EN ISO 23640:2013

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)

Diese Internationale Norm gilt für die Haltbarkeitsprüfung von In-vitro Diagnostika, einschließlich Reagenzien, Kalibriermaterialien, Kontrollmaterialien, Verdünnungsmitteln, Pufferlösungen und Reagens Kits, nachstehend IVD Reagenzien genannt. Diese Internationale Norm kann auch für Primärprobensammler gelten, die Substanzen enthalten, die der Haltbarmachung von Proben dienen oder mit denen Reaktionen zur weiteren Behandlung der Probe in dem Sammler angeregt werden.
Diese Internationale Norm legt allgemeine Anforderungen an die Haltbarkeitsprüfung fest und enthält spezielle Anforderungen an die Echtzeit  und beschleunigte Haltbarkeitsprüfung für die Gewinnung von Daten:
-   zur Festlegung der Haltbarkeitsdauer von IVD Reagenzien, einschließlich geeigneter Transport-bedingungen, um sicherzustellen, dass die Produktspezifikationen erhalten bleiben;
-   zur Festlegung der Haltbarkeit des in Gebrauch befindlichen IVD Reagens nach dem ersten Öffnen des Primärbehälters;
BEISPIEL   Haltbarkeit im Analysengerät, Haltbarkeit nach Wiederherstellung, Haltbarkeit der geöffneten Ampulle/Flasche;
-   zur Überwachung der Haltbarkeit von bereits in Verkehr gebrachten IVD Reagenzien;
-   zur Bestätigung der Haltbarkeitsangaben nach Änderungen des IVD Reagens, die Einfluss auf dessen Haltbarkeit haben könnten.
Diese Internationale Norm gilt nicht für Instrumente, Apparate, Ausrüstung, Systeme oder Probengefäße oder die zur Untersuchung vorgelegte Probe.

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)

Ta mednarodni standard 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). Ta mednarodni standard 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. Ta mednarodni standard 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. Ta mednarodni standard se ne uporablja za instrumente, aparate, opremo, sisteme ali vsebnike za vzorce ali za vzorec, ki je predmet preiskave.

General Information

• Status: Withdrawn
• Publication Date: 05-Feb-2013
• Withdrawal Date: 09-Jun-2015
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 2 - Quality systems for IVD MDs
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 10-Jun-2015
• 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 ISO 23640:2013 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Relations

• Replaces: EN ISO 23640:2011 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
• Effective Date: 13-Feb-2013
• Replaced By: EN ISO 23640:2015 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
• Effective Date: 24-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2013
1DGRPHãþD
SIST EN ISO 23640:2012
'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 23640:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 23640
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.100.10 Supersedes EN ISO 23640:2011
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 In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien
la stabilité des réactifs de diagnostic in vitro (ISO für in-vitro-diagnostische Untersuchungen (ISO
23640:2011) 23640:2011)
This European Standard was approved by CEN on 8 January 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23640:2013: E
worldwide for CEN national Members.

Contents
Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC . 4

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 23640:2013 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 23640:2011.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 23640:2011 has been approved by CEN as EN ISO 23640:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 98/79/EC on in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 98/79/EC on
in vitro diagnostic medical devices

Clauses/subclauses of this Essential Requirements of the Qualifying remarks/Notes
European Standard Directive 98/79/EC
4.1, 4.2, 4.3, 5.1, 5.2, 5.3 A.4

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 23640
First edition
2011-12-01
In vitro diagnostic medical devices —
Evaluation of stability of in vitro
diagnostic reagents
Dispositifs médicaux de diagnostic in vitro — Évaluation de la stabilité
des réactifs de diagnostic in vitro
Reference number
ISO 23640:2011(E)
©
ISO 2011
ISO 23640:2011(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
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Published in Switzerland
ii © ISO 2011 – All rights reserved

ISO 23640:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 23640 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic
test systems.
ISO 23640:2011(E)
Introduction
One important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents
is initially designing the stability of a product, then determining and verifying the expiry date of the product that is
placed on the market. To determine shelf life, transport stability, and in-use stability, the manufacturer performs
an evaluation. In order to provide this important information to the customer, the manufacturer identifies critical
factors that might influence stability of the IVD reagent and carefully evaluates these characteristics. Stability
of the IVD reagent affects the performance of the device and therefore has an impact on patient results.
It is the manufacturer’s responsibility to determine and monitor stability of IVD reagents to ensure that
performance characteristics of the product are maintained. This is best accomplished by developing a stability
evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport limitations
and in-use stability information, which are then provided to the customers.
[2]
The basis for this ISO standard is EN 13640, Stability testing of in vitro diagnostic reagents .
iv © ISO 2011 – All rights reserved

INTERNATIONAL STANDARD ISO 23640:2011(E)
In vitro diagnostic medical devices — Evaluation of stability of
in vitro diagnostic reagents
1 Scope
This International Standard 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. This
International Standard 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.
This International Standard 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;
EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.
— 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.
This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen
receptacles, or the sample subject to examination.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accelerated stability evaluation
study designed to increase the rate of chemical and/or physical degradation, or change, of an IVD reagent by
using stress environmental conditions to predict shelf life
NOTE The design of an accelerated stability evaluation can include extreme conditions of temperature, humidity, light
or vibration.
3.2
Arrhenius plot
mathematical function that describes the approximate relationship between the rate constant of a chemical
reaction and the temperature and energy of activation
[CLSI EP25-A]
ISO 23640:2011(E)
3.3
batch
lot
defined amount of material that is uniform in its properties and has been produced in one process or series of
processes
[ISO 18113-1:2009, definition 3.5]
3.4
batch code
lot number
distinctive set of numbers and/or letters that specifically identifies a batch and permits its manufacturing,
packaging, labelling and distribution history to be traced
[ISO 18113-1:2009, definition 3.6]
3.5
expiry date
expiration date
upper limit of the time interval during which the performance characteristics of a material stored under specified
conditions can be assured
NOTE Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the
manufacturer based on experimentally determined stability properties.
[ISO 18113-1:2009, definition 3.17]
3.6
IVD medical device
in vitro diagnostic medical device
device, used alone or in combination, intended by the manufacturer for the in vitro examination of specimens
derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility
purposes, which can include reagents, calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus or other articles
[ISO 18113-1:2009, definition 3.27]
3.7
IVD reagent
in vitro diagnostic reagent
chemical, biological or immunological components, solutions or preparations intended by the manufacturer to
be used as an IVD medical device
[ISO 18113-1:2009, definition 3.28]
3.8
real time stability evaluation
study designed to establish or verify the shelf life
...