1、DRAFT FOR DEVELOPMENT DD ENV 12611:1998 Medical informatics Categorical structure of systems of concepts Medical devices ICS 11.040.01; 35.240.70DDENV12611:1998 This Draft for Development, having been prepared under thedirection of the DISC Board, was published under the authorityof the Standards Co
2、mmittee and comes into effect on 15 November 1998 BSI 05-1999 ISBN 0 580 30535 X National foreword This Draft for Development is the English language version of ENV12611:1997. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publ
3、ications and is of a provisional nature due to the limited duration of the European prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested
4、so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated2years after its publication by the European organization so that a decision can be taken on its status at the end of its three-ye
5、ar life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the p
6、restandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Medical informatics, at389 Chiswick High Road, LondonW44AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list
7、of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International
8、 Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theENV title page, pages 2 to 42 and a back cover. This standard has been updated (see copyright
9、 date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsDDENV12611:1998 BSI 05-1999 i Contents Page National foreword Inside front cover Foreword 2 Text of ENV 12611 3ii blankE
10、UROPEAN PRESTANDARD PRNORME EUROPENNE EUROPISCHE VORNORM ENV 12611 April 1997 ICS 35.240.70 Descriptors: Data processing, information interchange, medicine, medical devices English version Medical informatics Categorial structure of systems of concepts Medical Devices Informatique de sant Structure
11、catgorielle de systmes de concepts Dispositifs mdicaux Medizinische Informatik Kategoriale Struktur von Begriffssystemen Medizinische Gerte This European Prestandard (ENV) was approved by CEN on1997-03-11 as a prospective standard for provisional application. The period of validity of this ENV is li
12、mited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the ENV can be converted into an European Standard (EN). CEN members are required to announce the existance of this ENV in the same way as for an EN and
13、 to make the ENV available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reached. CEN members are the national standards bod
14、ies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secr
15、etariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. ENV 12611:1997 EENV12611:1997 BSI 05-1999 2 Foreword This European Prestandard has been prepared by Technical Committee CEN/TC251 “Medic
16、al Informatics”, the secretariat of which is held by IBN. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to announce this European Prestandard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
17、 Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 0 Introduction 3 0.1 Medical devices and medical device groups 3 0.2 Users and uses of nomenclatures 3 0.3 Organizing medical device nomenclatures 4 0.4 Future applications
18、5 0.5 Relations to CEN/TC257/SC1 standards 5 0.6 Organization of this prestandard 5 1 Scope 5 2 Normative references 6 3 Definitions 6 4 Target concepts 8 5 Base concepts 8 6 Semantic links and associated categories 8 6.1 Semantic links related to the intended purpose 9 6.2 Semantic links related to
19、 the intrinsic features 10 6.3 Additional semantic links 11 6.4 Generative pattern 11 7 Combinatorial rules 12 7.1 Instance of a generative pattern 12 7.2 Nomenclature entries resulting from combination of elementary medical device groups 12 8 Compliance 12 Annex A (normative) Base concepts, associa
20、ted concepts and specific semantic links 13 Annex B (informative) Systematic representation of (CEN/TC257/SC1) medical device categories 22 Page Annex C (informative) Complete systematic representation of the examples in the normative clauses 23 Annex D (informative) Information on existing medical
21、device nomenclatures and coding systems 26 Annex E (informative) Users and uses of medical device coding systems 38 Annex F (informative) Bibliography 41 Figure 1 Levels of abstraction for medical devices according to prEN xxxx from CEN/TC251/SC1 3 Table 6.1 Summary of semantic links and associated
22、categories 11 Table A1.1 Non-exhaustive list of very generic base concepts 14 Table A1.2 Non-exhaustive list of base concepts identified by an explicit systematic representation 14 Table A1.3 Non-exhaustive list of base concepts not suitable for complete systematic representation 16 Table A2.1 Non-e
23、xhaustive list of associated concepts, organized according to the associated categories used by semantic links described in6.1 and6.2 17 Table A2.2 Non-exhaustive list of associated concepts belonging to the associated categories: , , 20 Table A2.3 Non-exhaustive list of associated concepts, organiz
24、ed according to the associated categories used by semantic links described in6.3 21 Table A3.1 List of specific semantic links related to particular associated categories, allowed to replace “has specification:” within a narrow subfield 22ENV12611:1997 BSI 05-1999 3 0 Introduction 0.1 Medical device
25、s and medical device groups For the purpose of this prestandard medical devices are defined as in the Medical Device Directive,93/42/EEC. They include almost any article apart from medicinal products which are used on human beings for medical purposes. Thus medical devices comprise a very large vari
26、ety of articles such as: electrocardiographs, ventilators, lasers, x-ray equipment, syringes, catheters, dental materials and hearing aids. The millions of actual physical medical device items in use around the world are not considered in this standard; only medical device groups as explained below.
