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: 18-Mar-2003
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 2 - Quality systems for IVD MDs
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 20-Feb-2020
• 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: SIST EN 13975:2003 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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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