EN ISO 15225:2016

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

ISO 15225:2016 specifies 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, healthcare providers and end users.
ISO 15225:2016 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.
ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.

Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von Medizinprodukten (ISO 15225:2016)

Diese Internationale Norm legt Regeln fest und enthält Richtlinien für eine Datenstruktur für die Nomenklatur von Medizinprodukten, um die Zusammenarbeit und den Austausch von behördlich relevanten Daten auf internationaler Ebene zwischen den betreffenden Stellen, wie Behörden, Hersteller, Lieferanten, Einrichtungen der Gesundheitsversorgung 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 Internationalen Norm enthaltenen Anforderungen gelten für die Entwicklung und Pflege einer internationalen Nomenklatur zur Identifikation von Medizinprodukten.
Diese Internationale Norm enthält nicht die eigentliche Nomenklatur, die als getrennte Datei bereitgestellt wird.

Dispositifs médicaux - Management de la qualité - Structure des données de nomenclature des dispositifs médicaux(ISO 15225:2016)

L'ISO 15225:2016 spécifie 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 15225:2016 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 15225:2016 sont applicables à la création et à la maintenance d'une nomenclature internationale destinée à l'identification des dispositifs médicaux.
L'ISO 15225:2016 n'inclut pas la nomenclature en elle-même, qui est fournie sous forme de fichier de données séparé.

Medicinski pripomočki - Vodenje kakovosti - Struktura podatkov za poimenovanje medicinskih pripomočkov (ISO 15225:2016)

Ta mednarodni standard določa pravila in smernice za strukturo podatkov za poimenovanje medicinskih pripomočkov z namenom olajšati sodelovanje in izmenjavo podatkov, ki jih uporabljajo regulativni organi na mednarodni ravni, med zainteresiranimi stranmi, kot so regulativni organi, proizvajalci, dobavitelji,
ponudniki zdravstvenih storitev in končni uporabniki.
Ta mednarodni standard vključuje smernice za minimalni podatkovni sklop in njegovo strukturo. Smernice so namenjene načrtovalcem sistemov pri vzpostavljanju zbirk podatkov, ki uporabljajo tukaj opisan sistem poimenovanja.
Zahteve v tem mednarodnem standardu se uporabljajo za razvoj in vzdrževanje mednarodnega poimenovanja za identifikacijo medicinskih pripomočkov.
Ta mednarodni standard ne vključuje dejanskega poimenovanja; to je na voljo kot ločena podatkovna datoteka.

General Information

• Status: Withdrawn
• Publication Date: 05-Apr-2016
• Withdrawal Date: 19-Dec-2017
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 01.040.35 - Information technology (Vocabularies)
• ICS: 11.040.01 - Medical equipment 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: 20-Dec-2017
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15225:2016 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

Relations

• Replaces: EN ISO 15225:2010 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15225:2016
01-junij-2016
1DGRPHãþD
SIST EN ISO 15225:2010
0HGLFLQVNLSULSRPRþNL9RGHQMHNDNRYRVWL6WUXNWXUDSRGDWNRY]DSRLPHQRYDQMH
PHGLFLQVNLKSULSRPRþNRY,62
Medical devices - Quality management - Medical device nomenclature data structure
(ISO 15225:2016)
Medizinprodukte - Qualitätsmanagement - Datenstruktur für die Nomenklatur von
Medizinprodukten (ISO 15225:2016)
Dispositifs médicaux - Management de la qualité - Structure des données de
nomenclature des dispositifs médicaux(ISO 15225:2016)
Ta slovenski standard je istoveten z: EN ISO 15225:2016
ICS:
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
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 15225:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15225:2016

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SIST EN ISO 15225:2016


EUROPEAN STANDARD
EN ISO 15225

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2016
ICS 01.040.11; 01.040.35; 11.040.01; 35.240.80
Supersedes EN ISO 15225:2010
English version

Medical devices - Quality management - Medical device
nomenclature data structure (ISO 15225:2016)
Dispositifs médicaux - Management de la qualité - Medizinprodukte - Qualitätsmanagement -
Structure des données de nomenclature des dispositifs Datenstruktur für die Nomenklatur von
médicaux(ISO 15225:2016) Medizinprodukten (ISO 15225:2016)
This European Standard was approved by CEN on 9 June 2016.

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-CENELEC 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-CENELEC
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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.






















CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 15225:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST EN ISO 15225:2016
EN ISO 15225:2016 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 15225:2016
EN ISO 15225:2016 (E)
European foreword
This document (EN ISO 15225:2016) 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 October 2016, and conflicting national standards shall
be withdrawn at the latest by October 2016.
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 15225:2010.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Swe
...