SIST EN 13975:2003

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

• Status: Published
• Publication Date: 31-Aug-2003
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2003
• Due Date: 01-Sep-2003
• Completion Date: 01-Sep-2003
• 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 13975:2003 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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.

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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