prEN ISO 11140-3

SLOVENSKI STANDARD
01-september-2025
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Indikatorji
tipa 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare (ISO/DIS 11140-
3:2025)
Sterilization of health care products - Chemical indicators - Part 3: Type 2 indicators for
use in the Bowie and Dick-type steam penetration test (ISO/DIS 11140-3:2025)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3:
Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest
(ISO/DIS 11140-3:2025)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Indicateurs de Type
2 pour utilisation lors de l'essai de Bowie et Dick de pénétration de la vapeur (ISO/DIS
11140-3:2025)
Ta slovenski standard je istoveten z: prEN ISO 11140-3
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 11140-3
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Chemical indicators —
Voting begins on:
Part 3: 2025-07-29
Type 2 indicators for use in
Voting terminates on:
2025-10-21
the Bowie and Dick-type steam
penetration test
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 3: Indicateurs de Type 2 pour utilisation lors de l'essai de
Bowie et Dick de pénétration de la vapeur
ICS: 11.080.20
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.
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Reference number
ISO/DIS 11140-3:2025(en)
DRAFT
ISO/DIS 11140-3:2025(en)
International
Standard
ISO/DIS 11140-3
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Chemical indicators —
Voting begins on:
Part 3:
Type 2 indicators for use in
Voting terminates on:
the Bowie and Dick-type steam
penetration test
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 3: Indicateurs de Type 2 pour utilisation lors de l'essai de
Bowie et Dick de pénétration de la vapeur
ICS: 11.080.20
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 2025
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
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BE CONSIDERED IN THE LIGHT OF THEIR
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NATIONAL REGULATIONS.
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11140-3:2025(en)
ii
ISO/DIS 11140-3:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 3
5 Requirements . 3
6 Indicator format . 4
7 Performance requirements . . 4
8 Packaging and labelling . 5
Annex A (normative) Estimation of visual difference between colour of the substrate and of the
changed or unchanged indicator system by determination of relative reflectance density . 7
Annex B (normative) Determination of uniform colour change on exposure to saturated steam .11
Annex C (normative) Determination of non-uniform colour change on exposure to a reference
fault condition . .12
Annex D (normative) Reproducibility and determination of the reference fault condition in the
standard test pack . . 14
Annex E (normative) Determination of indicator colour change on exposure to dry heat .18
Annex F (normative) Determination of shelf life of indicators . 19
Annex G (normative) Determination of transfer of indicator to standard test pack on processing .20
Annex H (normative) Steam exposure apparatus and steam for test purposes .21
Annex I (normative) Standard test pack .24
Annex J (normative) Air injection system . .25
Annex K (informative) Relationship between chemical indicator components .27
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .28
Bibliography .31

iii
ISO/DIS 11140-3:2025(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).
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. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
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 198, Sterilization of health care products.
This third edition cancels and replaces the second edition (ISO 11140-3:2007), which has been technically
revised.
The main changes are as follows:
— change of title from class 2 indicator to type 2 indicator to align with ISO 11140-1;
— correct use of the terms indicator and indicator system to align with ISO 11140-1;
— updated normative references;
— inserted common Clause 4 for ISO/TC 198 documents, replacing Clause 8;
— aligned indicator labelling with ISO 11140-4;
— aligned Annex B with ISO 11140-4;
— modified Annex D to allow same methods of creating reference fault condition as ISO 11140-4;
— moved Annex F to Annex E;
— added Annex L, modified from ISO 11140-1.
A list of all parts in the ISO 11140 series can be found on the ISO website.
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 11140-3:2025(en)
Introduction
[1]
The Bowie and Dick test is a test for steam sterilizers for products to be sterilized that are within sterile
barrier systems or other porous loads. As such it is performed during the demonstration of conformance of
steam sterilizers to EN 285 and as a routine test in ISO 17665. The test method is described in EN 285.
A failure of the Bowie and Dick test is symptomatic of a number of potential problems with the sterilizer that
could compromise the uniform sterilization of a load to be processed. This failure is not conclusive proof
that the fault in the sterilizer is due to air retention, air leakage or non-condensable gases, and it can be
necessary to investigate other causes of failure.
The Bowie and Dick test was conceived as a test for successful steam penetration into a standardised test
[1]
load in high-vacuum porous-load sterilizers used in the sterilization of health care products. A successful
Bowie and Dick test indicates sufficient air removal to facilitate rapid and even penetration of steam into
the test load. A failure of the Bowie and Dick test is symptomatic of a number of potential problems with the
sterilizer that could compromise sterilization of the load. The presence of air within the load may be due to
an inefficient air removal stage, an air leak during the air removal stage, or non-condensable gases in the
steam supply, are circumstances that can lead to failure of the test. This failure is not conclusive proof that
the fault is due to air retention, air leakage or non- condensable gases, and it can be necessary to investigate
other causes of failure.
The result of the test can also be affected by other factors which inhibit steam penetration. The test does
not necessarily demonstrate either achievement of the required temperature or maintenance of that
temperature for the required time to achieve sterilization.
In this document, the Bowie and Dick test consists of two components:
a) a small, standardised test load;
b) a chemical indicator to detect the presence of steam.
[1]
The Bowie and Dick test as originally described utilized huckaback towels as the material for the test
load. The test as described in EN 285 uses cotton sheets for this
...