SVENSK STANDARD SS-ENV 13004
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Hälso- och sjukvårdsstandardiseringen, HSS
2000-03-24 1 1 (1+8)© Copyright SIS. Reproduction in any form without permission is prohibited.
ICS 01.040.11; 01.040.35; 11.040.01; 35.240.70
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Nomenclature system for medical devices for the purposes of regula- tory data exchange – Recommen- dations for an interim system and rules for a future system
The European Prestandard ENV 13004:1999 has the status of a Swedish Standard. This document contains the official English version of ENV 13004:
1999.
Swedish Standards corresponding to documents referred to in this Standard are listed in ”Catalogue of Swedish Standards”, issued by SIS. The Cata- logue lists, with reference number and year of Swedish approval, International and European Standards approved as Swedish Standards as well as other Swedish Standards.
Nomenklatursystem för beskrivning av medicintekniska produkter för att möjliggöra ett enhetligt system för utbyte av data – Rekommenda- tioner för ett tillfälligt system och regler för ett framtida system
Den europeiska förstandarden ENV 13004:1999 gäller som svensk standard. Detta dokument in- nehåller den officiella engelska versionen av ENV 13004:1999.
Motsvarigheten och aktualiteten i svensk standard
till de publikationer som omnämns i denna stan-
dard framgår av ”Katalog över svensk standard”,
som ges ut av SIS. I katalogen redovisas interna-
tionella och europeiska standarder som fastställts
som svenska standarder och övriga gällande svenska
standarder.
EUROPEAN PRESTANDARD PRÉNORME EUROPÉENNE EUROPÄISCHE VORNORM
ENV 13004
July 1999
ICS 01.040.11; 01.040.35; 11.040.01; 35.240.70
English version
Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim
system and rules for a future system
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
Nomenklatursysteme für Medizinprodukte zum Zwecke des regulativen Datenaustauschs - Empfehlungen für ein Übergangssystem und Regeln für ein zukünftiges System
This European Prestandard (ENV) was approved by CEN on 6 May 1999 as a prospective standard for provisional application.
The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the ENV can be converted into a European Standard.
CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E U R O P É E N D E N O R M A L I S A T I O N E U R O P Ä I S C H E S K O M I T E E F Ü R N O R M U N G
Central Secretariat: rue de Stassart, 36 B-1050 Brussels
© 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
Ref. No. ENV 13004:1999 E
