EN ISO 15225:2010
(Main)Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
ISO 15225:2010 provides 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, health care providers and end users.
ISO 15225:2010 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 ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.
ISO 15225:2010 does not include the nomenclature itself, which is provided as a data file.
Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von Medizinprodukten (ISO 15225:2010)
von Medizinprodukten, um die Zusammenarbeit und den Austausch von behördlich relevanten Daten auf
internationaler Ebene zwischen den betreffenden Stellen, wie Behörden, Hersteller, Lieferanten, Gesundheitsfürsorgeeinrichtungen
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 Norm enthaltenen Anforderungen gelten für die Entwicklung und Pflege einer internationalen
Nomenklatur zur Identifikation von Medizinprodukten.
Die vorliegende Internationale Norm enthält nicht die eigentliche Nomenklatur, die als Datei bereitgestellt wird.
Dispositifs médicaux - Management de la qualité - Structure des données de nomenclature des dispositifs médicaux (ISO 15225:2010)
L'ISO 15225:2010 propose 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 15225:2010 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 15225:2010 sont applicables à la création et à la maintenance d'une nomenclature internationale pour l'identification des dispositifs médicaux.
L'ISO 15225:2010 n'inclut pas la nomenclature en elle-même, qui est fournie sous forme d'un fichier de données.
Medicinski pripomočki - Vodenje kakovosti - Struktura podatkov za poimenovanje medicinskih pripomočkov (ISO 15225:2010)
Ta mednarodni standard zagotavlja pravila in smernice za strukturo podatkov za poimenovanje medicinskih pripomočkov, ki omogočajo sodelovanje in izmenjavo podatkov, ki jih uporabljajo regulativni organi na mednarodni ravni, med zainteresiranimi stranmi, npr. regulativnimi organi, proizvajalci, dobavitelji, izvajalci zdravstvenih storitev in končnimi uporabniki. Ta mednarodni standard vključuje smernice za minimalni nabor podatkov in njegovo strukturo. Te smernice so namenjene načrtovalcem sistema, ki vzpostavljajo podatkovne baze, ki uporabljajo tukaj opisani sistem poimenovanja. Zahteve, ki jih vsebuje ta mednarodni standard, veljajo za razvoj in vzdrževanje mednarodnega poimenovanja za identifikacijo medicinskih pripomočkov.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2010
1DGRPHãþD
SIST EN ISO 15225:2000
SIST EN ISO 15225:2000/A1:2004
SIST EN ISO 15225:2000/A2:2005
0HGLFLQVNLSULSRPRþNL9RGHQMHNDNRYRVWL6WUXNWXUDSRGDWNRY]DSRLPHQRYDQMH
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Medical devices - Quality management - Medical device nomenclature data structure
(ISO 15225:2010)
Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von
Medizinprodukten (ISO 15225:2010)
Dispositifs médicaux - Management de la qualité - Structure des données de
nomenclature des dispositifs médicaux (ISO 15225:2010)
Ta slovenski standard je istoveten z: EN ISO 15225:2010
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15225
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2010
ICS 11.040.01; 35.240.80 Supersedes EN ISO 15225:2000
English version
Medical devices - Quality management - Medical device
nomenclature data structure (ISO 15225:2010)
Dispositifs médicaux - Management de la qualité - Medizinprodukte - Qualitätsmanagement - Datenstruktur für
Structure des données de nomenclature des dispositifs die Nomenklatur von Medizinprodukten (ISO 15225:2010)
médicaux (ISO 15225:2010)
This European Standard was approved by CEN on 27 February 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15225:2010 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 15225:2010) 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 November 2010, and conflicting national standards shall be withdrawn
at the latest by November 2010.
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 15225:2000.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15225:2010 has been approved by CEN as a EN ISO 15225:2010 without any modification.
INTERNATIONAL ISO
STANDARD 15225
Second edition
2010-05-01
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 15225:2010(E)
©
ISO 2010
ISO 15225:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 15225:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Principle of structure .4
4.1 General .4
4.2 Device category .5
4.3 Collective term.5
4.4 Generic device group.5
4.5 Device type.6
4.6 Nomenclature structure example .6
5 Requirements.7
5.1 Device category .7
5.2 Generic device group.7
5.3 Device type.9
5.4 Collective term.9
6 Data file dictionary .9
6.1 General .9
6.2 Device category data file .9
6.3 Generic device group data file .9
6.4 Device type data file .10
6.5 Collective term data file .11
Annex A (informative) Device categories .12
Annex B (informative) Examples for generation of generic device group terms and synonyms.15
Annex C (informative) Examples of generic device group records.18
Annex D (informative) Examples of collective terms .19
Bibliography.20
ISO 15225:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15225 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This second edition cancels and replaces the first edition (ISO 15225:2000), which has been technically
revised. It also incorporates the Amendment ISO 15225:2000/Amd.1:2004.
iv © ISO 2010 – All rights reserved
ISO 15225:2010(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 second edition of this International Standard is based on experience gained from utilization of the first
edition. The following major changes have been made to the first edition:
⎯ definitions have been added in Clause 3 for base concept, collective term, device category, device type,
generic device group, Global Medical Device Nomenclature (GMDN), GMDN agency, multiple-linked
synonym, product specifier and template specifier;
⎯ Codes 13, 14 and 15 have been added in Annex A, and the descriptions have been updated with
examples of new technologies;
⎯ Annex D has been added containing examples of collective terms.
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).
INTERNATIONAL STANDARD ISO 15225:2010(E)
Medical devices — Quality management — Medical device
nomenclature data structure
1 Scope
This International Standard provides rules and guidelin
...
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