SIST EN ISO 15225:2016
(Main)Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
This 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, manufacturers, 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 contained 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.
Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von Medizinprodukten (ISO 15225:2016)
Diese Internationale Norm legt Regeln fest und enthält Richtlinien für eine Datenstruktur für die Nomenklatur von Medizinprodukten, um die Zusammenarbeit und den Austausch von behördlich relevanten Daten auf internationaler Ebene zwischen den betreffenden Stellen, wie Behörden, Hersteller, Lieferanten, Einrichtungen der Gesundheitsversorgung und Endanwendern zu erleichtern.
Diese Internationale Norm enthält Anleitungen für einen Mindestdatensatz und dessen Struktur. Diese Anleitungen sind für Systemplaner vorgesehen, die Datenbanken unter Verwendung des hierin beschriebenen Nomenklatursystems aufbauen.
Die in dieser Internationalen Norm enthaltenen Anforderungen gelten für die Entwicklung und Pflege einer internationalen Nomenklatur zur Identifikation von Medizinprodukten.
Diese Internationale Norm enthält nicht die eigentliche Nomenklatur, die als getrennte Datei bereitgestellt wird.
Dispositifs médicaux - Management de la qualité - Structure des données de nomenclature des dispositifs médicaux(ISO 15225:2016)
L'ISO 15225:2016 spécifie des règles et des lignes directrices de structuration des données d'une nomenclature des dispositifs médicaux, afin de faciliter la coopération et l'échange des données utilisées par les autorités réglementaires sur un plan international entre les parties intéressées, par exemple autorités de régulation, fabricants, fournisseurs, professionnels de santé et utilisateurs finaux.
L'ISO 15225:2016 comprend des lignes directrices pour un ensemble de données minimal et sa structure. Ces lignes directrices sont prévues pour les concepteurs de système qui établissent des bases de données utilisant le système de nomenclature décrit ci-après.
Les exigences contenues dans l'ISO 15225:2016 sont applicables à la création et à la maintenance d'une nomenclature internationale destinée à l'identification des dispositifs médicaux.
L'ISO 15225:2016 n'inclut pas la nomenclature en elle-même, qui est fournie sous forme de fichier de données séparé.
Medicinski pripomočki - Vodenje kakovosti - Struktura podatkov za poimenovanje medicinskih pripomočkov (ISO 15225:2016)
Ta mednarodni standard določa pravila in smernice za strukturo podatkov za poimenovanje medicinskih pripomočkov z namenom olajšati sodelovanje in izmenjavo podatkov, ki jih uporabljajo regulativni organi na mednarodni ravni, med zainteresiranimi stranmi, kot so regulativni organi, proizvajalci, dobavitelji,
ponudniki zdravstvenih storitev in končni uporabniki.
Ta mednarodni standard vključuje smernice za minimalni podatkovni sklop in njegovo strukturo. Smernice so namenjene načrtovalcem sistemov pri vzpostavljanju zbirk podatkov, ki uporabljajo tukaj opisan sistem poimenovanja.
Zahteve v tem mednarodnem standardu se uporabljajo za razvoj in vzdrževanje mednarodnega poimenovanja za identifikacijo medicinskih pripomočkov.
Ta mednarodni standard ne vključuje dejanskega poimenovanja; to je na voljo kot ločena podatkovna datoteka.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15225:2016
01-junij-2016
1DGRPHãþD
SIST EN ISO 15225:2010
0HGLFLQVNLSULSRPRþNL9RGHQMHNDNRYRVWL6WUXNWXUDSRGDWNRY]DSRLPHQRYDQMH
PHGLFLQVNLKSULSRPRþNRY ,62
Medical devices - Quality management - Medical device nomenclature data structure
(ISO 15225:2016)
Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von
Medizinprodukten (ISO 15225:2016)
Dispositifs médicaux - Management de la qualité - Structure des données de
nomenclature des dispositifs médicaux(ISO 15225:2016)
Ta slovenski standard je istoveten z: EN ISO 15225:2016
ICS:
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 15225:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15225:2016
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SIST EN ISO 15225:2016
EUROPEAN STANDARD
EN ISO 15225
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2016
ICS 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 médicaux - Management de la qualité - Medizinprodukte - Qualitätsmanagement -
Structure des données de nomenclature des dispositifs Datenstruktur für die Nomenklatur von
médicaux(ISO 15225:2016) 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 conditions 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 Standard 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 CENELEC 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, Luxembourg, 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 Ref. No. EN ISO 15225:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 15225:2016
EN ISO 15225:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 15225:2016
EN ISO 15225:2016 (E)
European 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 collaboration 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 the 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 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, 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
The text of ISO 15225:2016 has been approved by CEN as EN ISO 15225:2016 without any modification.
3
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SIST EN ISO 15225:2016
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SIST EN ISO 15225:2016
INTERNATIONAL ISO
STANDARD 15225
Third edition
2016-03-15
Medical devices — Quality
management — Medical device
nomenclature data structure
Dispositifs médicaux — Management de la qualité — Structure des
données de nomenclature des dispositifs médicaux
Reference number
ISO 15225:2016(E)
©
ISO 2016
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SIST EN ISO 15225:2016
ISO 15225:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 15225:2016
ISO 15225:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle of structure . 3
4.1 General . 3
4.2 Term . 4
4.2.1 Description . . . 4
4.2.2 Term name . 4
4.2.3 Term definition . 4
4.2.4 Term code . 4
4.2.5 Links to relevant collective term(s) (see 4.3) . 4
4.2.6 Links to synonym(s) . 4
4.2.7 Links to multiple-linked synonym(s) . 4
4.3 Collective term . 5
4.4 Nomenclature structure example . 5
4.5 Synonyms . 5
4.6 Multiple-linked synonyms. 5
4.7 Abbreviations and acronyms . 6
5 Data file dictionary . 6
5.1 General . 6
5.2 Term data file . . 6
5.3 Collective term data file . 7
Annex A (informative) Examples for generation of generic device group terms and synonyms .8
Annex B (informative) Example of term record .10
Annex C (informative) Examples of collective terms .11
Annex D (informative) Examples of top-level collective term nodes .12
Bibliography .13
© ISO 2016 – All rights reserved iii
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SIST EN ISO 15225:2016
ISO 15225:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of 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, 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/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 possibility 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 patent 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 information about ISO’s 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 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 GMDN 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 primary 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.
— ‘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.
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SIST EN ISO 15225:2016
ISO 15225:2016(E)
Introduction
This International Standard is intended to assist competent authorities, conformity assessment 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 utilization 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).
© ISO 2016 – All rights reserved v
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SIST EN ISO 15225:2016
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SIST EN ISO 15225:2016
INTERNATIONAL STANDARD ISO 15225:2016(E)
Medical devices — Quality management — Medical device
nomenclature data structure
1 Scope
This 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, manufacturers, 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 contained 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 references
The following documents, 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, Information technology — 8-bit single-byte coded graphic character sets — Part 1:
Latin alphabet No. 1
3 Terms and definitions
1)
For the purposes of this document, the following terms and definitions apply .
3.1
character
member of a set of elements used for the organization, control or representation of data
[SOURCE: ISO/IEC 8859-1:1998, 4.3]
3.2
code
system of alpha, alphanumeric or numeric characters and rules by which information is represented,
communicated, or both
3.3
collective term
term provides a multi-hierarchical structure to search for appropriate generic device group terms by
using broad common features or characteristics
1) 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.
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SIST EN ISO 15225:2016
ISO 15225:2016(E)
3.4
concept
unit of knowledge created by a unique com
...
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