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EN ISO 15225:2000

(Main)

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.

Nomenklatur - Spezifikation für ein Nomenklatursystem für Medizinprodukte zum Zweck des regulativen Datenaustauschs (ISO 15225:2000)

Diese Europäische Norm legt Anforderungen und einen Leitfaden zur Erstellung eines Nomenklatursystems für Medizinprodukte fest, die die Möglichkeiten der Zusammenarbeit und den regulativen Austausch von Daten auf internationaler Ebene zwischen den interessierten Stellen wie Behörden, Herstellern, Lieferanten, Personal im Gesundheitswesen und Endbenutzern aufzeigt.

Nomenclature - Spécifications pour un système de nomenclature des dispositifs médicaux destinés à l'échange de données réglementaires (ISO 15225:2000)

La présente norme européenne spécifie les exigences et les recommandations destinées à l'élaboration d'un système de nomenclature des dispositifs médicaux pour faciliter la coopération et les échanges de données réglementaires à un niveau international entre les parties intéressés comme: les autorités réglementaires, les fabricants, les fournisseurs, les fournisseurs de soins de santé, et les utilisateurs finaux.

Poimenovanje - Specifikacija za sistem poimenovanja medicinskih pripomočkov za obvezno izmenjavo podatkov (ISO 15225:2000)

General Information

Status
Withdrawn
Publication Date
31-Jan-2000
Withdrawal Date
30-Apr-2010
ICS
01.040.11 - Health care technology (Vocabularies)
11.040.01 - Medical equipment in general
11.120.01 - Pharmaceutics in general
Technical Committee
CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
Drafting Committee
CEN/TC 257/SC 1 - Nomenclature for medical devices
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-May-2010
Completion Date
01-May-2010
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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 15225:2000 - Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

Relations

Replaced By
EN ISO 15225:2010 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Effective Date
12-May-2010
Amended By
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
08-Jun-2022
Amended By
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
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15225:2000
01-julij-2000
3RLPHQRYDQMH6SHFLILNDFLMD]DVLVWHPSRLPHQRYDQMDPHGLFLQVNLKSULSRPRþNRY
]DREYH]QRL]PHQMDYRSRGDWNRY ,62
Nomenclature - Specification for a nomenclature system for medical devices for the
purpose of regulatory data exchange (ISO 15225:2000)
Nomenklatur - Spezifikation für ein Nomenklatursystem für Medizinprodukte zum Zweck
des regulativen Datenaustauschs (ISO 15225:2000)
Nomenclature - Spécifications pour un systeme de nomenclature des dispositifs
médicaux destinés a l'échange de données réglementaires (ISO 15225:2000)
Ta slovenski standard je istoveten z: EN ISO 15225:2000
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
SIST EN ISO 15225:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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