Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE   External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-Diagnostik

Diese Europäische Norm gilt für externe Qualitätssicherungsprogramme, nachfolgend als EQAS (External Quality Assessment Schemes) bezeichnet, die in ihre Funktionen die Beurteilung und Bewertung der Leistung bestimmter in vitro diagnostischer Verfahren (einschließlich der In vitro Diagnostika, nachfolgend als IVD bezeichnet) einbeziehen. Sie legt die Anforderungen dar, die erforderlich sind, damit die EQAS diese Funktion in Beziehung auf Folgendes erfüllen können:
¾   die Struktur und die Organisation des Programms;
¾   die Identitätsfestlegung der vom Teilnehmer verwendeten Verfahren bzw. IVD;
¾   die Gliederung und Bewertung der Daten.
ANMERKUNG   Die entsprechend diesen Kriterien gewonnenen externen Qualitätssicherungsdaten helfen Herstellern, Anwendern oder zuständigen Behörden, die Leistung von IVD nach deren Markteinführung unabhängig zu überwachen.
Diese Europäische Norm legt weder die Art und Weise fest, nach denen die EQAS ihrerseits organisiert werden, noch wie die einzelne oder gemeinsame Leistung klinischer Laboratorien bewertet wird.

Utilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitro

La présente Norme européenne s'applique aux programmes d'évaluation externe de la qualité, désignés ci-après PEEQ, qui incluent dans leurs fonctions l'évaluation de la performance de procédures spécifiées de diagnostic in vitro (y compris les dispositifs médicaux de diagnostic in vitro, désignés ici DM DIV). Elle établit les exigences nécessaires pour permettre aux PEEQ de remplir cette fonction, relatives à :
¾   la conception et l'organisation du programme ;
¾   l'identification des procédures (DM DIV) utilisées par le participant ;
¾   la classification et l'évaluation des données.
NOTE   Les données d'évaluation externe de la qualité générées selon ces critères peuvent aider les fabricants, les utilisateurs et les autorités compétentes à contrôler de manière indépendante la performance post-commercialisation des DM DIV.
La présente Norme européenne ne précise pas la manière dont les PEEQ sont eux-mêmes organisés, ni comment la performance individuelle ou collective des laboratoires d'analyses de biologie médicale est évaluée.

Uporaba shem zunanje ocene kakovosti za oceno delovanja postopkov diagnostičnih preiskav in vitro

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-DiagnostikUtilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitroUse of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN 14136:2004SIST EN 14136:2004en,fr,de01-november-2004SIST EN 14136:2004SLOVENSKI

SIST EN 14136:2004

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14136May 2004ICS 11.100English versionUse of external quality assessment schemes in the assessmentof the performance of in vitro diagnostic examination proceduresUtilisation des programmes d'évaluation externe de laqualité dans l'évaluation de la performance des procéduresde diagnostic in vitroVerwendung externer Qualitätssicherungsprogramme beider Bewertung der Durchführung vonUntersuchungsverfahren in der In-vitro-DiagnostikThis European Standard was approved by CEN on 2 March 2004.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 Central Secretariat 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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14136:2004: ESIST EN 14136:2004

EN 14136:2004 (E)2ForewordThis document (EN 14136:2004) 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 2004, and conflicting national standards shall be withdrawn at the latestby November 2004.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 document 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, Cyprus, Czech Republic, Denmark,Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.SIST EN 14136:2004

EN 14136:2004 (E)3IntroductionExternal quality assessment schemes (EQAS) are an essential feature of mechanisms designed to maintain andimprove the analytical quality and medical appropriateness of clinical laboratory data. EQAS are most highlydeveloped in fields in which mostly quantitative, numerical data are generated; notably in clinical chemistry,haematology, immunology, etc. However, EQAS can also be extended to qualitative or more subjectiveinvestigations such as in microbiology and parasitology, as well as in histo- or cytopathology.Participation and acceptable performance in EQAS serve a valuable function in raising standards in laboratorymedicine and in educating providers and users about the potential benefits and limitations of laboratoryexaminations. Objective data provided by EQAS are an essential component of efforts to relate the current state ofthe art of laboratory performance to medical needs.EQAS are already essential parts of laboratory accreditation systems, whether mandatory or not, in member statesof the European Union. Good clinical laboratory practice includes both external quality assessment and internalquality control as complementary components of quality assurance.In addition to the major objectives of EQAS (see ISO/IEC

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