SIST EN 13532:2002
(Main)General requirements for in vitro diagnostic medical devices for self-testing
General requirements for in vitro diagnostic medical devices for self-testing
This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.
Allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung
Diese Europäische Norm legt allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung fest. Sie soll sicherstellen, dass In-vitro-Diagnostika zur Eigenanwendung sicher und für die vom Hersteller angegebenen Zwecke geeignet sind.
Diese Norm behandelt keine medizinischen Aspekte von In-vitro-Diagnostika zur Eigenanwendung.
Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test
La présent Norme européenne spécifie les exigences générales relatives aux dispositifs médicaux de diagnostic in vitro (DM - DIV) pour auto-test, afin de s'assurer que les DMs - DIV pour auto-test sont surs et adaptés aux besoins, comme spécifié par le fabricant.
La présente norme n'aborde pas les aspects médicaux des DMs - DIV pour auto-test.
Splošne zahteve za diagnostične pripomočke in vitro za samopreskušanje
General Information
Standards Content (Sample)
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
EN 13532:2002 (E)2ForewordThis document EN 13532 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medicaldevices", the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by October 2002, and conflicting national standards shall be withdrawn at the latestby October 2002.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.This standard includes a Bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 13532:2002 (E)31ScopeThis European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) forself-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by themanufacturer.This standard does not address medical aspects of IVD MDs for self-testing.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. For datedreferences, subsequent amendments to or revisions of any of these publications apply to this European Standard onlywhen incorporated in it by amendment or revision. For undated references the latest edition of the publication referredto applies (including amendments).EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.EN 592, Instructions for use for in vitro diagnostic instruments for self-testing.EN 1658, Requirements for marking of in vitro diagnostic instruments.EN 13612, Performance evaluation of in vitro diagnostic medical devices.EN 61010-1:2001, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1:General requirements (IEC 61010-1:2001).EN 61326, Electrical equipment for measurement, control and laboratory use – EMC requirements (IEC 61326:1997).3Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1in vitro diagnostic medical deviceany medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for theexamination of specimens, including blood and tissue donations, derived from the human body, solely or principally forthe purpose of providing information concerning a physiological or pathological state, or concerning congenitalabnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measuresNOTE 1
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.
EN 13532:2002 (E)43.4permanently affixedremovable only with a tool or by appreciable force and able to withstand the effects of temperature, rubbing, commonsolvents, reagents, and vapours encountered durin
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