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- Withdrawn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
- 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 - Medical devices
Relations
- Effective Date
- 12-May-2010
- Effective Date
- 08-Jun-2022
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 15225:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)". This standard covers: 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.
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.
EN ISO 15225:2000 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.040.01 - Medical equipment in general; 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15225:2000 has the following relationships with other standards: It is inter standard links to EN ISO 15225:2010, EN ISO 15225:2000/A1:2004, EN ISO 15225:2000/A2:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15225:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 15225:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2000
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]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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