SIST EN 14136:2004

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

General Information

• Status: Published
• Publication Date: 31-Oct-2004
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Nov-2004
• Due Date: 01-Nov-2004
• Completion Date: 01-Nov-2004
• 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: EN 14136:2004 - Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

Overview

SIST EN 14136:2004 is a European Standard developed by CEN focusing on the use of External Quality Assessment Schemes (EQAS) in evaluating the performance of in vitro diagnostic examination procedures (IVD MDs). This standard sets out essential requirements for EQAS to effectively assess and monitor the post-marketing performance of specific in vitro diagnostic medical devices. It emphasizes scheme design, proper identification of diagnostic procedures, and robust data classification and evaluation.

By following SIST EN 14136:2004, EQAS organizations can support manufacturers, users, and regulatory authorities in independently monitoring IVD MDs. However, the standard does not dictate how EQAS are organized nor how clinical laboratories' performance is evaluated collectively or individually.

Key Topics

• Scope and Purpose
  SIST EN 14136:2004 applies to EQAS that evaluate specific in vitro diagnostic procedures and devices. The goal is to provide independent performance data to ensure the ongoing quality and reliability of diagnostic tests.

• Scheme Design and Organization
  The standard highlights the importance of well-planned EQAS designs, including frequency of surveys (recommended at least six times per year), usage of survey samples closely simulating clinical specimens, and requirements for rapid data processing and clear reporting.

• Identification of Diagnostic Procedures
  EQAS must be able to clearly identify the specific IVD medical devices used by participants and distinguish device-related performance from user-related factors. This enables targeted evaluation of analytical procedures.

• Data Classification and Evaluation
  Statistical methods appropriate for the diagnostic property being tested must be applied. EQAS organizations should report central tendencies, dispersion measures, and provide performance interpretation based on manufacturer claims, applicable metrological standards, and medical relevance.

• Performance Assessment
  Assessment must consider appropriate criteria reflecting medical needs and state-of-the-art diagnostic capabilities. Traceability to reference measurement procedures and adherence to manufacturer protocols ensure reliability of evaluations.

• Quality Management and Independent Operation
  EQAS organizations are required to maintain a quality management system and operate independently without commercial or conflicting interests to guarantee impartiality in performance assessments.

Applications

SIST EN 14136:2004 serves as a valuable framework for:

• Manufacturers of IVD Medical Devices
  Facilitates ongoing post-marketing surveillance of device performance, helping identify issues that may not be apparent during initial validation phases.

• Clinical Laboratories and Healthcare Providers
  Supports participation in quality schemes that promote high standards in laboratory diagnostics and support clinical decision-making.

• Regulatory Authorities and Competent Bodies
  Provides a standardized basis for monitoring and evaluating the analytical quality of diagnostic devices across Europe, supporting compliance with EU regulations such as Directive 98/79/EC.

• External Quality Assessment Organizations
  Offers guidance on designing EQAS that yield meaningful and actionable data related to both laboratory performance and the diagnostic devices themselves.

Related Standards

SIST EN 14136:2004 integrates and complements several key standards including:

• EN ISO 17511 – Metrological traceability of values assigned to calibrators and control materials for IVD devices
• EN ISO 18153 – Metrological traceability for catalytic concentration values of enzymes
• EN 12286 – Presentation of reference measurement procedures for biological samples
• EN ISO 15195 – Requirements for reference measurement laboratories in laboratory medicine
• ISO/IEC Guide 43-1 – General principles for proficiency testing by interlaboratory comparisons

These standards collectively support the establishment of robust quality assurance frameworks for in vitro diagnostics, ensuring accuracy, traceability, and reliability across the diagnostic testing lifecycle.

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Keywords: SIST EN 14136:2004, External Quality Assessment Scheme, EQAS, in vitro diagnostic medical devices, IVD MD, post-marketing surveillance, diagnostic procedure evaluation, quality management system, metrological traceability, laboratory quality assurance, clinical laboratory quality, European Standard, CEN, performance assessment

Standards Content (Sample)

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
STANDARD
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
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