27、 Medical devices can be described at different levels of abstraction (shown inFigure 1), as done in the proposed standard “prEN xxxx Nomenclature Specification for a Nomenclature System for Medical Devices for the purpose of Regulatory Data Exchange” from CEN/TC257/SC1. The lowest level of abstracti
28、on in the standard proposed by CEN/TC257/SC1 is medical device type (3.12). This level only covers one particular kind of medical device produced by a given manufacturer and with a particular identification assigned by the manufacturer. An example is an electrocardiograph from company ABCD, model xy
29、z. There are more than500000 different medical device types. The next level of abstraction is medical device group (3.10). This level ranges from medical device type to medical device category, and it covers a set of medical device types with similar functions. An example is “electrocardiograph”. Th
30、ere are up to10000 different medical device groups. A medical device group is designated by a term, or more frequently by a terminological phrase (3.18). The highest level of abstraction is the medical device category (3.9). Each medical device category covers many related medical device groups. An
31、example is electro-medical/mechanical devices. A medical device group may belong to more than one medical device category. There are in general10 to20 medical device categories.12 medical device categories are defined in the standard proposed by CEN/TC257/SC1 (seeAnnex B). This prestandard is for th
32、e categorial structure of a system of concepts for medical device groups. 0.2 Users and uses of nomenclatures Nomenclatures and coding systems for medical devices are used by several different parties (seeAnnex E), among which are: Clinical engineers/technicians Clinical personnel Competent authorit
33、ies/notified bodies/accredited testhouses Financing organizations/insurance companies Figure 1 Levels of abstraction for medical devices according to prEN xxxx from CEN/TC251/SC1ENV12611:1997 4 BSI 05-1999 Health authorities Hospital managers/administrators Manufacturers/distributors/service vendors
34、 Researchers. Each party has specific needs, and they may deal with medical devices at the different levels of abstraction described in0.1. These parties can be called “end users” or “indirect users”. When nomenclatures for medical device groups are organized (see0.3) by database designers and syste
35、m developers, the organization must take into account the needs of the “end users”. This prestandard addresses the database designers and developers of nomenclatures, and thus these can be called “direct users” of this prestandard. Summarizing, the users of this prestandard are: Direct users: Develo
36、pers of nomenclatures, coding systems and designers of databases and information systems concerning medical devices. Indirect users: Users of medical devices and users of information systems dealing with medical device data. 0.3 Organizing medical device nomenclatures Existing nomenclatures (seeAnne
37、x D) for medical devices operate with up to10000 medical device groups. (In different nomenclatures, different terms may be used for the term medical device group). There is no generally recognized way to organize these10000 medical device groups and existing nomenclatures imply different ways of or
38、ganization, particularly concerning small subsets of medical device groups, selected for special uses. The lack of strong organization can cause problems for users. It may, for instance, be difficult to find the relevant medical device group when registering a new medical device. It may be difficult
39、 to maintain a medical device group nomenclature and coding system, and it may be difficult to translate a medical device group nomenclature from one language to another. (See more about user needs inAnnex E). This prestandard defines a categorial structure for a system of concepts prENV12264 for me
40、dical device groups, i.e. it outlines a system of descriptors in this field and provides a generative pattern and combinatorial rules specifying how to combine the descriptors into sensible expressions. (References in refer to clause2 or toAnnex F). Using a generative pattern, filled with appropriat
41、e descriptors, each medical device group may be precisely described within the system of concepts; this instance of generative pattern may be used to generate systematic names or to uniquely identify each medical device group with respect to the others. For each medical device group, one of the desc
42、riptors is the base concept (3.2), i.e. a generic medical device that may be used as superordinate concept to produce a systematic intensional definition. Examples of base concepts are: microscope, pacemaker, syringe, catheter and bandage. (A more comprehensive list of base concepts is given inAnnex
43、 A). One or more characteristics differentiate a medical device group from its base concept; each characteristic is made up of a semantic link (3.14) followed by a descriptor associated concept (3.1). The semantic link can be considered as a question with the descriptor providing the answer. This is
44、 illustrated through the following example: Base concept (descriptor): equipment Differentiating characteristic1: Differentiating characteristic2: Semantic link: has context of use Descriptor: surgical field Semantic link: is based on Descriptor: laser technique (argon gas) This medical device group
45、 (target concept) is: Lasers, Surgical, Argon ref.4,16-491ENV12611:1997 BSI 05-1999 5 Examples of medical device groups with base concepts and differentiating characteristics are given inAnnex C. 0.4 Future applications If all medical device groups (of existing nomenclatures) are described with inst
46、ances of generative patterns in a common way, a number of possibilities would be available to the user. Among these are: A structured and precise “description” of each medical device group facilitating understanding (and translation to other languages). The descriptors will permit a large number of
47、search possibilities. Different structures of nomenclatures for medical device groups needed for different purposes can be dynamically explored by sorting on patterns of semantic links or descriptors. A new device group is “easily placed in the nomenclature” in a structured way, if it first is given
48、 its semantic links and descriptors, if this is done according to common rules, all new device groups will be identified in the same way in all existing nomenclatures for medical devices, and thus the differences between the existing nomenclatures will be diminished in future. Mapping between differ
49、ent medical device coding systems will be facilitated. Every purpose requires a specific modification of the nomenclatures and of the classifications; national regulations and organizations require further modifications. The only way to ensure coherence among the different nomenclature systems is to map each (medical device group) terminological phrase present in each nomenclature to a particular set of descriptors in a thesaurus (a system of descriptors), so that concepts considered as di
