oSIST prEN ISO 23640:2026

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026)

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/DIS 23640:2026)

Diese Internationale Norm gilt für die Haltbarkeitsprüfung von In vitro-Diagnostika, einschließlich Reagenzien, Kalibriermaterialien, Kontrollmaterialien, Verdünnungsmitteln, Pufferlösungen und Reagenz-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 Transportbedingungen, um sicherzustellen, dass die Produktspezifikationen erhalten bleiben;
   zur Festlegung der Haltbarkeit des in Gebrauch befindlichen IVD-Reagenz 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-Reagenz, 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/DIS 23640:2026)

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.

In vitro diagnostične medicinske naprave - Vrednotenje stabilnosti in vitro diagnostičnih reagentov (ISO/DIS 23640:2026)

ISO 23640:2011 se uporablja za ocenjevanje stabilnosti in vitro diagnostičnih medicinskih pripomočkov, vključno z reagenti, kalibratorji, kontrolnimi materiali, razredčili, pufri in kompleti reagentov, v nadaljevanju imenovanimi IVD reagenti. ISO 23640:2011 se lahko uporablja tudi za naprave za zbiranje vzorcev, ki vsebujejo snovi za ohranjanje vzorcev ali za začetek reakcij za nadaljnjo obdelavo vzorca v napravi za zbiranje.
ISO 23640:2011 določa splošne zahteve za ocenjevanje stabilnosti in podaja posebne zahteve za ocenjevanje stabilnosti v realnem času in pospešeno ocenjevanje stabilnosti pri ustvarjanju podatkov za:
- določitev roka uporabnosti IVD reagentov, vključno s pogoji prevoza, ki zagotavljajo ohranitev specifikacij izdelka;
- določitev stabilnosti IVD reagenta v uporabi po prvem odprtju primarne posode;
- spremljanje stabilnosti IVD reagentov, ki so že na trgu;
- preverjanje specifikacij stabilnosti po spremembah IVD reagenta, ki bi lahko vplivale na stabilnost.

General Information

• Status: Not Published
• Public Enquiry End Date: 28-Jul-2026
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 15-May-2026
• Due Date: 02-Oct-2026
• Directive: Harmonized Standard2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: prEN ISO 23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026)

Relations

• Revises: SIST EN ISO 23640:2015 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
• Effective Date: 13-Mar-2024

Overview

oSIST prEN ISO 23640:2026 is a key international standard that specifies the general and specific requirements for the evaluation of stability of in vitro diagnostic (IVD) reagents. Developed by the Slovenian Institute for Standardization (SIST), this standard adopts ISO/DIS 23640:2026 and is aligned with regulatory frameworks such as the EU Regulation (EU) 2017/746 for IVD medical devices.

The standard applies to stability evaluation processes for IVD reagents-including reagents, calibrators, control materials, diluents, buffers, reagent kits, and specimen collection devices that contain substances to preserve or react with samples. It focuses on maintaining product performance specifications throughout the product's intended shelf life, transport, and in-use period.

Key Topics

• Stability Evaluation Protocols: oSIST prEN ISO 23640:2026 describes the development, execution, and documentation of stability evaluation studies to establish and verify shelf life, transport, and in-use stability of IVD reagents.
• Real-time and Accelerated Testing: The standard defines methodologies for real-time stability testing (normal conditions) and accelerated stability testing (exaggerated conditions) to support claims about reagent expiration and usability.
• Technical Documentation Requirements: Guidance is provided for stability reports, including protocol adherence, test results, batch tracking, storage conditions, and justifications of deviations or modifications.
• Regulatory Alignment: Supports conformity with mandatory European regulations, notably the General Safety and Performance Requirements of Regulation (EU) 2017/746, providing confidence for regulatory approval and market surveillance.

Applications

oSIST prEN ISO 23640:2026 is essential for:

• Medical Device Manufacturers: Ensuring that IVD reagents and associated specimen collection devices consistently meet stability requirements, supporting claims made in product labeling and technical files.
• Quality Assurance Teams: Establishing evidence-based shelf life, monitoring in-use and post-market reagent performance, and integrating risk management in reagent lifecycle assessments.
• Regulatory Affairs: Demonstrating conformity with EU and international regulatory requirements for IVD devices, which facilitates market access and compliance with post-market surveillance obligations.
• Clinical Laboratories: Selecting reagents and kits with verifiable stability data, increasing reliability and accuracy in testing results for patient safety.
• Product Development: Guiding formulation, packaging, and handling decisions based on stability data, which supports rapid innovation and efficient product lifecycle management.

Benefits

• Promotes patient safety and reliable diagnostic results by validating product shelf life and performance.
• Reduces legal and compliance risk by aligning with harmonized European and international standards.
• Enhances market competitiveness with internationally recognized stability data and documentation.

Related Standards

When implementing stability evaluation for IVD reagents, the following standards are also relevant:

• ISO 18113-1:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
• EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
• CLSI EP25-ED2:2023 - Evaluation of Stability of In Vitro Diagnostic Reagents
• EN 13640 - Stability testing of in vitro diagnostic reagents
• Regulation (EU) 2017/746 - In vitro diagnostic medical devices (IVDR)

