1、September 2006DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 13DIN Deutsches Institut fr Normung e.V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e.V., Berlin, gestattet.ICS 35.240.80!,k#x“9720085www.din.deDDIN EN 1068Me
2、dizinische Informatik Registrierung von Kodierungsschemata;Englische Fassung EN 1068:2005Health informatics Registration of coding systems;English version EN 1068:2005Informatique de sant Enregistrement des systmes de codage;Version anglaise EN 1068:2005Alleinverkauf der Normen durch Beuth Verlag Gm
3、bH, 10772 BerlinErsatz frDIN V ENV 1068:1994-02www.beuth.deGesamtumfang 24 SeitenDIN EN 1068:2006-09 2 Nationales Vorwort Diese Norm enthlt unter Bercksichtigung des Prsidialbeschlusses 13/1983 den englischen Originaltext der Europischen Norm EN 1068, Ausgabe 2005-06. Die Europische Norm wurde in de
4、r WG 3 Security, safety and quality des CEN/TC 251 Medizinische Informatik, dessen Sekretariat vom NEN (Niederlande) gehalten wird, erarbeitet. Der NA 063-07-03 AA Terminologie des Fachbereichs 7 Medizinische Informatik des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. Diese Eu
5、ropische Norm legt ein Verfahren zur Registrierung von Kodierungsschemata (Kodierungs-systemen) fr alle Zwecke im Gesundheitswesen fest. Sie legt ebenso eindeutige Bezeichner fr Kodierungsschemata im Gesundheitswesen (HCD: Health Coding System Designator) fr jedes registrierte Kodierungsschemata fes
6、t. Erst durch die Verbindung mit einem HCD kann einem Kode eine eindeutige Bedeutung zugeordnet werden. Das Verfahren, wodurch ein HCD einem Kode zugeordnet wird, wird nicht durch diese Europische Norm festgelegt. Die Zuordnung wird erreicht durch eine geeignete, anderweitig festzulegende Syntax. Di
7、ese Europische Norm legt nicht fest, welche Kodierungsschemata im Gesundheitswesen zu verwenden sind, gibt keine Anleitung fr ihre Auswahl und beschreibt auch nicht die Verfahren, wie Informationen in kodierter Form abgebildet werden. Auch die Kombination verschiedener Kodierungsschemata, die von ve
8、rschiedenen verantwortlichen Organisationen gepflegt werden, gehrt nicht zum Anwendungsbereichs der vorliegenden Norm. nderungen Gegenber DIN V ENV 1068:1994-02 wurden folgende nderungen vorgenommen: a) der Vornormcharakter wurde aufgehoben; b) der Inhalt wurde im Aufbau und technisch berarbeitet. F
9、rhere Ausgaben DIN V ENV 1068: 1994-02 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1068 June 2005 ICS 11.020; 35.240.01 Supersedes ENV 1068:1993 English version Health informatics - Registration of coding systems Informatique de sant - Enregistrement des systmes de codage Medizinische Infor
10、matik - Registrierung von Kodierungsschemata This European Standard was approved by CEN on 17 April 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteratio
11、n. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translatio
12、n under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungar
13、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de S
14、tassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1068:2005: EEN 1068:2005 (E) 2 Contents Page Foreword 3 Introduction4 1 Scope .5 2 Normative References 5 3 Terms, definitions and abbreviations5 4 Id
15、entification of health coding systems 8 5 User agreements.9 6 The Registration Authority.9 7 The Register of Health Coding Systems .9 8 Submitting Organisations 11 9 Responsible Organisations12 10 Disputes.14 Annex A (normative) Specification of the Health Coding System Designator.15 Annex B (inform
16、ative) Illustration of terms used in this document16 Annex C (informative) Multiple registrations of health coding systems 17 Annex D (informative) Version control and changes to coding systems.19 Bibliography.21 Alphabetical Index .22 EN 1068:2005 (E) 3 Foreword This European Standard (EN 1068:2005
17、) has been prepared by Technical Committee CEN /TC 251, “ Health Informatics“, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2005, and conflicti
18、ng national standards shall be withdrawn at the latest by December 2005. This European Standard supersedes ENV 1068:1993. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium
19、, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 1068:2005 (E) 4 Introduction The increase
20、d use of data processing and telecommunications capabilities has made possible the interchange of information in machine readable and machine processable formats. As automated interchange of information in health increases it is essential to provide the appropriate information interchange standards.
