EN 13975:2003
(Main)Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body.
Two different provisions are addressed:
a) verification by testing attributes and/or variables on a statistical basis;
b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control.
This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.
Probenahmeverfahren für die Annahmeprüfung von In-vitro-Diagnostika - Statistische Aspekte
Diese Europäische Norm legt Anforderungen an Probenahmeverfahren für die Annahmeprüfung fertiger In-vitro-Diagnostika fest, die einer EG-Prüfung durch eine benannte Stelle bedürfen.
Dabei werden zwei verschiedene Bestimmungen berücksichtigt:
a) Prüfung durch statistische Kontrolle von Attributen und/oder Variablen;
b) Prüfung und Kontrolle einer homogenen Charge, die durch geeignete Prozessvalidierung und prozessinterne Kontrollmaßnahmen festgelegt ist.
Diese Norm legt Anforderungen und Kriterien für die Prüfungen fest, durch welche die Homogenität von Prozessen und Produkten nachgewiesen und kontrolliert wird. Diese Norm gilt auch für die Erstellung von Stichprobenplänen für Fertigprodukte nach den Bestimmungen für Produktzertifizierungs-programme und Qualitätsmanagementsysteme des Herstellers.
Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
La présente Norme Européenne spécifie des exigences relatives aux procédures d'échantillonnage à appliquer pour les essais pour acceptation des dispositifs médicaux de diagnostic in vitro qui nécessitent une vérification CE par un organisme notifié.
Deux dispositions différentes sont abordées :
a) la vérification par un contrôle par attributs et/ou variables, sur une base statistique ;
b) la vérification par le contrôle d'un lot homogène ayant été défini par une validation des processus et un moyen adapté de contrôle en cours de fabrication.
La présente norme fixe des exigences et des critères relatifs aux procédures d'essai qui visent à établir et vérifier l'homogénéité des processus et des produits. Elle est également applicable à l'élaboration de plans d'échantillonnage destinés aux produits finis, conformes aux exigences fixées dans les systèmes de qualité de la production et de certification des produits, appliqués par les fabricants.
Postopki vzorčenja, ki se uporabljajo pri preskusih sprejema in vitro diagnostičnih pripomočkov – Statistični vidiki
General Information
Overview
EN 13975:2003 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - provides requirements and guidance for designing and applying sampling procedures for acceptance testing of finished in vitro diagnostic (IVD) medical devices requiring EC verification by a notified body. The standard addresses two primary routes for verification: statistical verification (inspection by attributes and/or variables) and verification of homogeneous batches established by process validation and in‑process control. EN 13975:2003 supports Annex VI of Directive 98/79/EC and is intended for use within manufacturers’ production quality systems and by notified bodies performing EC verification.
Key topics and requirements
- Scope and applicability: Sampling procedures for acceptance testing of finished IVDs, and criteria for establishing product/process homogeneity.
- Two verification approaches:
- Statistical verification using sampling plans by attributes or variables.
- Verification based on demonstrated homogeneity through process validation and in‑process control.
- Standards referenced: Sampling plans should be taken from established standards such as ISO 2859 (attributes) and ISO 3951 (variables). EN 13975 requires manufacturers to specify probabilities of acceptance and acceptable quality (AQL or LQ).
- Sampling plan documentation: If deviating from referenced standards, manufacturers must document the statistical basis, operating characteristic (OC) curve/table, sampling strategy, sample sizes and acceptance criteria.
- Validation and process control: Emphasis on process validation, monitoring, and verification that manufacturing yields homogeneous batches; requirements to justify sampling plan reductions based on historical data.
- Statistical process control (SPC): Use of SPC for variables/attributes (small subgroup sizes commonly 2–5) to demonstrate process stability and capability.
- 100% verification and other controls: Guidance on 100% verification and other process-control methods where appropriate; describes when final testing of finished devices can be reduced or omitted.
Practical applications and users
Who uses EN 13975:2003:
- IVD manufacturers - to design sampling plans, validate processes, and demonstrate batch homogeneity for product certification and production quality systems.
- Notified bodies - for EC verification and assessment of manufacturers’ sampling strategies.
- Quality assurance, regulatory affairs, and production engineers - for establishing operational quality control plans integrating SPC, process validation and final testing. Practical uses:
- Developing compliant sampling plans for lot acceptance.
- Justifying reduced or targeted final testing where robust in‑process control exists.
- Documenting statistical rationale when non‑standard sampling plans are proposed.
Related standards
- ISO 2859‑1/2/3 - Sampling procedures for inspection by attributes (AQL / LQ / skip‑lot).
- ISO 3951 - Sampling procedures and charts for inspection by variables.
- EN ISO 9000 series - Quality management and validation/verification terminology.
- Directive 98/79/EC, Annex VI - EC verification requirements for IVDs.
