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
04-Aug-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
07-Jul-2015
Due Date
11-Sep-2015
Completion Date
05-Aug-2015

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SLOVENSKI STANDARD
SIST EN ISO 23640:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 23640:2013
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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

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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 applies. For

dated references, only the edition cited applies. However, for any use of this standard ‘within the meaning of

Annex ZA’, the user should always check that any referenced document has not been superseded and that its

relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative

reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC

standard, as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in

whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected
version 2007-10-01

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 23640:2015 without any modification.

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SIST EN ISO 23640:2015
EN ISO 23640:2015 (E)
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 a means of conforming to Essential Requirements of

Directive 98/79/EC 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.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be reduced ‘as far

as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the

corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Directive 98/79/EC

Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/notes

of Directive 98/79/EC
4.1, 4.2, 4.3, 5.1, 5.2, 5.3 A.4 This Standard covers stability
evaluations of diverse transport,
storage and use conditions that
are foreseen by the IVD
manufacturer based on the
intended purpose and the
anticipated use of the device. In
case of self-testing devices, the
tested conditions should reflect the
normal routine conditions of use by
a lay-user.
Particular storage, transport and/or
handling conditions must be
specified by the IVD manufacturer
as provided on the label and in the
instructions for use.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
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SIST EN ISO 23640:2015
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
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SIST EN ISO 23640:2015
ISO 23640:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011

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
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
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SIST EN ISO 23640:2015
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 2011 – All rights reserved iii
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SIST EN ISO 23640:2015
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
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SIST EN ISO 23640:2015
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 stab
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