SIST 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)
This International Standard 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. 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.
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.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15225:2010
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
PHGLFLQVNLKSULSRPRþNRY ,62
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
SIST EN ISO 15225:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15225:2010
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SIST EN ISO 15225:2010
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.
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SIST EN ISO 15225:2010
EN ISO 15225:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 15225:2010
EN ISO 15225:2010 (E)
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.
3
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SIST EN ISO 15225:2010
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SIST EN ISO 15225:2010
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
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SIST EN ISO 15225:2010
ISO 15225:2010(E)
PDF disclaimer
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland
ii © ISO 2010 – All rights reserved
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SIST EN ISO 15225:2010
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 2010 – All rights reserved iii
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SIST EN ISO 15225:2010
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.
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SIST EN ISO 15225:2010
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).
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SIST EN ISO 15225:2010
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SIST EN ISO 15225:2010
INTERNATIONAL STANDARD ISO 15225:2010(E)
Medical devices — Quality management — Medical device
nomenclature data structure
1 Scope
This International Standard 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.
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 data file.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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
base concept
broadest representation of the generic device group, and the primary listing basis of the GMDN
[GMDN Agency]
3.2
character
member of a set of elements used for the organization, control or representation of data
[ISO/IEC 8859-1:1998, definition 4.3]
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 are used.
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SIST EN ISO 15225:2010
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3.3
code
system of alpha, alphanumeric or numeric characters and rules by which information is represented,
communicated, or both
3.4
collective term
term used to describe broad common features or characteristics within which a number of generic device
group terms are recognized, for regulatory or other purposes
NOTE Generic devices can be linked to one or more collective terms to indicate, for example, the following:
⎯ common areas of intended use;
⎯ the application of common technology;
⎯ the use of specific hazardous or difficult materials;
⎯ the application of a particular medical speciality;
⎯ the need for application of specific manufacturing processes;
⎯ the presence of other common attributes with which to identify certain devices;
⎯ the common descriptor of a broad device concept (i.e. a template term).
3.5
concept
unit of knowledge created by a unique combination of characteristics
[ISO 1087-1:2000, definition 3.2.1]
3.6
definition
formal concise statement of the meaning of a preferred term or template term
3.7
device category
broadest grouping within the nomenclature
3.8
device intended for clinical investigation
device intended for use in a designed and planned systematic study in or on human subjects to verify the
safety, performance, or both
3.9
device intended for performance evaluation
device intended by the manufacturer to be subject to performance evaluation studies in laboratories for
medical analyses or other appropriate environments outside the manufacturer’s premises
3.10
device type
identification of a manufacturer’s specific product
NOTE The manufacturer's specific product is the make and model.
3.11
file
named set of records stored or processed as a unit
[ISO/IEC 2382-1:1993, definition 01.08.06]
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ISO 15225:2010(E)
3.12
foreign key
〈relation〉 one or a group of attributes that corresponds to a primary key in another relation
[ISO/IEC 2382-17:1999, definition 17.04.15]
3.13
generic device group
set of devices having the same or similar intended use, common technology, or both
3.14
Global Medical Device Nomenclature
GMDN
nomenclature based on the structure of this International Standard, which provides information in the form of a
code to indicate the generic descriptor within which a device type can be identified
NOTE By reference to this globally accepted, generic medical device nomenclature, other particular devices which
have substantially similar generic features but which come from another source can be identified, for reasons of data
exchange between competent authorities and others, for the exchange of post-market vigilance information and for
inventory purposes.
3.15
GMDN agency
organization representing the interests of regulatory agencies, manufacturers and healthcare providers to
ensure the continued relevance and effectiveness of the GMDN, and is responsible for the development,
control and distribution of the GMDN
3.16
identifier
〈organization of data〉 one or more characters used to identify or name a data element and possibly to indicate
certain properties of that data element
[ISO/IEC 2382-4:1999, definition 04.09.02]
3.17
multiple-linked synonym
alternative name(s) for a synonym term linked to more than one preferred or template term
[GMDN Agency]
3.18
name
verbal designation of an individual concept
NOTE Adapted from ISO 1087-1:2000, definition 3.4.2.
3.19
nomenclature
terminology structured systematically according to pre-established naming rules
[ISO 1087-1:2000, definition 3.5.3]
3.20
preferred term
name established to describe a device, or devices, having the same or similar intended use or commonality of
technology
3.21
primary key
a key that identifies one record
[ISO/IEC 2382-17:1999, definition 17.03.11]
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3.22
product specifier
marker to indicate which terms can and cannot be used for product identification
[GMDN Agency]
3.23
relational structure
data structure in which the data are arranged as relations
[ISO/IEC 2382-17:1999, definition 17.04.03]
3.24
secondary key
a key that is not a primary key, but for which an index is maintained and that may denote more than one
record
[ISO/IEC 2382-17:1999, definition 17.03.12]
3.25
synonym
alternative name for a preferred or template term
3.26
template specifier
data field which is set to indicate that the term is a template term and, at the same time, which specifies that
the first characters from the term field are used to look up the preferred terms that start with the same
characters
3.27
template term
term used to create a simple hierarchy for preferred terms
3.28
term
verbal designation of a general concept in a specific subject field
NOTE Adapted from ISO 1087-1:2000, definition 3.4.3.
4 Principle of structure
4.1 General
The nomenclature is structured in four stages. These stages differ in the breadth of the sets of devices
represented by the terms defined within each stage. All medical devices can be classified within each stage.
The stages have a relational structure in the following order:
a) device category (see 4.2);
b) collective term (see 4.3);
c) generic device group (see 4.4);
d) device type (see 4.5).
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SIST EN ISO 15225:2010
ISO 15225:2010(E)
4.2 Device category
Individual categories have broad usage definitions representing disparate devices that have common areas of
intended use or common technology. Device category has the largest number of devices covered by each
term.
