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
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
EN 13975:2003 (E)2ForewordThis document (EN 13975:2003) has been prepared by Technical Committee CEN /TC 140, "In vitro diagnosticmedical devices" the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 2003, and conflicting national standards shall be withdrawn at thelatest by September 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.Annex A is informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
EN 13975:2003 (E)3IntroductionThis European Standard relates to Annex VI "EC VERIFICATION" of the Directive 98/79/EC of the EuropeanParliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, setting out requirementsfor sampling procedures used for acceptance testing of in vitro diagnostic medical devices by a notified body.In Annex VI three provisions for verification are described:¾ Section 5 provides for verification by examination and testing of every finished device;¾ Section 6.3 provides for verification based on statistical control by attributes and/or variables;¾ Section 2.2 provides for alternative conformity assessment procedures for those situations where statisticalverification as specified in Section 6.3 is considered to be not appropriate.The first provision is not considered in the present standard since the associated sampling plan requires nostatistical considerations.The second provision is applied when sufficient certainty on the result of such verification on finished devices canbe gained by a sampling plan established on a statistical basis. For this purpose existing standards on acceptancetesting can be applied.The third provision is addressed in Section 2.2 of Annex VI which states that:"To the extent that for certain aspects the final testing according to Section 6.3 is not appropriate, adequatein-process testing, monitoring and control methods shall be established by the manufacturer with the approval ofthe notified body. The provision of Annex IV, Section 5, shall apply accordingly in relatio
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