SIST EN 13641:2002
(Main)Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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
3 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.
3 allgemeine Gesichtspunkte des Arbeitsschutzes;
3 Transport von infektiösen Materialien;
3 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 a 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-apres réactifs DIV. La présente norme s'applique aux réactifs de diagnostic in vitro contenant des matieres d'origine humaine. Elle est également applicable aux réactifs de diagnostic in vitro contenant des matieres obtenus par des processus de biotechnologie ou des matieres d'origine animale, particulierement dans l'optique de zoonoses significatives, lorsque les résultats d'une analyse des risques révelent l'existence d'un risque d'infection humaine.
La norme ne s'applique pas aux éléments suivants :
3 instruments et matériel de collecte de prélevements ;
NOTE 1 La prévention des infections provoquées par la manipulation de matieres biologiques au moyen de ces équipements est abordée dans d'autres normes internationales et/ou européennes appropriées.
3 aspects généraux concernant la protection des travailleurs ;
3 transport des produits infectieux ;
3 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 a titre d'information.
Izločitev ali zmanjšanje tveganja okužbe v povezavi z diagnostičnimi reagenti in vitro
General Information
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 processes or materials of animal origin, in particular in view of relevant zoonoses, whenthe 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 isaddressed 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 inBibliography for information.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. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use.EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.3Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1potentially infectious biological materialmaterial which might contain infectious viable transmissible agents albeit with a low probabilityNOTE
Potentially infectious biological material includes all human and all animal sourced materials, including the specimens forroutine diagnostic examination and biological materials of unknown origin.3.2infectious biological materialmaterial which is known or highly likely to contain viable microorganisms or other transmissible agents which areknown or suspected to cause disease in humansNOTE
Other transmissible agents are e.g. prions.
EN 13641:2002 (E)53.3in vitro diagnostic reagentIVD reagentin vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material or kitNOTE 1
For the definition of an in vitro diagnostic medical device see [1].NOTE 2
In some cases a particular IVD reagent, as defined for use in human medicine, may serve also in veterinary medicine.[EN 375:2001]4Requirements related to design and manufacture4.1GeneralIn order to eliminate or reduce to a minimum the risk of infection related to IVD reagents the following aspects shallbe considered:– rationale for using infectious or potentially infectious biological material;– sourcing and testing requirements (stipulated in material specifications);– inactivation or other appropriate measures to reduce the risk of infection;– warnings to b
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