Keywords: EN 13975:2003, sampling procedures, acceptance testing, in vitro diagnostic medical devices, statistical verification, process validation, notified body, ISO 2859, ISO 3951, AQL, batch homogeneity.
Frequently Asked Questions
EN 13975:2003 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects". This standard covers: This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.
This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.
EN 13975:2003 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 13975:2003 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.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspectsProcédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiquesProbenahmeverfahren für die Annahmeprüfung von In-vitro-Diagnostika - Statistische AspekteTa slovenski standard je istoveten z:EN 13975:2003SIST EN 13975:2003en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13975:200301-september-2003
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13975March 2003ICS 11.100English versionSampling procedures used for acceptance testing of in vitrodiagnostic medical devices - Statistical aspectsProcédures d'échantillonnage utilisées pour l'acceptationdes essais des dispositifs médicaux de diagnostic in vitro -Aspects statistiquesProbenahmeverfahren für die Annahmeprüfung von In-vitro-Diagnostika - Statistische AspekteThis European Standard was approved by CEN on 14 November 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,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13975:2003 E
is measured in a sample of units of product, eithercomponents or finished devices, to establish statistically the acceptability of a batch3.8limiting qualityLQwhen a batch is considered in isolation, a quality level which for the purposes of sampling inspection is limited to alow probability of acceptance[ISO 2859-1:1999]3.9sampleone or more units of product, either components or finished devices, drawn from a batch without regard to thequality of the units3.10sample sizenumber of units of product in the sample3.11sampling planplan that indicates the number of units of product, either components or finished devices, from each batch which isto be drawn for inspection and the associated criteria for determining the acceptability of the batch
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La norme SIST EN 13975:2003 constitue un cadre essentiel pour les procédures d'échantillonnage utilisées lors des tests d'acceptation des dispositifs médicaux de diagnostic in vitro. Elle se concentre sur des aspects statistiques qui favorisent la qualité et la conformité des produits au sein du marché européen. Le champ d'application de cette norme est clairement défini, établissant des exigences pour les procédures d'échantillonnage lors des tests d'acceptation des dispositifs médicaux, nécessitant une vérification par un organisme notifié de l'UE. Les deux dispositions clés traitées par la norme permettent de garantir une évaluation rigoureuse des produits. La première provision offre un cadre pour la vérification par des tests d'attributs et/ou de variables sur une base statistique, ce qui est crucial pour assurer que les dispositifs respectent les critères de qualité requis. La seconde provision se concentre sur la vérification d'un lot homogène, défini par des moyens appropriés de validation des processus et de contrôle en cours de processus. Les points forts de la norme résident dans sa capacité à établir des critères précis pour les procédures de test, garantissant ainsi l'homogénéité des processus et des produits. Cela est particulièrement pertinent pour l'élaboration de plans d'échantillonnage pour les produits finis, en conformité avec les exigences de certification des produits des fabricants et des systèmes de qualité de production. En somme, la norme SIST EN 13975:2003 joue un rôle fondamental dans le secteur des dispositifs médicaux en diagnostic in vitro, en fournissant des lignes directrices claires et des exigences précises qui renforcent la confiance des utilisateurs dans la qualité et la sécurité des dispositifs proposés.
The EN 13975:2003 standard presents a comprehensive framework for sampling procedures essential for acceptance testing of finished in vitro diagnostic medical devices. The scope of this European Standard encompasses critical aspects of performance verification requirements that are pivotal for ensuring compliance with EU regulations by a notified body. One of the primary strengths of the EN 13975:2003 standard lies in its dual provision approach. It effectively addresses both testing attributes and variables on a statistical basis, facilitating robust statistical methodologies for validation. This allows manufacturers to implement quantitative assessments that ensure the reliability and accuracy of their diagnostic devices. Additionally, the standard’s emphasis on verification through the analysis of a homogeneous batch, underscored by stringent process validation and in-process controls, enhances the operational quality of manufacturing processes. Moreover, the standard’s detailed specification of requirements and criteria for testing procedures is an invaluable asset. By establishing guidelines for assessing homogeneity within both processes and products, EN 13975:2003 aids manufacturers in developing effective sampling plans that comply with the necessary product certification and production quality system protocols. This not only improves the likelihood of successful market entry but also promotes the ongoing safety and efficacy of in vitro diagnostic medical devices. Overall, EN 13975:2003 stands out as a relevant and significant standard in the landscape of medical device regulation, providing essential statistical guidelines and rigorous protocols that align with current manufacturing and quality assurance practices in the industry.
