-3:1999

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    NON ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. PART 3: ENDOVASCULAR DEVICES.

    Available format(s):  Hardcopy, PDF

    Superseded date:  19-04-2011

    Language(s):  Spanish, Castilian

    Published date:  16-02-1999

    Publisher:  Asociacion Espanola de Normalizacion

    Add To Cart

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Intended performance
    5 Design attributes
    6 Materials
    7 Design evaluation
    8 Manufacturing
    9 Sterilization
    10 Packaging
    11 Information supplies by the manufacturer
    Annex A (informative) Bibliography
    Annex B (informative) Animal studies with stents
    Annex C (informative) Clauses of this European
            Standard addressing essential requirements
            or other provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Details particular requirements for endovascular devices. With reference to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. Vascular occluders are not in this standard.

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

    Committee CTN 91
    Development Note 1999 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective