1、 STD-BSI DD ENV L;ZbLL-ENGL 1998 = Lb24bb9 0757bb5 758 DRAFT FOR DEVELOPMENT Medical informatics - Categorical structure of systems of concepts - Medical devices - DD ENV 1261 1:1998 IC$ 11.040,Ol; 35.240.70 n-= NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW u = STDsBSI DD EN
2、V 12bLL-ENGL 1998 W Lb24bb9 0757bbb by4 W Amd. No. DD ENV 12611:1998 Date Text affected National foreword This Draft for Development is the English language version of ENV 12611:1997. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series
3、 of publications 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 re
4、quested 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 initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of it
5、s threeyear life. The commencement of the review period wil 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
6、of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee ISTB5, Medical informatics, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the tex
7、t. A iist of organizations represented on this committee can be obtained on request to its secrem. 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 “intern
8、ational Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. This Draft for Development, having been prepared under the dircction of the DISC Board, was published undcr the authonty of the Standards Committee and comes into effect cm 15 November
9、 1998 O BSI 1998 Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 59 and a back cover. ISBN O 580 30535 X STD-BSI DD ENV L2bLL-ENGL 1998 D lb24bb9 0757bb7 520 m EUROPEAN PRESTANDARD PRNORME EUROPEENNE EUROPISCHE VORNORM ENV 12611 April 199
10、7 ICs 35.240.70 Descriptors: data processing, information interchange, medicine, medical devices English version Medical informatics - Categorial structure of systems of concepts - Medical Devices Infomtique de sant - Structure catgorielle de systmes de concepts - Dispositifs mdicaux Medizinische In
11、formatik - Kategoriale Struktur von Begriffssystmn - Medizinische Gerte * * u This European Prestandard (ENV) uas approved by CEN on 1997-03-11 as a prospective standard for provisional application. The period of validity of this ENV is limited initially to three years. After tuo years the members o
12、f CEN will be requested to submit their comnents, particularly on the question uhether the ENV can be converted into an European Standard (EN). CEN members are required to announce the existence of this ENV in the same uay as for an EN and to make the ENV available pranptly at national level in an a
13、ppropriate 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 bodies of Austria, Belgiun, Demrk, Finland, France, Germany, Gre
14、ece, Iceiand, Ireland, Italy, Luxembwrg, Netherlands, Norway, Portugal, Spain, Sweden, Suitzerland and United Kingdom. CEN European Cmittee for Standardization Comit Europen de Normalisation Europisches Komi tee f r Normng Central Secretariat: rue de Stassart,% 8-1050 Brussels 0 1997 CEN - All right
15、s of exploitation in any form and by any means reserved uoridwide for CEN national Members. Ref. No. ENV 12611:1997 E STDSBSI DD ENV L2bLL-ENGL 1998 Lb2qbbS 0757bbB 467 Page 2 ENV 12611 : 1997 Contents Foreword Introduction 0.1 Medical devices and medical device groups 0.2 Users and uses of nomencla
16、tures 0.3 Organizing medical device nomenclatures 0.4 Future applications 0.5 Relations to CEN/TC257/SC1 standards 0.6 Organization of this prestandard Normative references Definitions Target concepts Base concepts .- Semantic links and associated categories 6.1 Semantic links related to the intende
17、d purpose 6.2 Semantic links related to the intrinsic features 6.3 Additional semantic links 6.4 Generative pattern Combinatorial rules 7.1 Instance of a generative pattern 7.2 Nomenclature entries resulting from combination of elementary medical device groups Compliance Annex A. (Norm.) Base concep
18、ts, associated concepts and specific semantic links Annex B. (inform.) Systematic representation of (CENC257/SCl) medical device categories Annex C. (inform.) Complete systematic representation of the examples in the normative clauses Annex D. (inform.) Information on existing medical device nomencl
19、atures and coding systems Annex E. (inform.) Users and uses of medical device coding systems Annex F. (Inform.) Bibliography 3 3 3 4 5 6 7 7 a 8 8 11 11 12 12 14 14 15 16 16 16 16 19 31 33 37 53 59 - - STD-BSI DD ENV 12bLL-ENGL 1778 = Lb24bb9 0757bb9 3T3 Page 3 ENV 12611 : 1997 Foreword This Europea
20、n Prestandard has been prepared by Technical Committee CENTTC 251 Medical Informatics, the secretariat of which is held by IBN. According to the CENICENELEC Internal Regulations, the national standards organisations of the following countries are bound to announce this European Prestandard: Austria,
21、 Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzeriand and the United Kingdom. O Introduction 0.1 Metdical devices and medical device groups For the purpose of this prestandad medical devices are defined as
22、in the Medical Device Directive, 9314ZEEC. 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 variety of articles such as: electrocardiographs, ventilators, lasers, x-ray equipment, syringes, c
23、atheters, 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. Medical devices can be described at different levels of abstraction (shown in figure l), as do
24、ne in the pro- posed standard “prEN xxxx Nomenclature - Specification for a Nomenclature System for Medical Devices for the purpose of Regulatory Data Exchange“ from CENnC257/SCl. The lowest level of abstraction in the standard proposed by CENKC257/SCl is medical device type (3.12). This level only
25、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 xyz. There are more than 500 O00 different medical device types. The next level of abstraction
26、 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 w*ith similar functions. An example is “electrocardiograph“. There are up to 10 O00 different medical device groups. A medical device group is designate
