EN 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.

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2010
• Withdrawal Date: 05-Apr-2016
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 01.040.35 - Information technology (Vocabularies)
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Apr-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15225:2010 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

Relations

• Replaces: EN ISO 15225:2000 - Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)
• Effective Date: 12-May-2010
• Replaces: EN ISO 15225:2000/A2:2005 - Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)
• Effective Date: 12-May-2010
• Replaces: EN ISO 15225:2000/A1:2004 - Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)
• Effective Date: 12-May-2010
• Replaced By: EN ISO 15225:2016 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
• Effective Date: 08-Jun-2022

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.

---------------------- Page: 1 ----------------------

SIST EN ISO 15225:2010

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

SIST EN ISO 15225:2010
EN ISO 15225:2010 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

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
...