EN ISO 11140-3:2009

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 11140-3:2007
SIST EN ISO 11140-3:2007/AC:2008
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Sistemi
indikatorjev razreda 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare
(ISO 11140-3:2007)
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator
systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3:
Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest
(ISO 11140-3:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Systèmes
d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration
de la vapeur (ISO 11140-3:2007)
Ta slovenski standard je istoveten z: EN ISO 11140-3:2009
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.

EUROPEAN STANDARD
EN ISO 11140-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11140-3:2007
English Version
Sterilization of health care products - Chemical indicators - Part
3: Class 2 indicator systems for use in the Bowie and Dick-type
steam penetration test (ISO 11140-3:2007, including Cor
1:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 3: Systèmes d'indicateurs de Classe 2 pour Chemische Indikatoren - Teil 3: Indikatorsysteme der
utilisation lors de l'essai de Bowie et Dick de pénétration de Klasse 2 zur Verwendung im Bowie-Dick-
la vapeur (ISO 11140-3:2007, Cor 1:2007 inclus) Dampfdurchdringungstest (ISO 11140-3:2007,
einschließlich Cor 1:2007)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-3:2009: 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 93/42/EEC .4

Foreword
The text of ISO 11140-3:2007, including Cor 1:2007 has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 11140-3:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”
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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 11140-3:2007.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
The series EN ISO 11140 consists of the following parts under the general title Sterilization of health care
products - Chemical indicators:
 Part 1: General requirements
 Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
 Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam
penetration.
Attention is drawn to the fact that the series ISO 11140 additionally consists of Part 5: Class 2 indicators for
Bowie and Dick-type air removal tests. However, this Part of ISO 11140 will not be part of the series
EN ISO 11140 because CEN/TC 102 decided not to adopt ISO 11140-5 as a European Standard.
In addition, reference is made to EN 867-5 Non-biological systems for use in sterilizers - Part 5: Specification
for indicator systems and process challenge devices for use in performance testing for small sterilizers type B
and type S and to EN ISO 15882 Sterilization of health care products - Chemical indicators - Guidance for
selection, use and interpretation of results: Both standards are currently being revised under the Vienna
Agreement (ISO/TC 198 lead).
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11140-3:2007, including Cor 1:2007 has been approved by CEN as a EN ISO 11140-3:2009
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
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 the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA 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 – Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4.1 5, 8, 7, 13 The requirements of ISO
11140-1 apply
6 7.1
7 13 [except 13.3 a) and 13.6 q)] The relevant Essential
Requirement 13.3a) is
partly addressed.
The relevant Essential
Requirement 13.q) is not
addressed in this European
Standard
7.4 7.1
8.1 7.1
WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the
scope of the standard.
INTERNATIONAL ISO
STANDARD 11140-3
Second edition
2007-03-15
Sterilization of health care products —
Chemical indicators —
Part 3:
Class 2 indicator systems for use in the
Bowie and Dick-type steam penetration
test
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 3: Systèmes d'indicateurs de Classe 2 pour utilisation lors de
l'essai de Bowie et Dick de pénétration de la vapeur

Reference number
ISO 11140-3:2007(E)
©
ISO 2007
ISO 11140-3:2007(E)
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ISO 11140-3:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 2
5 Indicator system format . 2
6 Performance requirements . 2
7 Packaging and labelling. 3
8 Quality assurance. 4
Annex A (normative) Determination of strength after steam sterilization . 5
Annex B (normative) Estimation of visual difference between colour of the substrate and the
changed (or unchanged) indicator system by determination of relative reflectance density. 6
Annex C (normative) Determination of indicator colour change on exposure to dry saturated
steam. 10
Annex D (normative) Determination of indicator colour change on exposure to dry heat . 11
Annex E (normative) Accelerated ageing of test samples. 12
Annex F (normative) Determination of transfer of indicator to standard test pack on processing . 13
Annex G (normative) Determination of shelf life of the product . 14
Annex H (normative) Steam exposure apparatus. 15
Annex I (normative) Determination of sensitivity of the indicator to the presence of air . 17
Annex J (normative) Air injection system . 18
Annex K (normative) Standard test pack. 20
Bibliography . 21

ISO 11140-3:2007(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 standardizati
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