• NEN EN 1041 : 2008 + A1 2013

    Current The latest, up-to-date edition.

    INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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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 information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.

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

    Development Note 2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. (10/2013)
    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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