1、November 2016 English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01.040.11; 01.040.35; 11.040.01
2、; 35.240.80!%u“2588296www.din.deDIN EN ISO 15225Medical devices Quality management Medical device nomenclature data structure (ISO 15225:2016);English version EN ISO 15225:2016,English translation of DIN EN ISO 15225:2016-11Medizinprodukte Qualittsmanagement Datenstruktur fr die Nomenklatur von Medi
3、zinprodukten (ISO 15225:2016);Englische Fassung EN ISO 15225:2016,Englische bersetzung von DIN EN ISO 15225:2016-11Dispositifs mdicaux Management de la qualit Structure des donnes de nomenclature des dispositifs mdicaux (ISO 15225:2016);Version anglaise EN ISO 15225:2016,Traduction anglaise de DIN E
4、N ISO 15225:2016-11SupersedesDIN EN ISO 15225:201010www.beuth.deDocument comprises 22 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.16 DIN EN ISO 15225:2016-11 2 A comma is used as the decimal marker. National foreword Thi
5、s document (EN ISO 15225:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medi
6、cal devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-13 AA Qualittsmanagement und entsprechende allgemeine Aspekte fr Medizinprodukte. The DIN Standards co
7、rresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 4135 DIN EN ISO 4135 ISO 9999 DIN EN ISO 9999 ISO/IEC 8859-1 DIN 66303 IEC 60601 (all parts) DIN EN 60601 (VDE 0750) (all parts) Amendments This standard differs from DIN EN ISO 15225
8、:2010-10 as follows: a) template terms have been removed as the hierarchy within the GMDN is now managed with the use of “collective terms”; b) “device category” has been removed as this provides no benefit for navigation, and its value has now been superseded by the use of “collective terms”; c) th
9、e prefix “preferred” has been removed from the term in the document and the word “term” now denotes the primary identifier for a generic device group of medical devices; d) “collective terms” can now be used by medical device regulators and other users to select larger groups of medical devices and
10、analyse larger sets of data. “Terms”, however, remain the only way to identify generic device groups of medical devices; e) “device type” data specification has been removed as it is outside the scope of the GMDN dataset, but remains a concept to which GMDN data are linked; f) the standard has been
11、editorially revised. Previous editions DIN EN ISO 15225: 2000-11, 2005-09, 2010-10 DIN EN ISO 15225:2016-11 3 National Annex NA (informative) Bibliography DIN 66303, Information technology 8 bit code DIN EN 60601 (VDE 0750) (all parts), Medical electrical equipment DIN EN ISO 1942, Dentistry Vocabul
12、ary DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 9999, Assistive products for persons with disability Classification and terminology DIN EN ISO 15225:2016-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15225 April 2016 I
13、CS 01.040.11; 01.040.35; 11.040.01; 35.240.80 Supersedes EN ISO 15225:2010 English version Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) Dispositifs mdicaux - Management de la qualit - Structure des donnes de nomenclature des dispositifs mdicaux (
14、ISO 15225:2016) Medizinprodukte - Qualittsmanagement - Datenstruktur fr die Nomenklatur von Medizinprodukten (ISO 15225:2016) This European Standard was approved by CEN on 9 June 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition
15、s for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standar
16、d exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELE
17、C members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo
18、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN
19、national Members and for CENELEC Members. Ref. No. EN ISO 15225:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Principle of structure 84.1 General . 84.2 Term . 94.2.1 Description 94.2.2 Term name 94.2.3 Term definition 94.2.4 Term code 94.2.5
20、 Links to relevant collective term(s) (see 4.3) . 94.2.6 Links to synonym(s) . 94.2.7 Links to multiple-linked synonym(s) . 94.3 Collective term . 104.4 Nomenclature structure example 104.5 Synonyms 104.6 Multiple-linked synonyms 104.7 Abbreviations and acronyms . 115 Data file dictionary 115.1 Gene
21、ral 115.2 Term data file . 115.3 Collective term data file 12Annex A (informative) Examples for generation of generic device group terms and synonyms 13Annex B (informative) Example of term record .15Annex C (informative) Examples of collective terms 16Annex D (informative) Examples of top-level col
22、lective term nodes .17Bibliography .18Contents PageDIN EN ISO 15225:2016-11 EN ISO 15225:2016 (E) 2Foreword .4European foreword This document (EN ISO 15225:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collabor
23、ation with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” 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 th
24、e latest by October 2016, and conflicting national standards shall be withdrawn at the latest by October 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or
