• NEN EN ISO 15225 : 2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Principle of structure
    5 Requirements
    6 Data file dictionary
    Annex A (normative) Device categories description
    Annex B (informative) Examples for generation of generic
                          device group terms and synonyms
    Annex C (informative) Examples of generic device group records
    Annex ZA (informative) Relationship of this document with EC
                           Directives
    Annex ZB (informative) Clauses of this European Standard
                           addressing essential requirements or
                           other provisions of Council Directive
                           90/385/EEC relating to active
                           implantable medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, healthcare providers and end users.

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    Development Note Supersedes NEN EN 1874. (05/2002)
    Document Type Standard
    Publisher Netherlands Standards
    Status Current
    Supersedes
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