oSIST prEN ISO 23640:2026 provides a robust framework for verifying the stability of IVD reagents, ensuring compliance, product reliability, and patient safety in the fast-evolving field of in vitro diagnostics. For organizations developing, manufacturing, or using IVD reagents, adherence to this standard is crucial for quality assurance and regulatory acceptance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
In vitro diagnostične medicinske naprave - Vrednotenje stabilnosti in vitro
diagnostičnih reagentov (ISO/DIS 23640:2026)
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
(ISO/DIS 23640:2026)
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische
Untersuchungen (ISO/DIS 23640:2026)
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de
diagnostic in vitro (ISO/DIS 23640:2026)
Ta slovenski standard je istoveten z: prEN ISO 23640
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 23640
ISO/TC 212
In vitro diagnostic medical
Secretariat: ANSI
devices — Evaluation of stability of
Voting begins on:
in vitro diagnostic reagents
2026-05-06
Dispositifs médicaux de diagnostic in vitro — Évaluation de la
Voting terminates on:
stabilité des réactifs de diagnostic in vitro
2026-07-29
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 23640:2026(en)
DRAFT
ISO/DIS 23640:2026(en)
International
Standard
ISO/DIS 23640
ISO/TC 212
In vitro diagnostic medical
Secretariat: ANSI
devices — Evaluation of stability of
Voting begins on:
in vitro diagnostic reagents
Dispositifs médicaux de diagnostic in vitro — Évaluation de la
Voting terminates on:
stabilité des réactifs de diagnostic in vitro
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 23640:2026(en)
ii
ISO/DIS 23640:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 General principles .4
4.2 Protocol .5
4.3 Stability reports .6
5 Procedures . 6
5.1 General .6
5.1.1 Purpose .6
5.1.2 Examinations .6
5.1.3 Number of batches to be examined .7
5.2 Real time stability evaluation .7
5.2.1 Shelf life .7
5.2.2 Stability during transport .7
5.2.3 In-use stability .7
5.3 Accelerated stability evaluation .7
5.3.1 Procedure .7
5.3.2 Analysis of data .8
5.3.3 Evaluations and conclusions .8
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 9
Bibliography .12

iii
ISO/DIS 23640:2026(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212 Medical laboratories and in vitro diagnostic
systems.
This second edition cancels and replaces the first edition (ISO 23640:2011), which has been technically
revised.
The main changes are as follows:
— xxx xxxxxxx xxx xxxx
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DIS 23640:2026(en)
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 .
NOTE Regulatory approval requirements may vary, check with Regulatory Authorities in the target market.

v
DRAFT International Standard ISO/DIS 23640:2026(en)
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 documents are referred to in the text in such a way that some or all of their content constitutes
requirements 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.
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accelerated stability testing
a stability study designed to increase the rate of chemical or physical degradation of a product by using
exaggerated environmental conditions (eg, light, temperature, humidity);
Note 1 to entry: Results from such studies may be used to compare the influence of product design/packaging factors
or, in some cases, to estimate the expiry date when the product is handled under recommended storage conditions.
[SOURCE: CLSI EP25-ED2:2023]
ISO/DIS 23640:2026(en)
3.2
Arrhenius plot
a mathematical function that describes the approximate relationship between the rate constant of a chemical
reaction and the reaction temperature and energy of activation
[SOURCE: CLSI EP25-ED2:2023]
3.3
batch
lot
specified amount of material that is uniform in its properties and has been produced in one process or series
of processes
[SOURCE: ISO 18113-1:2022, 3.1.7, modified – Note 1 to entry has been deleted]
3.4
batch code
batch number
lot number
set of numbers and/or letters that specifically identifies a medical device or an IVD medical device and
permits its manufacturing, packaging, labelling and distribution history to be traced
[SOURCE: ISO 18113-1:2022, 3.1.8, modified – Note 1 to entry has been deleted]
3.5
calibration
operation that, under specified conditions, in a first step, establishes a relationship between the quantity
values with measurement, uncertainties provided by measurement standards, and corresponding
measurement indications with associated measurement uncertainties and, in a second step, uses this
information to establish a relationship for obtaining a measurement result from an indication
Note 1 to entry: Calibration permits either the assignment of values of the measurands to the measurement indications
provided by the measuring instrument, or the determination of a correction with respect to the values provided by
the measuring instrument.
Note 2 to entry: Calibration is sometimes confused with adjustment of a measuring system, often mistakenly called
self-calibration, or with calibration verification.
[SOURCE: ISO 18113-1:2022, 3.1.11]
3.6
calibrator
measurement standard used in the calibration (3.X) of an IVD instrument or system
[SOURCE: ISO 18113-1:2022, 3.1.13]
3.7
control material
substance, material, or article intended by its manufacturer to be used to verify the performance
characteristics of an IVD medical device (3.9)
[SOURCE: ISO 18113-1:2022, 3.1.15]
3.8
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
[SOURCE: ISO 18113-1:2022, 3.1.22, modified – Note 1 to entry has been deleted]

ISO/DIS 23640:2026(en)
3.9
IVD medical device
in vitro diagnostic medical device
medical device, whether 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
[SOURCE: ISO 18113-1:2022, 3.1.33, modified – Note 1 and Note 2 to entry has been deleted]
3.10
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
[SOURCE: ISO 18113-1:2022, 3.1.34]
3.11
real-time stability testing
exposing the product to the recommended normal storage and in-use conditions and assessing its robustness
and stability under those conditions.
[SOURCE: CLSI EP25-ED2:2023]
3.12
shelf life
period of time until the expiry date, during which an IVD reagent, in its original packaging, maintains its
stability under the storage conditions specified by the manufacturer
Note 1 to entry: Stability (3.13) and expiry date (3.8) are related concepts.
[SOURCE: ISO 18113-1:2022, 3.1.82]
3.13
stability
ability of an IVD medical device to maintain its performance characteristics within the limits specified by
the manufacturer
Note 1 to entry: Stability applies to:
— IVD reagents, calibrators, control materials, diluents, buffers and reagent kits, and specimen collection devices
that contain substances used to preserve samples or to initiate reactions for further processing of the sample in
the collection device , when stored, transported and used in the conditions specified by the manufacturer;
— reconstituted lyophilized materials, working solutions and materials removed from sealed containers (when
prepared, used and stored according to the manufacturer’s ins
...