SIST EN 13612:2002/AC:2003

Performance evaluation of in vitro diagnostic medical devices

TC - Modifications in 2.6, 2.14, 4.5, Annex ZA and Bibliography

Leistungsbewertung von In-vitro-Diagnostika

Détermination des performances des dispositifs médicaux pour diagnostic in vitro

Ovrednotenje diagnostičnih medicinskih pripomočkov lastnosti in vitro

General Information

• Status: Published
• Publication Date: 28-Feb-2003
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Mar-2003
• Due Date: 01-Mar-2003
• Completion Date: 01-Mar-2003
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: EN 13612:2002/AC:2002 - Performance evaluation of in vitro diagnostic medical devices

Relations

• Corrects: SIST EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LWURLeistungsbewertung von In-vitro-DiagnostikaDétermination des performances des dispositifs médicaux pour diagnostic in vitroPerformance evaluation of in vitro diagnostic medical devices11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN 13612:2002/AC:2002SIST EN 13612:2002/AC:2003en01-marec-2003SIST EN 13612:2002/AC:2003SLOVENSKI
STANDARD



SIST EN 13612:2002/AC:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13612:2002/ACDecember 2002Décembre 2002Dezember 2002ICS 11.100English versionVersion FrançaiseDeutsche FassungPerformance evaluation of in vitro diagnostic medical devicesDétermination des performances des dispositifs médicaux pourdiagnostic in vitroLeistungsbewertung von In-vitro-DiagnostikaThis corrigendum becomes effective on 18 December 2002 for incorporation in the three officiallanguage versions of the EN.Ce corrigendum prendra effet le 18 décembre 2002 pour incorporation dans les trois versionslinguistiques officielles de l'EN.Die Berichtigung tritt am 18. Dezember 2002 zur Einarbeitung in die drei offiziellen Sprachfassungender EN in Kraft.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members.Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier auxmembres nationaux du CEN.Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedernvon CEN vorbehalten.Ref. No. EN 13612:2002/AC:2002 D/E/FSIST EN 13612:2002/AC:2003



EN 13612:2002/AC:2002 (E/F/D)2English version2.6lay person"EN ISO 9000:2000, 3.8.5" has to be replaced as follows: "[EN 376:2002]"2.14validation"ISO 9000, 3.8.5" has to be replaced as follows:
"[EN ISO 9000:2000, 3.8.5]"4.5
Experimental designIn the 14 th dash "expected" has to be replaced by "unexpected" as follows:– availability of additional information concerning the specimen or donor if follow-up ofunexpected results is required;Annex ZA (informative) - Clauses of this European Standard addressing essentialrequirements or other provisions of EU Directives"EU" has to be deleted three times as follows:The following clauses of this standard, as detailed in Table ZA.1, are likely to support requirements ofthe EU Directive 98/79/EC.Table ZA.1 - Correspondence between this European Standard and EU Directive 98/79/ECClauses/subclauses of thisEuropean StandardEssential requirements of EUDirective 98/79/ECQualifying remarks/notesBibliographyThe refenences list has to be re-organized to the following order "ENs, EN ISOs, ISOs, otherdocuments" and the chan
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