ENV 13004:1999

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

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Jun 17, 2020


CEN/TC 257 Symbols and information provided with medical devices and nomenclature for regulatory data exchange

Pre Standard

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



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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.

Life cycle


ENV 13004:1999
99.60 Withdrawal effective
Jun 17, 2020