For data organization, device category includes the record holding a device category term and associated
data, such as its code and other attributes.
4.3 Collective term
Collective terms are terms used in the nomenclature for:
a) grouping together preferred terms with common characteristics, e.g. common technology, materials,
medical specialties, manufacturing processes;
NOTE Collective terms can replace or support template terms.
b) illustrating the scope of certificates issued by certification bodies when assessing which groups, families
or types of medical devices are covered within a manufacturer’s quality system;
c) identifying the range of skills and general technological abilities for which a notified body has been
approved, and is so appointed by the relevant regulatory authority;
d) exchanging of information between regulatory authorities when general information on individual
manufacturers capabilities is notified for inclusion within data-exchange systems.
Collective terms are linked directly to preferred terms.
4.4 Generic device group
A generic device group contains sets of devices having the same or similar intended uses or commonality of
technology. Sets of devices are grouped together for the purpose of device vigilance reporting, or other
purposes where sets of essentially similar devices from different sources need to be collected. Potentially, any
device attribute (e.g. implant/non-implant, sterile/non-sterile) can be used as a means of arranging associated
data.
For data organization, the generic device group includes the record holding a device group term. The device
group term can include the following:
a) preferred term (see 5.2.3);
b) template term (see 5.2.4);
c) synonym (see 5.2.5);
d) multiple-linked synonym (see 5.2.6).
It can also include associated data, as follows:
⎯ code;
⎯ definition;
⎯ for synonyms or multiple-linked synonyms, code of the generic device group record holding the preferred
term or template term;
⎯ for templates, the template specifier.
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SIST EN ISO 15225:2010
ISO 15225:2010(E)
4.5 Device type
A device type contains individual medical devices including devices intended for clinical investigation, devices
intended for performance evaluation and custom-made devices or sets of medical devices including variants
which may be produced. Device types contain sufficient characteristics in common for the manufacturer to
establish a make and model.
For data organization, device type includes the record holding the device type designation and its associated
data, such as its code and other attributes.
Names to be stored are drawn from the manufacturer’s documentation.
4.6 Nomenclature structure example
Table 1 is an example of the nomenclature structure.
Table 1 — Example of GMDN structure linked to an alignment rod
03 Dental devices
Device categories:
09 Reusable devices
Links to - -
Collective terms:
CT465 Cranial surgery
CT146 Dentistry
CT317 Infant/paediatric
CT321 Long-term surgical invasive
CT326 Manually powered/operated
CT177 Metals
CT328 Natural orifice
CT166 Oral surgical fixation/distraction and ancillary
CT152 Paediatrics
CT982 Reusable
CT335 Single purpose
CT334 Single-patient use
CT337 Sterilizable
CT233 Surgery
Links to - -
GMDN code:47677
Term: Craniofacial alignment rod
Definition: A surgical instrument typically used in pairs to facilitate correct cranial orientation of
craniofacial implants (e.g., fixation plates being attached to jaw bones) and other devices (e.g.
Generic device group:
craniofacial distractors) during their application in craniofacial surgery. It is typically designed as
a long, thin, rigid rod made of high-grade stainless steel or titanium alloy with connectors at either
end for attachment to the devices being aligned; it may have a knurled mid section (to provide
better grip) onto which other instruments can be locked to assist the orientation procedure. This
is a reusable device.
Links to - -
Make: Acme
Device type: Model: 298FK3Z
Trade name: Alignment rod
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SIST EN ISO 15225:2010
ISO 15225:2010(E)
5 Requirements
5.1 Device category
Device categories are managed by the GMDN agency and are part of the data file.
The list is not exhaustive, other device categories may be added (see Annex A).
5.2 Generic device group
5.2.1 General
Generic device groups are managed by the GMDN agency and are part of the data file.
For the generation of generic device group terms, see Annex B.
A generic device group can be a member of more than one device category.
The nomenclature shall consist of preferred terms, template terms, synonyms and multiple-linked synonyms.
All terms should be given in the singular form.
5.2.2 Abbreviations and acronyms
Abbreviations and acronyms can be used to create generic device group names.
Any abbreviation being adopted should use widely recognized terminology.
5.2.3 Preferred term
A preferred term represents a device type or a set of device types that perform similar or equivalent functions
or have technical characteristics in common.
A preferred term is the only term that can be used for product identification.
A preferred term shall be unambiguous and comprise the following:
a) base concept;
b) (if appropriate) one or more qualifiers following the base concept, and which are separated from the base
concept by a comma;
c) a comma and one space to delimit each qualifier.
EXAMPLE Brachytherapy system applicator, remote afterloading, bladder.
More specific classification can be achieved by addition of further qualifiers.
The base concept shall be the primary listing basis.
Unambiguous qualifiers shall be used.
Ambiguous qualifiers include phrases such as “sundries”, “others”, “appliances”, “miscellaneous” and “various”.
Trade names shall not be used as preferred terms.
Preferred terms shall be assigned a definition of not more than 700 characters.
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SIST EN ISO 15225:2010
ISO 15225:2010(E)
5.2.4 Template terms
A template term is used when more than two preferred terms are formed using the same base concept.
The template term shall be formed from the common base concept followed by the qualifier .
A template term functions only as a navigational term within the nomenclature. Its permanency cannot be
guaranteed due to preferred term development.
Template terms cannot be used for product identification.
Template terms shall not be used as synonyms.
Template terms shall be assigned a definition of not more than 700 characters.
5.2.5 Synonyms
Synonyms shall be linked to only one preferred term or to one template term, whichever is appropriate.
Synonyms are an aid to locating the appropriate preferred term.
Synonym terms cannot be used for product identification.
...
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