EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.
The standard does not apply to the following:
   - instruments and specimen receptacles;
   NOTE 1   The prevention of infection due to handling of biological materials throughout such  equipment is addressed in other relevant International and/or European Standards.
   - general aspects of workers' protection;
   - transportation of infectious goods;
   - disposal measures.
   NOTE 2   Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Eliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehenden Infektionsrisikos

Diese Norm legt Anforderungen fest bezüglich des Designs und der Herstellung, um das Infektionsrisiko durch Reagenzien für in-vitro-diagnostische Untersuchungen einschließlich Reagenzprodukten, Kalibriermaterialien, Kontrollmaterialien und Kits, nachstehend IVD-Reagenzien genannt, wirksam unter Kontrolle zu halten. Die Norm gilt für IVD-Reagenzien, die Material menschlichen Ursprungs enthalten. Die Norm gilt ebenfalls für IVD-Reagenzien, die mittels biotechnologischer Verfahren hergestellte Materialien oder Materialien tierischen Ursprungs enthalten, insbesondere im Hinblick auf relevante Zoonosen, wenn die Ergebnisse einer Risikoanalyse zeigen, dass ein Infektionsrisiko für Menschen besteht.
Die Norm gilt nicht für
¾ Geräte und Probengefäße;
ANMERKUNG 1   Die Verhütung einer Infektion durch Handhabung biologischer Materialien mittels solcher Ausrüstungsgegenstände wird in anderen relevanten Internationalen und/oder Europäischen Normen angesprochen.
¾ allgemeine Gesichtspunkte des Arbeitsschutzes;
¾ Transport von infektiösen Materialien;
¾ Entsorgungsmaßnahmen.
ANMERKUNG 2   Einige der wichtigsten Dokumente, die sich auf von dieser Norm nicht erfasste Aspekte beziehen, sind zur Information in den Literaturhinweisen aufgelistet.

Elimination ou réduction du risque d'infection relatif aux réactifs de diagnostic in vitro

La présente Norme européenne spécifie les exigences relatives à la conception et la fabrication afin de maîtriser efficacement le risque d'infection inhérent aux réactifs de diagnostic in vitro, y compris les produits réactifs, étalons, matériels de contrôle et trousses de réactifs, appelés ci-après réactifs DIV. La présente norme s'applique aux réactifs de diagnostic in vitro contenant des matières d'origine humaine. Elle est également applicable aux réactifs de diagnostic in vitro contenant des matières obtenus par des processus de biotechnologie ou des matières d'origine animale, particulièrement dans l'optique de zoonoses significatives, lorsque les résultats d'une analyse des risques révèlent l'existence d'un risque d'infection humaine.
La norme ne s'applique pas aux éléments suivants :
¾ instruments et matériel de collecte de prélèvements ;
NOTE 1   La prévention des infections provoquées par la manipulation de matières biologiques au moyen de ces équipements est abordée dans d'autres normes internationales et/ou européennes appropriées.
¾ aspects généraux concernant la protection des travailleurs ;
¾ transport des produits infectieux ;
¾ mesures d'élimination.
NOTE 2   Certains des documents les plus pertinents concernant les aspects non couverts par la présente norme sont énumérés dans la bibliographie à titre d'information.

Izločitev ali zmanjšanje tveganja okužbe v povezavi z diagnostičnimi reagenti in vitro

General Information

• Status: Published
• Publication Date: 07-May-2002
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 2 - Quality systems for IVD MDs
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 20-Feb-2020
• 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
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 13641:2002 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elimination or reduction of risk of infection related to in vitro diagnostic reagentsYLWURElimination ou réduction du risque d'infection relatif aux réactifs de diagnostic in vitroEliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehenden InfektionsrisikosTa slovenski standard je istoveten z:EN 13641:2002SIST EN 13641:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13641:200201-november-2002







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13641May 2002ICS 11.100English versionElimination or reduction of risk of infection related to in vitrodiagnostic reagentsElimination ou réduction du risque d'infection relatif auxréactifs de diagnostic in vitroEliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehendenInfektionsrisikosThis European Standard was approved by CEN on 5 January 2002.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 13641:2002 E



EN 13641:2002 (E)2ForewordThis document EN 13641:2002 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnosticmedical devices", 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 November 2002, and conflicting national standards shall be withdrawn at the latestby November 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 13641:2002 (E)3IntroductionAlthough medical laboratory staff routinely handle specimens that are potentially infectious and appropriateprotective measures and safety procedures have to be followed, according to the provisions of theDirective 98/79/EC on in vitro diagnostic medical devices (IVD MDs) (see Bibliography, [1]) the additional risk ofaccidental infection caused by IVD MDs containing infectious or potentially infectious material is to be reduced to aminimum. This requirement of the EU Directive is an essential requirement relating to the design and manufactureof IVD MDs. Manufacturers are obliged to ensure by appropriate design features and manufacturing proceduresthat the risk of infection presented by the product itself is minimal. The EU Directive does not specifically addressthe following aspects which are covered by specific international, European and/or national legislation:– general aspects of workers' protection and the measures that have to be implemented when infectious orpotentially infectious materials are handled in laboratories or manufacturing sites,– transportation of infectious goods,– disposal routes and processes.



EN 13641:2002 (E)41ScopeThis European Standard specifies requirements related to design and manufacture in order to effectively controlthe risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materialsand kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containingmaterial of human origin. The standard is also applicable to in vitro diagnostic reagents containing materialsobtained by biotechnology pr
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