Die Norm EN 13975:2003 bietet einen wesentlichen Beitrag zur Standardisierung von Prüfverfahren für In-vitro-Diagnostikgeräte, insbesondere in Bezug auf die Annahmeprüfungen, die von einer benannten Stelle in der EU verifiziert werden müssen. Die Reichweite dieser Norm umfasst detaillierte Anforderungen an die Probenahme, die für die Akzeptanzprüfung dieser Geräte erforderlich sind. Ein wesentlicher Vorteil dieser Norm ist die klare Unterscheidung zwischen zwei Prüfmethoden: Zum einen die Verifikation durch die statistische Prüfung von Attributen und/oder Variablen und zum anderen die Verifikation durch die Prüfung einer homogenen Charge, die durch geeignete Verfahren zur Prozessvalidierung und In-Prozess-Kontrolle definiert wurde. Diese beiden Ansätze verdeutlichen die Flexibilität der Norm und ermöglichen es den Herstellern, je nach spezifischem Bedarf und Produktionsprozess die geeignete Methode auszuwählen. Die Norm legt zudem spezifische Anforderungen und Kriterien für die Testverfahren fest, um die Homogenität von Prozessen und Produkten zu gewährleisten. Dies ist besonders wichtig, da die Homogenität entscheidend für die Qualität und Zuverlässigkeit von In-vitro-Diagnostikgeräten ist. Die Fähigkeit, genaue und reproduzierbare Ergebnisse zu liefern, ist von zentraler Bedeutung für die Sicherheit und Effektivität von medizinischen Diagnosen. Darüber hinaus ist die Norm auch für die Erstellung von Probenahmeplänen für Fertigprodukte anwendbar, was für Hersteller von entscheidender Bedeutung ist, um den Anforderungen an die Produktzertifizierung und die Produktionsqualität gerecht zu werden. Durch die Integration von statistischen Überlegungen in die Probenahmeverfahren unterstützt die EN 13975:2003 die Qualitätssicherung und fördert die Einhaltung der europäischen Vorschriften für medizinische Geräte. Insgesamt zeigt die EN 13975:2003 eine hohe Relevanz und bietet wichtige Leitlinien für die Probenahme und Prüfung von Fertigprodukten im Bereich der In-vitro-Diagnostik, was zur Sicherstellung der Qualität und Zuverlässigkeit von medizinischen Diagnosesystemen beiträgt.
SIST EN 13975:2003 표준은 체외 진단 의료 기기의 수용 테스트를 위한 샘플링 절차 요구사항을 명확히 규정하고 있습니다. 이 표준은 유럽 연합 인증을 요구하는 완성된 체외 진단 의료 기기에 대해 적용되며, 인증 기관의 검사와 관련하여 중요한 역할을 합니다. 이 표준의 강점 중 하나는 통계적 방법론을 바탕으로 한 두 가지 다른 검증 조항을 제공한다는 점입니다. 첫 번째는 특성 및/또는 변수 테스트를 통한 검증이며, 두 번째는 적절한 공정 검증 및 공정 관리 수단에 의해 정의된 균질한 배치의 검증입니다. 이러한 다양성은 의료 기기의 품질 관리와 일관성을 확보하는 데 중요한 역할을 합니다. SIST EN 13975:2003은 프로세스와 제품의 균질성을 확립하고 검증하기 위한 테스트 절차에 대한 요구사항과 기준을 규정하고 있습니다. 이 표준은 제조업체의 제품 인증 및 생산 품질 시스템에 적합한 완제품 샘플링 계획을 수립하기 위해 매우 중요합니다. 이를 통해 제조업체는 자신들의 제품이 정확하고 일관된 품질을 유지할 수 있도록 지원받게 됩니다. 결국 이 표준은 체외 진단 의료 기기의 품질 인증 과정에서 필수 불가결한 요소로 자리 잡고 있으며, 해당 분야에서의 신뢰성을 더욱 높이는 데 기여하고 있습니다.
EN 13975:2003は、医療機器の受入試験におけるサンプリング手続きに関する欧州標準であり、特に体外診断用医療機器の完成品に関連しています。この標準は、通知機関によるEU認証が必要な製品に対して適用されるもので、サンプリング手続きの要件を明確に示しています。 この標準の主な強みは、サンプリング手続きに関する具体的かつ実用的なガイドラインを提供している点です。特に、統計的な基準に基づく属性および変数のテストによる確認や、適切なプロセスバリデーションや工程管理によって定義された均質なバッチをテストすることに関する二つの異なる規定が記載されています。これにより、製品の均質性とプロセスの一貫性が確保されるため、製品の品質が保証されます。 さらに、EN 13975:2003は、製品認証や生産品質システムにおける製造者の要件に応じたサンプリングプランの策定にも適用可能です。これにより、製造者は適切なサンプリング手続きを計画・実施し、製品の品質基準を満たすことができます。このことは、医療機器の業界において、信頼性のある製品を市場に提供するために極めて重要です。 この標準は、医療機器産業の充実した品質保証を実現するための不可欠な指針であり、その関連性は、医療機器の安全性と有効性を確保する上でますます高まっています。特に、EU市場における規制遵守が求められる中、EN 13975:2003は避けて通れない基準であり、メーカーにとっても重要な役割を果たしています。
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