• ENV 12611 : DRAFT 1997

    Current The latest, up-to-date edition.

    MEDICAL INFORMATICS - CATEGORICAL STRUCTURE OF SYSTEMS OF CONCEPTS - MEDICAL DEVICES

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    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Contents
    Foreword
    0. Introduction
        0.1 Medical devices and medical device groups
        0.2 Users and uses of nomenclatures
        0.3 Organizing medical device nomenclatures
        0.4 Future applications
        0.5 Relations to CEN/TC257/SC1 standards
        0.6 Organization of the prestandard
    1. Scope
    2. Normative references
    3. Definitions
    4. Target concepts
    5. Base concepts
    6. Semantic links and associated categories
        6.1 Semantic links related to the intended purpose
        6.2 Semantic links related to the intrinsic features
        6.3 Additional semantic links
        6.4 Generative pattern
    7. Combinatorial rules
        7.1 Instance of generative pattern
        7.2 Nomenclature entries resulting from combination of
             elementary medical device groups
    8. Compliance
    Annex A (Norm.) Base concepts, associated concepts and specific
    semantic links
    Annex B (Inform.) Systematic representation of (CEN/TC257/SC1)
    medical device categories
    Annex C (Inform.) Complete systematic representation of the
    examples in the normative clauses
    Annex D (Inform.) Information on existing medical device
    nomenclatures and coding systems
    Annex E (Inform.) Users and uses of medical device coding
    systems
    Annex F (Inform.) Bibliography

    Abstract - (Show below) - (Hide below)

    Gives the requirements that are necessary for the categorial structure of systems of concepts for medical device groups. It's intended use is for organizations that are involved eith the development of maintenance of nomenclatures and coding systems for medical devices, and by database designers or information systems onvolving medical devices

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

    Comment Closes On
    Committee TC 251
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 15521:2007 Health informatics. Categorial structure for terminologies of human anatomy
    EN 12264:2005 Health informatics - Categorial structures for systems of concepts
    VDI/VDE 2426 Blatt 2:2000-05 Catalogues in maintenance and management of medical devices - Standardized device catalogue
    I.S. EN 12264:2005 HEALTH INFORMATICS - CATEGORIAL STRUCTURES FOR SYSTEMS OF CONCEPTS
    I.S. EN ISO 16278:2016 HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016)
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    VDI/VDE 2426 Blatt 1:2000-05 Catalogues in maintenance and management of medical devices - General
    06/30150535 DC : 0 EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY
    14/30297307 DC : 0 BS EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES SYSTEMS OF HUMAN ANATOMY
    AAMI ISO 15225 : 2016 MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE
    ISO/IEEE 11073-10101:2004 Health informatics Point-of-care medical device communication Part 10101: Nomenclature
    I.S. EN ISO 15225:2016 MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE (ISO 15225:2016)
    UNE-EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    EN ISO 11073-10101:2005/A1:2017 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 10101: NOMENCLATURE (ISO/IEEE 11073-10101:2004/AMD 1:2017)
    BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
    BS EN 12264:2005 Health informatics. Categorial structures for systems of concepts
    EN ISO 16278:2016 Health informatics - Categorial structure for terminological systems of human anatomy (ISO 16278:2016)
    EN 15521:2007 Health informatics - Categorial structure for terminologies of human anatomy
    DIN EN ISO 16278:2016-08 HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016)
    I.S. EN 15521:2007 HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY
    15/30280234 DC : 0 BS EN ISO 15225 - MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE
    DIN EN ISO 16278 E : 2016 HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016)
    08/30159296 DC : DRAFT APR 2008 BS EN ISO 15225 - NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
    BS EN ISO 16278:2016 Health informatics. Categorial structure for terminological systems of human anatomy
    I.S. EN ISO 11073-10101:2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 10101: NOMENCLATURE (ISO/IEEE 11073-10101:2004)
    BS EN ISO 11073-10101 : 2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 10101: NOMENCLATURE
    ISO 16278:2016 Health informatics Categorial structure for terminological systems of human anatomy
    DIN EN 15521:2008-02 HEALTH INFORMATICS - CATEGORICAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY
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