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  • UNI EN 1041 : 2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    INFORMATION SUPPLIED BY THE MANUFACTURE WITH MEDICAL DEVICES

    Available format(s): 

    Superseded date:  01-09-2011

    Language(s): 

    Published date:  01-01-2000

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements for information to be supplied by the
        manufacturer
    Annex A (informative) Bibliography
    Annex B (informative) Requirements and guidance for active
    implantable medical devices
    Annex C (informative) Requirements and guidance for medical
    devices
    Annex ZA (informative) Clauses of this European Standard
    addressing essential requirements or other provisions of
    Council Directive 90/385/EEC relating to active implantable
    medical devices
    Annex ZB (informative) Clauses of this European Standard
    addressing essential requirements or other provisions of
    Council Directive 93/42/EEC concerning medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements for the information for supplying by a manufacturer for different categories of medical devices as required by the relevant EU Directives. Does not define the language to be used for such information. Meant to complement the specified requirements of the EU Directives on medical devices in the context of defining means where certain requirements may be met.

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

    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    View more information

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