25、 all such patent rights. This document supersedes EN ISO 15225:2010. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,
26、 Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice
27、 The text of ISO 15225:2016 has been approved by CEN as EN ISO 15225:2016 without any modification. 3DIN EN ISO 15225:2016-11 EN ISO 15225:2016 (E) ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of
28、 preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental
29、, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO
30、/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibilit
31、y that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of pate
32、nt declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as inform
33、ation about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices.This third edition
34、 of this International Standard based on experience gained from utilization of the second edition cancels and replaces the second edition (ISO 15225:2010), which has been technically revised. The following major changes have been made: Template terms have been removed as the hierarchy within the GMD
35、N is now managed with the use of collective terms. Device category has been removed as this provides no benefit for navigation and its value has now been superseded by the use of collective terms. The prefix preferred has been removed from term in the document and the word term now denotes the prima
36、ry identifier for generic device groups of medical devices. Collective terms can now be used by medical device regulators and other users to select larger groups of medical devices and analyse larger sets of data. Terms however remain the only way to identify generic device groups of medical devices
37、. Device type data specification has been removed as it is outside the scope of the GMDN dataset, but remains a concept to which GMDN data are linked.DIN EN ISO 15225:2016-11 EN ISO 15225:2016 (E) 4 IntroductionThis International Standard is intended to assist competent authorities, conformity asses
38、sment bodies, healthcare providers and manufacturers in the submission and exchange of information. It is intended that the information covered by this International Standard be available in the public domain.This third edition of this International Standard is based on experience gained from utiliz
39、ation of the second edition. The requirements contained in this International Standard are applicable to the development and updating of an international nomenclature and have been prepared specifically for construction of the Global Medical Device Nomenclature (GMDN).5DIN EN ISO 15225:2016-11 EN IS
40、O 15225:2016 (E) 1 ScopeThis International Standard specifies rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, ma
41、nufacturers, suppliers, healthcare providers and end users.This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.The requirements containe
42、d in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.This International Standard does not include the nomenclature itself, which is provided as a separate data file.2 Normative referencesThe following do
43、cuments, in whole or in part, are normatively referenced in the document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO/IEC 8859-1:1998, Info
44、rmation technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 13 Terms and definitionsFor the purposes of this document, the following terms and definitions apply1).3.1charactermember of a set of elements used for the organization, control or representation of dataSOUR
45、CE: ISO/IEC 8859-1:1998, 4.33.2codesystem of alpha, alphanumeric or numeric characters and rules by which information is represented, communicated, or both3.3collective termterm provides a multi-hierarchical structure to search for appropriate generic device group terms by using broad common feature
46、s or characteristics1) In this International Standard, many terms are used which have their basis in regulatory statutes, e.g. “medical device”, “custom made medical device” and “manufacturer”. These terms are defined in the respective jurisdictions where the nomenclature is used.DIN EN ISO 15225:20
47、16-11 EN ISO 15225:2016 (E) 6 3.4conceptunit of knowledge created by a unique combination of characteristicsSOURCE: ISO 1087-1:2000, 3.2.1, modified Note 1 to entry has been deleted.3.5definitionformal concise statement of the meaning of a term3.6device intended for clinical investigationdevice inte
48、nded for use in a designed and planned systematic study in or on human subjects to verify safety, performance, or both3.7device intended for performance evaluationdevice intended by the manufacturer to be subject to performance evaluation studies in laboratories for medical analyses or other appropriate environments3.8device typeidentification of a manufacturers specific kind of products, i.e., for similar usage or series of comparable modelsNote 1 to entry: This data element is not included in the GMDN nomenclature, but is coded in various ways outside of the nomenclature a
