In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used  to preserve samples or to initiate reactions for further processing of the sample in the collection device.  
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
       the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
       the establishment of stability of the IVD reagent in use after the first opening of the primary container;
       the monitoring of stability of IVD reagents already placed on the market;
       the verification of stability specifications after modifications of the IVD reagent that might affect stability.

In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011)

Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro (ISO 23640:2011)

L'ISO 23640:2011 s'applique à l'évaluation de la stabilité des dispositifs médicaux de diagnostic in vitro, y compris les réactifs, les agents d'étalonnage, les matériaux de contrôle, les diluants, les tampons et les trousses de réactifs, désignés ci-après réactifs de DIV. L'ISO 23640:2011 peut également être appliquée aux dispositifs de collecte d'un prélèvement qui contiennent des substances utilisées pour conserver les échantillons ou pour initier des réactions en vue d'un traitement ultérieur de l'échantillon dans le dispositif de collecte.
L'ISO 23640:2011 spécifie les exigences générales relatives à l'évaluation de la stabilité et précise les exigences spécifiques applicables à l'évaluation de la stabilité en temps réel et accélérée lors du recueil des données, en vue
       d'établir la durée de vie des réactifs de DIV, y compris les conditions de transport de nature à garantir le maintien des spécifications de produit,
       d'établir la stabilité du réactif de DIV en cours d'utilisation après la première ouverture du contenant primaire,
       de surveiller la stabilité des réactifs de DIV déjà mis sur le marché,
       de vérifier les spécifications de stabilité après avoir apporté des modifications au réactif de DIV pouvant affecter la stabilité.

Diagnostični medicinski pripomočki in vitro - Ocena stabilnosti diagnostičnih reagentov in vitro (ISO 23640:2011)

Standard ISO 23640:2011 se uporablja za oceno stabilnosti diagnostičnih medicinskih pripomočkov in vitro, vključno z reagenti, kalibratorji, kontrolnimi materiali, redčili, pufri in kiti reagentov, ki se v nadaljevanju imenujejo diagnostični reagenti in vitro (IVD). Standard ISO 23640:2011 se lahko uporablja tudi za naprave za zbiranje preskušancev, ki vsebujejo snovi za ohranjanje vzorcev ali za sprožitev reakcij za nadaljnjo obdelavo vzorca v napravi za zbiranje.
Standard ISO 23640:2011 določa splošne zahteve za oceno stabilnosti in podaja posebne zahteve za oceno stabilnosti v realnem času in pospešeno oceno stabilnosti, ko se zbirajo podatki za:
– določanje roka uporabe diagnostičnega reagenta in vitro (IVD), vključno s prevoznimi pogoji, primernimi za zagotavljanje, da se ohranijo specifikacije proizvoda;
– določanje stabilnosti diagnostičnega reagenta in vitro, ki je v uporabi po prvem odpiranju primarne posode;
– spremljanje stabilnosti diagnostičnih reagentov in vitro, ki so že na trgu;
– preverjanje specifikacij stabilnosti po spremembah diagnostičnega reagenta in vitro, ki bi lahko vplivale na stabilnost.

General Information

Status
Published
Publication Date
09-Jun-2015
Withdrawal Date
29-Jun-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
10-Jun-2015
Completion Date
10-Jun-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23640:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 23640:2013
'LDJQRVWLþQLPHGLFLQVNLSULSRPRþNLLQYLWUR2FHQDVWDELOQRVWLGLDJQRVWLþQLK
UHDJHQWRYLQYLWUR ,62
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
(ISO 23640:2011)
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische
Untersuchungen (ISO 23640:2011)
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de
diagnostic in vitro (ISO 23640:2011)
Ta slovenski standard je istoveten z: EN ISO 23640:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 23640:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23640:2015

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SIST EN ISO 23640:2015

EUROPEAN STANDARD
EN ISO 23640

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.100.10 Supersedes EN ISO 23640:2013
English Version
In vitro diagnostic medical devices - Evaluation of stability of in
vitro diagnostic reagents (ISO 23640:2011)
Dispositifs médicaux de diagnostic in vitro - Évaluation de la In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien
stabilité des réactifs de diagnostic in vitro (ISO 23640:2011) für in-vitro-diagnostische Untersuchungen (ISO
23640:2011)
This European Standard was approved by CEN on 3 June 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23640:2015 E
worldwide for CEN national Members.

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SIST EN ISO 23640:2015
EN ISO 23640:2015 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC .4

2

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SIST EN ISO 23640:2015
EN ISO 23640:2015 (E)
Foreword
The text of ISO 23640:2011 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory
testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has
been taken over as EN ISO 23640:2015 by Technical Committee CEN/TC 140 “In vitro diagnostic medical
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 or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn
at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 23640:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below appli
...

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