ENV 13004:1999
(Main)Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
General Information
- Abstract
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.
- Status
- Withdrawn
- Publication Date
- 20-Jul-1999
- Withdrawal Date
- 08-Sep-2026
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 17-Jun-2020
- Completion Date
- 09-Sep-2026
Relations
- Effective Date
- 28-Jan-2026
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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 has the following relationships with other standards: It is inter standard links to EN 12220:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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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