EN 13532:2002

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.General requirements for in vitro diagnostic medical devices for self-testingãDQMHExigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-testAllgemeine Anforderungen an In-vitro-Diagnostika zur EigenanwendungTa slovenski standard je istoveten z:EN 13532:2002SIST EN 13532:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13532:200201-november-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13532April 2002ICS 11.100English versionGeneral requirements for in vitro diagnostic medical devices forself-testingExigences générales relatives aux dispositifs médicaux dediagnostic in vitro destinés à des auto-diagnosticsAllgemeine Anforderungen an In-vitro-Diagnostika zurEigenanwendungThis European Standard was approved by CEN on 27 December 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.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 reservedworldwide for CEN national Members.Ref. No. EN 13532:2002 E

A specimen receptacle, whether vacuum-type or not, specifically intended by its manufacturer for the primary containmentand preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination is considered to be anin vitro diagnostic medical device.NOTE 2
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of theircharacteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.3.2lay personindividual who does not have specific medical education[EN 376:2002]3.3markinginscription, in writing or as a graphical symbol, permanently affixed to a productNOTE
Examples for inscriptions are manufacturer’s or distributor’s trademark, model or type number, identification of intendedfunctions, supply voltage, particular warnings.
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