EN 14136:2004
(Main)Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
General Information
- Abstract
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.
- Status
- Published
- Publication Date
- 18-May-2004
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140/WG 9 - Use of external quality assessment schemes
- Current Stage
- 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
- Start Date
- 02-Sep-2025
- Completion Date
- 02-Sep-2025
- Directive
- Not Harmonized98/79/EC - In vitro diagnostic medical devicesOJ Ref: C, C 16 OJ Date: 18-Jan-2011
Overview
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 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
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
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
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.
Keywords: 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
Relations
- Effective Date
- 25-Aug-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 14136:2004 is a standard published by the European Committee for Standardization (CEN). Its full title is "Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures". This standard covers: 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.
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.
EN 14136:2004 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14136:2004 has the following relationships with other standards: It is inter standard links to ISO 3534-1:1993, EN ISO 17511:2021, EN 1720:1998, EN 12286:1998, EN 375:2001, EN ISO 15195:2019, EN ISO 18153:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14136:2004 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 14136:2004 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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