21、 Representation of information in coded form facilitates its processing by computer and enables it to be expressed with a precision and independence from language that may be difficult to achieve in other forms. Coded representation is therefore frequently used in information interchange for all typ
22、es of application. There are many coding systems in use in health. In the development of this European Standard it was recognised that immediate international adoption of a single coding system for each type of health information is impracticable. Therefore, when interchanging information, it is nec
23、essary to identify unambiguously the coding systems used for its representation. This European Standard recognises existing coding systems and provides a means for using them in a uniform way in health information interchange. It allows an occurrence of health information to be represented by more t
24、han one coding system. However the registration procedure is also intended to discourage the unnecessary proliferation of coding systems used for the interchange of health information. The use of the procedures in this European Standard will: a) facilitate the representation of health information in
25、 coded form for all purposes; b) reduce the potential ambiguity of information in coded form; c) reduce the need for human intervention in information interchange between applications; d) diminish the time required for the introduction of information interchange agreements; e) provide independence f
26、rom language; f) in consequence of the foregoing, reduce the cost of information interchange. It has been produced by the European Body because, to date, there has been no successful implementation of an International Standard addressing the same needs, while it is urgently required to facilitate in
27、formation interchange in health within Europe. It is nevertheless recognised that the subject is a matter for world-wide co-operation. This European Standard has therefore been written in conformance with the ISO/IEC Directives and every attempt has been made to avoid introducing regional bias. In t
28、he situation resulting from the instatement of ISO/IEC 11179-6, this European Standard should be considered as providing a mean for a sectorial for health , and regional at least for Europe implementation of the International Standard. As a consequence, the Registration Authority meant by this Europ
29、ean Standard should eventually refer to the Central Registration Authority planned in the International Standard. As per this European Standard, a comprehensive international register of health coding systems will be created and will be made available to all those who may benefit from the informatio
30、n it contains. It might also occur that organisations outside Europe submit health coding systems for registration in accordance with it. The role to be played by the Registration Authority as per this European Standard, (referred to in Clause 6, and elsewhere in this European Standard), and its bas
31、ic rules of procedure, are the subject for a separate supporting document (“Health Informatics Health Information Interchange Registration of Coding Systems The Registration Authority“). EN 1068:2005 (E) 5 1 Scope This European Standard specifies a procedure for the registration of coding systems us
32、ed in health for any purpose. It also specifies the allocation of a unique Health Coding System Designator to each registered coding system. A code value can thus be given an unambiguous meaning by association with a HCD. The method by which a HCD and a code value are associated is not defined by th
33、is European Standard. The association is achieved in any manner appropriate to the syntax used. This European Standard does not specify the coding systems to be used in health, give guidance on their selection nor describe methods of representing information in coded form. Coding systems maintained
34、by different Responsible Organisations may also be used in combinations. Such combinations can be considered as templates, and as such they lie outside the scope of the current document. 2 Normative References The following referenced documents are indispensable for the application of this document.
35、 For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 6523-1:1999 Information technology - Structure for the identification of organizations and organization parts ISO/IEC 11179-6:2005
36、Information Technology Metadata registries (MDR) Part 6: Registration3 Terms, definitions and abbreviations For the purposes of this European Standard, the following terms and definitions apply: 3.1 bit; binary digit either of the digits 0 or 1 when used in the pure binary numeration system ISO/IEC
37、2382-4:1999 3.2 character member of a set of elements that is used for the representation, organisation or control of data ISO/IEC 2382-4:1999 EN 1068:2005 (E) 6 3.3 character set finite set of different characters that is complete for a given purpose ISO/IEC 2382-4:1999 3.4 coded set set of element
38、s which is mapped on to another set according to a coding scheme ISO/IEC 2382-4:1999 3.5 code meaning element within a coded set EXAMPLE: “Paris Charles-De-Gaulle“ which is mapped on to the three-letter abbreviation “CDG“ by the coding system for three-letter abbreviations of airport names. 3.6 code
39、 value result of applying a coding scheme to a code meaning EXAMPLE: “CDG“ as the representation of “Paris Charles-De-Gaulle“ in the coding system for three-letter representations of airport names. (based on ISO 2382-4, modified to use preferred terms defined above: coding system for code and code m
40、eaning for an element of a coded set.) NOTE 1 The definition provided by ISO 2382-4:1999 is modified in order to use the preferred (synonymous) terms coding scheme (instead of the deprecated code), and code NOTE 2 A diagrammatic illustration of the terms defined in 3.4, 3.5, 3.6 and 3.8 is provided
41、in annex B. 3.7 coding scheme collection of rules that maps the elements of one set on to the elements of a second set ISO/IEC 2382-4:1999 NOTE NOTE: The two sets considered here are (1) a set of code meanings (or coded set), and (2) a set of code values (or code set). 3.8 coding system combination
42、of a set of code meanings and a set of code values, based on a coding scheme 3.9 data element unit of data for which the definition, identification, representation, and permissible values are specified by means of a set of attributes ISO/IEC 11179-6:2005 3.10 Data Identifier (DI) identifier assigned
43、 to a data within a Registration Authority ISO/IEC 11179-6:2005 3.11 health coding system coding system used in health EN 1068:2005 (E) 7 NOTE According to ISO/IEC 11179, a health coding System is a data element. 3.12 Health Coding System Designator HCD unique permanent identifier of a health coding
44、 system registered for use in information interchange under the terms of this document NOTE A formal specification of the health coding system designator is included in Annex A. 3.13 health coding system specification source of information about a health coding system maintained and made available b
45、y the Responsible Organisation in accordance with the terms of this document 3.14 International Registration Data Identifier internationally unique identifier for a data element ISO/IEC 11179-6:2005 3.15 organisation unique framework of authority within which a person or persons act, or are designat
46、ed to act, towards some purpose ISO/IEC 6523-1:1999 NOTE Groupings and subdivisions of an organisation may also be considered as organisations where there is a need to identify these in information interchange. 3.16 Register of Health Coding Systems register that is maintained in accordance with the
47、 provisions of this document 3.17 Registration Authority (for health coding systems) organisation responsible for assigning Health Coding System Designators and for maintaining the Register of Health Coding Systems as described in this document Organisation authorised to register data elements ISO/I
48、EC 11179-6:2005 3.18 Registration Authority Identifier identifier assigned to a Registration Authority ISO/IEC 11179-6:2005 3.19 Responsible Organisation (of a health coding scheme) organisation which assumes responsibility for the administration of a specific health coding scheme. Organisation or u
49、nit within an organisation that is responsible for the contents of the mandatory attributes by which a data element is specified ISO/IEC 11179-6:2005 3.20 Submitting Organisation (for health coding systems) organisation recognised by the requirements of this document to receive requests for registration of health coding systems from Responsible Organisations and submit them to the Registration Authority. EN 1068:2005 (E) 8 Organisation or unit within an organisation that has submitted the da