27、d 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 co- vers many related medical device groups. An example is electro-medicalimechanical devices. A medical device group may belong to m
28、ore than one medical device category. There are in general 10 to 20 medical device categories. 12 medical device categories are defined in the standard proposed by CENTTC257/SCl (see annex B). Page 4 ENV 12611:1997 Number of concepts: Level of abstracon: Examples 10 - 20 10 O00 500 O00 medical devic
29、e ategory medical device group medical device type Electro-medical/ mechanical device Electrocardiograph Manufacturer ABCD model xyz Figure 1 Levels of abstraction for medical devices accordng to PEN xxxx from CEMC251/sCl. This prestandard is for the categorial structure of a system of concepts for
30、medical device groups. 0.2 Users and uses of nomenclatures Nomenclatures and coding systems for medical devices are used by several different parties (see annex E), among which are: - Clinical engineersitechnicians - Clinical personnel - Competent authoritiednotified bodies/accredited testhouses - F
31、inancing organkations/insurance companies - Health authorities - Hospital managers/administrators - Manufackirerrldistributorslservice vendors - Researchers. Each party has specific needs, and they may deal with medical devices at the different levels of abstraction described in O. 1. These parties
32、can be called “end users“ or “indirect users“. When nomenclatures for medical device groups are organized (see 0.3) by database designers and system developers, the organization must take into account the needs of the “end users“. This prestan- dard addresses the database designers and developers of
33、 nomenclatures, and thus these can be called “direct users“ of this prestandard. Summarizing, the users of this prestandard are: Direct users: Developers of nomenclatures, coding systems and designers of databases and information systems concerning medical devices. STD-BSI DD ENV L2bLL-ENGL 1998 Lb2
34、4bb9 0757b71 T5L Page 5 ENV 12611:1997 Indirect users: Users of medical devices and users of information systems dealing with medical device data. 0.3 Organizing medical device nomenclatures Existing nomenclatures (see annex D) for medical devices operate with up to 10 O00 medical device groups. (in
35、 different nomenclatures, different terms may be used for the term medical device group). There is no generally recognized way to organize these 10 O00 medical device groups and existing nomendatures imply different ways of organization, particularly concerning small subsets of medical device groups
36、, 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 to maintain a medical device group nomenclature and coding system, and it
37、 may be difficult to translate a medical device group nomenclature from one language to another. (See more about user needs in annex E). This prestandard defines a categorial structure for a system of concepts prENV 122641 for medical de- vice groups, .e. it outlines a system of descriptors in this
38、field and provides a generative pattern and combinatorial rules specifying how to combine the descriptors into sensible expressions. (References in refer to clause 2 or to annex F). Using a generative pattern, filled with appropriate descriptors, each medical device group may be precisely described
39、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 descriptors is the base concept (3.2), .e. a generic medical device that
40、 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 com- prehensive list of base concepts is given in annex A). One or more Characteristics differentiate a medical device gr
41、oup from its base concept; each cha- racteristic 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 illus- trated through the following example: Base concept (des
42、criptor): equipment Differentiating characteristic 1 : Semantic link: Descriptor: surgical field has context of use I Page 6 Differentiating characteristic 2: ENV 12611:1997 Semantic link: is based on Descriptor. laser technique (argon gas) This medical device group (target concept) is: Lasers, Surg
43、ical, Argon ref. 4, 164911 Examples of medical device groups with base concepts and differentiating characteristics are given in annex C. 0.4 Future applications If all medical device groups (of existing nomenclatures) are described with instances of generative pat- tems in a common way, a number of
44、 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 search possibilities. - Different structures of nomencl
45、atures 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 its se- mantic links and descriptors. lf this is do
46、ne according to common niles, 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 different medical device coding systems will be facili
47、tated. Every purpose requires a specific modification of the nomenclatures and of the classifications; national regulations and organizations require hirther modifications. The oniy way to ensure coherence among the different nomenclature systems is to map each (medical device group) terminological
48、phrase present in each nomenclature to a particular set of descriptors in a thesaurus (a system of descriptors), so that concepts considered as different (by the experts, in the nomenclature) are identified by a unique set of descriptors. In this way it is also possible to build a very large, compre
49、hensive, “master nomenclature, from which each application can extract its own subset of medical device groups to build a (new) nomenclature and coding system for a specific purpose. This “master nomenclature is solely for maintenance in a given Coding Centre, it is not for distribution to users. It may be used by National Coding Centres to produce their own nomenclatures; it may be used also by European Committees to produce their own nomenclatures. Each country will translate its appropriate selection of concepts; most concepts will have at least an Engl
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