ENV 12611:1997

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

This European Prestandard specifies the necessary requirements (clauses 5, 6 and 7) for the categorial structure of systems of concepts for medical device groups (clause 4). This prestandard is meant to be used by organizations involved with the development or maintenance of nomenclatures and coding systems for medical devices, and by designers of databases or information systems involving medical devices.