EN ISO 15225:2000/A2:2005

SLOVENSKI STANDARD
01-september-2005
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Nomenclature - Specification for a nomenclature system for medical devices for the
purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)
Nomenklatur - Spezifikation für ein Nomenklatursystem für Medizinprodukte zum Zweck
des regulativen Datenaustauschs (ISO 15225:2000/Amd 1:2004)
Nomenclature - Spécifications pour un systeme de nomenclature des dispositifs
médicaux destiné a l'échange de données réglementaires (ISO 15225:2000/Amd
1:2004)
Ta slovenski standard je istoveten z: EN ISO 15225:2000/A2:2005
ICS:
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 15225:2000/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2005
ICS 11.040.01; 35.240.80
English version
Nomenclature - Specification for a nomenclature system for
medical devices for the purpose of regulatory data exchange
(ISO 15225:2000/Amd 1:2004)
Nomenclature - Spécifications pour un système de Nomenklatur - Spezifikation für ein Nomenklatursystem für
nomenclature des dispositifs médicaux destiné à l'échange Medizinprodukte zum Zweck des regulativen
de données réglementaires (ISO 15225:2000/Amd 1:2004) Datenaustauschs (ISO 15225:2000/Amd 1:2004)
This amendment A2 modifies the European Standard EN ISO 15225:2000; it was approved by CEN on 27 June 2005.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Central Secretariat or to any CEN member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.
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. EN ISO 15225:2000/A2:2005: E
worldwide for CEN national Members.

Foreword
This document (EN 15225:2000/A2:2005) 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 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 January 2006, and conflicting national
standards shall be withdrawn at the latest by January 2006.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZC, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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.

Endorsement notice
The text of ISO 15225:2000/Amd 1:2004 has been approved by CEN as EN ISO 15225:2000/
A2:2005 without any modifications.
Contents
At the end of the existing table of contents in EN ISO 15225:2000, insert the following new entry:

Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of Directive 98/79/EC

Add the following Annex ZC.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 98/79/EC

This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 98/79/EC.

Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative clauses of this standard given in Table ZC.1 confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
Table ZC.1 - Correspondence between this European Standard and Directive 98/79/EC
Clause(s)/Sub-clause(s) of this European Essential requirements (ERs) from Qualifying Remarks /Notes
Standard Council Directive on in vitro
diagnostic medical devices
(98/79/EC)
6.2, 6.3, 6.4, 6.5 Article 4, Clause 4
This standard Article 8, Clause 3
This standard Article 9, Clause 4
This standard Article 10, Clauses 1, 2, 4, 5, 6
This standard Article 11, Clauses 1, 2, 3
This standard Article 12, Clauses 1,2, 3
This standard Article 14, Clauses 1, 2, 3
This standard Article 15, Clauses 5, 6
This standard Annex I, Clause B.8.4 b)
This standard Annex I, Clause B.8.7 a)
This standard Annex I, Clause B.8.7.m
This standard, 5.3, 6 Annex III
...