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ENV 12611 : DRAFT 1997

Current

Current

The latest, up-to-date edition.

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

Published date

01-12-2013

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

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

Committee
TC 251
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
DIN V ENV 12611:1997-07 Identical
DD ENV 12611:1998 Identical
I.S. ENV 12611:1997 Identical
NEN NVN ENV 12611 : 1997 Identical
NBN ENV 12611 : 1997 Identical
UNI ENV 12611 : 1997 Identical
UNE-ENV 12611:1998 Identical

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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