Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

This European prestandard gives guidance for the nomenclature of medical devices for regulatory data exchange. It is intended for use by Competent Authorities, Notified Bodies and manufacturers of medical devices.

Nomenklatursysteme für Medizinprodukte zum Zwecke des regulativen Datenaustauschs - Empfehlungen für ein Übergangssystem und Regeln für ein zukünftiges System

Diese Europa(ische Vornorm gibt eine Anleitung zur Nomenklatur von Medizinprodukten fu(r den regulativen Datenaustausch. Sie ist fu(r zusta(ndige Beho(rden, benannte Stellen und Hersteller von Medizinprodukten vorgesehen.

Système de nomenclature des dispositifs médicaux aux fins d'échanges de données réglementaires - Recommandations relatives à un système intérimaire et règles applicables à un futur système

La présente prénorme européenne donne des indications pour la nomenclature des dispositifs médicaux en ce qui concerne les échanges de données réglementaires. Elle est destinée aux autorités compétentes, aux organismes notifiés et aux fabricants de dispositifs médicaux.

Sistem poimenovanja medicinskih pripomočkov za obvezno izmenjavo podatkov - Priporočila za začasni sistem in pravila za prihodnji sistem

General Information

Status
Withdrawn
Publication Date
20-Jul-1999
Withdrawal Date
20-Jan-2026
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
17-Jun-2020
Completion Date
21-Jan-2026
Standardization document

ENV 13004:2000

English language
8 pages
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Frequently Asked Questions

ENV 13004:1999 is a standardization document published by the European Committee for Standardization (CEN). Its full title is "Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system". This standard covers: This European prestandard gives guidance for the nomenclature of medical devices for regulatory data exchange. It is intended for use by Competent Authorities, Notified Bodies and manufacturers of medical devices.

This European prestandard gives guidance for the nomenclature of medical devices for regulatory data exchange. It is intended for use by Competent Authorities, Notified Bodies and manufacturers of medical devices.

ENV 13004:1999 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 01.040.35 - Information technology (Vocabularies); 11.040.01 - Medical equipment in general; 35.240.70 - IT applications in science. The ICS classification helps identify the subject area and facilitates finding related standards.

ENV 13004:1999 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
6LVWHPSRLPHQRYDQMDPHGLFLQVNLKSULSRPRþNRY]DREYH]QRL]PHQMDYRSRGDWNRY
3ULSRURþLOD]D]DþDVQLVLVWHPLQSUDYLOD]DSULKRGQMLVLVWHP
Nomenclature system for medical devices for the purposes of regulatory data exchange -
Recommendations for an interim system and rules for a future system
Nomenklatursysteme für Medizinprodukte zum Zwecke des regulativen Datenaustauschs
- Empfehlungen für ein Übergangssystem und Regeln für ein zukünftiges System
Systeme de nomenclature des dispositifs médicaux aux fins d'échanges de données
réglementaires - Recommandations relatives a un systeme intérimaire et regles
applicables a un futur systeme
Ta slovenski standard je istoveten z: ENV 13004:1999
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 tech
...

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