SIST-TP CEN/TR 15133:2005

SLOVENSKI STANDARD
SIST-TP CEN/TR 15133:2005
01-september-2005
3RLPHQRYDQMH±=EUDQLL]UD]LLQNRGH]DVNXSLQHPHGLFLQVNLKSULSRPRþNRY
Nomenclature - Collective terms and codes for groups of medical devices
Nomenklatur - Sammelbegriffe und Kodes für Gruppen von Medizinprodukten
Nomenclature - Termes et codes collectifs pour les groupes de dispositifs médicaux
Ta slovenski standard je istoveten z: CEN/TR 15133:2005
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST-TP CEN/TR 15133:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 15133:2005

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SIST-TP CEN/TR 15133:2005
TECHNICAL REPORT
CEN/TR 15133
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
June 2005
ICS 01.040.11; 11.040.01
English version
Nomenclature - Collective terms and codes for groups of
medical devices
Nomenclature - Termes et codes collectifs pour les Nomenklatur - Sammelbegriffe und Kodes für Gruppen von
groupes de dispositifs médicaux Medizinprodukten
This Technical Report was approved by CEN on 6 May 2005. It has been drawn up by the Technical Committee CEN/TC 257.
CEN members are the national standards bodies of Austria, Belgium, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15133:2005: E
worldwide for CEN national Members.

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SIST-TP CEN/TR 15133:2005
CEN/TR 15133:2005 (E)
Contents Page
Foreword .3
Introduction.4
1 Scope .5
2 Lists of collective terms .5
2.1 Application of Common Technology.5
2.2 Using similar manufacturing procedures .11
2.3 For similar medical procedures .12
2.4 Using common materials.13
2.5 Specific risk-associated considerations .14
Bibliography.15

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SIST-TP CEN/TR 15133:2005
CEN/TR 15133:2005 (E)
Foreword
This document (CEN/TR 15133:2005) has been prepared by Technical Committee CEN/TC 257 “Symbols
and information provided with medical devices and nomenclature for regulatory data exchange”, the
secretariat of which is held by SFS.
This CEN report has been prepared under the mandate (M321) given to CEN by the European Commission
and the European Free Trade Association.
This CEN Report is intended to complement the specific requirements of the EU regulations on medical
devices relating to information exchanged between parties communicating in conformity with requirements of
the Directives.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this CEN Technical Report: Austria, Belgium, 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.
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Introduction
This Technical Report contains collective terms for those medical devices which share common features and
are identified in the Global Medical device Nomenclature (GMDN), published as CR 14230:2001 Global
medical device nomenclature for the purpose of regulatory data exchange (identical to ISO/TS 20225:2001
Whereas the GMDN is designed and was developed for regulatory data exchange in areas such as vigilance
reporting and tracking of medical device safety, there is a need for a set of terms that are more refined than
the GMDN category terms, yet broader than the GMDN generic device group terms, to be used in the
application of the medical device directives where the use of collective terms provides adequate identification.
These collective terms are intended to be used for example:
 to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or
types of medical devices are covered within a manufacturer’s quality system,
 to be used to identify the range of skills and general technological abilities for which a Notified Body has
been approved, and is so appointed by the relevant Competent Authority,
 for the exchanges of information between Competent Authorities when general information on individual
manufacturers capabilities is notified for inclusion in the European Database for Medical Devices
(EUDAMED).
These terms, named "collective terms", are appropriate for providing general groupings to meet, in particular,
the above identified requirements.
In the preparation of this CEN REPORT a number of principles were identified which were used in grouping
together generic device group terms of the GMDN within the proposed “collective terms”. These were:
 Devices covered by the application of common technology
 Devices manufactured using similar manufacturing procedures, and with common technical features.
 Devices manufactured for the application of similar Medical Procedures
 Devices manufactured using common materials requiring special skills.
 Devices developed to meet specific risk-associated considerations.
For ease of electronic transmission of data, and to eliminate the possibility of confusion with other coding
systems having a three-digit code used for information concerning Medical Devices, each collective term is
assigned a three-digit random code with the prefix “CT” (Collective Term), which identifies the code source.
It is expected that as the collective terms are brought into use, they will be assigned to the generic device
group terms of the GMDN. The Maintenance Agency (MA) of the GMDN will make these links available.
Details of progress in this area will be posted on the MA web site at http://www.gmdn.org.
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1 Scope
This Technical Report lists collective terms and codes for groups of medical devices having common features.
The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for
communication relevant to the application of the medical device regulation.
For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the
development of a list of collective terms based on the identified principles to be used, for examples, as follows:
 to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or
types of medical devices are covered within a manufacturer’s quality system,
 to be used to identify the range of skills and general technological abilities for which a Notified Body has
been approved, and is so appointed by the relevant Competent Authority,
 for the exchanges of information between Competent Authorities when general information on individual
manufacturers capabilities is notified for inclusion in the European Database for Medical Devices
(EUDAMED).
For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto
in the corresponding medical device collective term.
2 Lists of collective terms
NOTE 1 Any specific Generic Device term from the GMDN may be assignable to more than one of the collective terms
listed here.
NOTE 2 When assigning collective terms for any of the particular uses outlined in the Introduction, more than one
collective term may be assigned, if required, to improve the definition of the specified circumstances under which the
assignment is being made.
NOTE 3 The collective term(s) selected for any set of circumstances should cover the broadest scope in the grouping
for which a selection is required so that the smallest set of collective terms that will describe the situation will be the one
used.
NOTE 4 When using the collective term codes to communicate information, the “CT” prefix must be used to identify
the code source.
2.1 Application of Common Technology
Any specific Generic Device group term from the GMDN shall be assignable to at least one of the collective
terms listed as “Common technology”.

Applicable GMDN
Categories
ct code Collective Terms
1  2 3
CT: 231 Ablation devices 9 10

CT: 005 Absorbable implants 7 3

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Applicable GMDN
Categories
ct code Collective Terms
1  2  3

CT: 192 Accelerator systems 12

CT: 006 Acoustic chambers 4

CT: 007 Airways/respiratory systems 10

CT: 008 Ambulances and ancillary devices 5

CT: 009 Anaesthesia units/work stations and ancillary devices 2 3

CT: 010 Analgesia devices 2

CT:413 Analyzers 5    6

CT: 011 Angioplasty systems/devices 10

CT: 012 Bandages 10

CT: 013 Bedding/mattresses/pillows 5

CT: 102 Beds for medical purposes 11

CT: 096 Blood collecting devices 10

CT: 071 Blood flow measurement devices 4

CT: 066 Blood gas analysers 4 6

CT: 014 Blood pressure measuring devices invasive/non- invasive 4

CT: 097 Blood transfusion
...