SIST EN 13640:2002
(Main)Stability testing of in vitro diagnostic reagents
Stability testing of in vitro diagnostic reagents
This standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the
- determination of IVD reagent shelf-life including transport stability;
- determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability);
- monitoring of stability of IVD reagents already placed on the market;
- verification of stability after IVD reagent modifications that may affect stability.
This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.
Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen
Diese Norm gilt für die Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen, einschließ-lich Reagenzprodukten, Kalibriermaterialien, Kontrollmaterialien und Kits, nachstehend IVD-Reagenzien genannt. Sie legt allgemeine Anforderungen für die Haltbarkeitsprüfung fest und enthält spezielle Anforderungen an die Echtzeit- und beschleunigte Prüfung für die Gewinnung von Daten zur
3 Bestimmung der Haltbarkeitsdauer von IVD-Reagenzien einschließlich der Transportstabilität;
3 Bestimmung der Haltbarkeit von IVD-Reagenzien in Gebrauch nach dem ersten Öffnen des Primärbe-hältnisses (z. B. Haltbarkeit im Analysengerät);
3 Überwachung der Haltbarkeit von bereits in den Verkehr gebrachten IVD-Reagenzien;
3 Verifizierung der Haltbarkeit nach Änderungen an einem IVD-Reagenz, die Einfluss auf dessen Haltbarkeit haben könnten.
Diese Norm gilt nicht für Geräte, Apparate, Ausrüstung, Systeme oder Probengefäße.
Essais de stabilité des réactifs de diagnostic in vitro
La présente Norme européenne est applicable aux essais de stabilité des réactifs de diagnostic in vitro, y compris les produits réactifs, les étalons, les matériaux de contrôle et les trousses de réactifs, appelés par la suite réactifs DIV. Elle spécifie les exigences générales concernant les essais de stabilité et précise les exigences spécifiques relatives aux essais en temps réel et aux essais accélérés pour générer des données sur la stabilité en vue de :
3 la détermination de la durée de vie des réactifs DIV, y compris la stabilité durant le transport ;
3 la détermination de la stabilité des réactifs DIV utilisés apres la premiere ouverture du contenant primaire (par exemple stabilité sur l'analyseur) ;
3 la surveillance du suivi de la stabilité des réactifs DIV déja mis sur le marché ;
3 la vérification de la stabilité des réactifs DIV apres modifications pouvant affecter cette stabilité.
La présente norme ne s'applique pas aux instruments, appareils, équipements, systemes ou matériel de collecte des prélevements.
Preskus stabilnosti diagnostičnih reagentov in vitro
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Stability testing of in vitro diagnostic reagentsEssais de stabilité des réactifs de diagnostic in vitroHaltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische UntersuchungenTa slovenski standard je istoveten z:EN 13640:2002SIST EN 13640:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13640:200201-november-2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13640March 2002ICS 11.100English versionStability testing of in vitro diagnostic reagentsEssais de stabilité des réactifs de diagnostic in vitroHaltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische UntersuchungenThis European Standard was approved by CEN on 27 December 2001.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,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13640:2002 E
EN 13640:2002 (E)2ForewordThis document EN 13640:2002 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 2002, and conflicting national standards shall be withdrawn at thelatest by September 2002.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.Annexes A and ZA are for information only.This standard includes a Bibliography.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, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 13640:2002 (E)31ScopeThis European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagentproducts, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirementsfor stability testing and gives specific requirements for real-time testing and accelerated testing when generatingstability data in the– determination of IVD reagent shelf-life including transport stability;– determination of stability of the IVD reagent in use after the first opening of the primary container(e. g. on-board stability);– monitoring of stability of IVD reagents already placed on the market;– verification of stability after IVD reagent modifications that may affect stability.This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.2Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.2.1accelerated stability studystability study designed to increase the rate of chemical or physical degradation of an in vitro diagnostic reagent byusing exaggerated conditions with the purpose of predicting the shelf-lifeNOTE
The design of an accelerated study may include elevated temperature, high humidity, light and vibration.2.2batchlotdefined amount of material, either starting material, intermediate or finished product, which is uniform in itsproperties and has been produced in one process or series of processes[EN 375:2001]2.3expiry datedate up to which product performance is assured by the manufacturer based on the stability of the IVD reagent[EN 375:2001]2.4in vitro diagnostic reagentIVD reagentin vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material or kitNOTE 1
For the definition of an in vitro diagnostic medical device see Bibliography.NOTE 2
In some cases a particular IVD reagent, as defined for use in human medicine, may serve also in veterinary medicine.[EN 375:2001]
EN 13640:2002 (E)42.5real-time stability testingexposing the IVD reagent to the conditions anticipated by the manufacturer to which an IVD reagent is exposedduring transportation, storage and use, and investigating robustness and stability under these conditions2.6shelf lifeperiod until expiry date[EN 375 : 2001]2.7stabilityability of an IVD reagent, when kept under specified conditions, to retain throughout the shelf life its properties and/or performance within limits specified by the manufacturer[EN 375 : 2001]3General requirements3.1ProtocolConclusions on IVD reagent stability shall be based on data that are generated in accordance with apre-established protocol including details at least on:– responsibilities;– clear IVD reagent identification;– presumed storage conditions;– objective and purpose of testing;– information about the samples (e.g. number of batches, amount , container, identification);– storage conditions recommended for the samples
(e.g. frozen, refrigerated, room temperature);– simulation of transport as appropriate;– intervals between
examinations;– examinations to be performed at the end of each interval (e. g. procedure and extent of testing);– stability criteria to be met;– interpretation of data.3.2Final reportA final report shall be prepared to complete each study. This report shall at least include or refer to– the protocol which was followed;– the batch(es) involved;– all testing results obtained;
EN 13640:2002 (E)5– summary and conclusions regarding stability.The final report shall be part of the technical documentation related to the IVD reagent.4Procedures4.1GeneralStability assessment shall in principle be based on data derived from real-time testing. Depending on the riskassociated with the IVD reagent, data derived from accelerated testing as well as experience gained with similarIVD reagents that can reasonably be expected to be comparable as regards their stability profile may also be takeninto account. If at the time of placing an IVD reagent onto the market, stability claims are based on such previousdata, these data shall be subsequently verified by real-time testing.Testing may be performed on any IVD reagent batch provided that the manufacturing conditions do not essentiallydiffer from the routine production conditions.To cover remaining un
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