EN ISO 11140-4:2007

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).
An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.
This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 4: Indikatoren der Klasse 2, die alternativ zum Bowie-Dick-Test für den Nachweis der Dampfdurchdringung verwendet werden (ISO 11140-4:2007)

Dieser Teil von ISO 11140 legt die Leistungsanforderungen für einen Indikator der Klasse 2 fest, der alternativ zum Bowie Dick Test in Dampfsterilisatoren für verpackte Güter (Instrumente usw. und poröse Ladungen) zu verwenden ist.
ANMERKUNG   Der Bowie Dick Test wird zur Routineprüfung von Dampfsterilisatoren und zur Validierung von Sterilisationsverfahren mit Dampf verwendet.
Ein Indikator, der diesem Teil von ISO 11140 entspricht, enthält ein festgelegtes Material, welches als Prüfladung verwendet wird. Diese Prüfladung kann zum einmaligen oder mehrmaligen Gebrauch vorgesehen sein. Dieser Teil von ISO 11140 legt keine Anforderungen an die Prüfladung fest, sondern enthält Festlegungen zur Leistungsfähigkeit des Indikators in Verbindung mit der Prüfladung, mit der er zu verwenden ist. Der in diesem Teil von ISO 11140 festgelegte Indikator dient dem Nachweis unzureichender Dampfdurchdringung, zeigt jedoch nicht unbedingt deren Ursache an.
Dieser Teil von ISO 11140 enthält keine Prüfverfahren, um die Eignung dieser Indikatorsysteme für den Gebrauch in Sterilisatoren festzulegen, in denen die Luftentfernungsstufe keine Evakuierung unter den Atmosphären¬druck einschließt.

Stérilisation des produits de santé - Indicateurs chimiques - Partie 4: Indicateurs de Classe 2 comme alternative à l'essai de Bowie et Dick pour la détection de la pénétration de la vapeur (ISO 11140-4:2007)

L'ISO 11140-4:2007 spécifie les performances des indicateurs de Classe 2, destinés à être utilisés pour les stérilisateurs à la vapeur, comme alternative à l'essai de Bowie et Dick pour les produits de santé emballés (par exemple les instruments et les charges poreuses).
Un indicateur conforme à l'ISO 11140-4:2007 incorpore un matériau spécifié utilisé comme charge d'essai. Cette charge d'essai peut être ou non réutilisable. L'ISO 11140-4:2007 ne spécifie aucune exigence relative à la charge d'essai; en revanche, elle spécifie les performances de l'indicateur utilisé conjointement avec la charge d'essai pour laquelle il est conçu. Les indicateurs spécifiés dans l'ISO 11140-4:2007 sont conçus pour identifier les cas d'admission inefficace de la vapeur mais n'en indiquent pas nécessairement la cause.
L'ISO 11140-4:2007 ne décrit aucune méthode d'essai permettant d'établir dans quelle mesure ces indicateurs sont adaptés aux stérilisateurs dans lesquels l'extraction de l'air n'inclut pas de phase d'extraction à des pressions inférieures à la pression atmosphérique

Sterilizacija izdelkov za zdravstveno nego – Kemijski indikatorji – 4. del: Indikatorji razreda 2, ki se uporabljajo namesto Bowie-Dickovega preskusa za ugotavljanje prodiranja pare (ISO 11140-4:2007)

General Information

• Status: Published
• Publication Date: 14-Mar-2007
• Withdrawal Date: 29-Sep-2007
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 7 - Biological and chemical indicators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Mar-2007
• Completion Date: 15-Mar-2007
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11140-4:2007 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)

Relations

• Replaces: EN 867-4:2000 - Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2007
1DGRPHãþD
SIST EN 867-4:2001
Sterilizacija izdelkov za zdravstveno nego – Kemijski indikatorji – 4. del: Indikatorji
razreda 2, ki se uporabljajo namesto Bowie-Dickovega preskusa za ugotavljanje
prodiranja pare (ISO 11140-4:2007)
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as
an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO
11140-4:2007)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 4:
Indikatoren der Klasse 2, die alternativ zum Bowie-Dick-Test für den Nachweis der
Dampfdurchdringung verwendet werden (ISO 11140-4:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 4: Indicateurs de
classe 2 comme alternative a l'essai de Bowie et Dick pour la détection de la pénétration
de la vapeur (ISO 11140-4:2007)
Ta slovenski standard je istoveten z: EN ISO 11140-4:2007
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 11140-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2007
ICS 11.080.01 Supersedes EN 867-4:2000
English Version
Sterilization of health care products - Chemical indicators - Part
4: Class 2 indicators as an alternative to the Bowie and Dick-
type test for detection of steam penetration (ISO 11140-4:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 4: Indicateurs de Classe 2 comme alternative à Chemische Indikatoren - Teil 4: Indikatoren der Klasse 2,
l'essai de Bowie et Dick pour la détection de la pénétration die alternativ zum Bowie-Dick-Test für den Nachweis der
de la vapeur (ISO 11140-4:2007) Dampfdurchdringung verwendet werden (ISO 11140-
4:2007)
This European Standard was approved by CEN on 14 March 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-4:2007: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11140-4:2007) has been prepared by Technical Committee ISO/TC
198 "Sterilization of health care products" in collaboration with 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 September 2007, and conflicting
national standards shall be withdrawn at the latest by September 2007.

This document supersedes EN 867-4:2000.

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(s).
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 United
Kingdom.
Endorsement notice
The text of ISO 11140-4:2007 has been approved by CEN as EN ISO 11140-4:2007 without
any modifications.
INTERNATIONAL ISO
STANDARD 11140-4
Second edition
2007-03-15
Sterilization of health care products —
Chemical indicators —
Part 4:
Class 2 indicators as an alternative to the
Bowie and Dick-type test for detection of
steam penetration
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 4: Indicateurs de Classe 2 comme alternative à l'essai de Bowie
et Dick pour la détection de la pénétration de la vapeur

Reference number
ISO 11140-4:2007(E)
©
ISO 2007
ISO 11140-4:2007(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2007
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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved

ISO 11140-4:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 3
5 Indicator system format . 4
6 Performance requirements . 4
7 Packaging and labelling. 6
8 Quality assurance. 7
Annex A (normative) Determination of indicator strength during and after steam sterilization . 8
Annex B (normative) Standard test cycles. 10
Annex C (normative) Estimation of visual difference between colour of the substrate and of the
changed or unchanged indicator system by determination of relative reflectance density . 15
Annex D (normative) Determination of uniform colour change on exposure to saturated steam . 19
Annex E (normative) Determination of equivalence of the alternative indicator to the Bowie and
Dick test . 20
Annex F (normative) Determination of reproducibility of fail conditions created in a standard test
pack by air injection, air leak and retained air systems . 22
Annex G (normative) Determination of indicator colour change on exposure to dry heat . 26
Annex H (normative) Determination of shelf life of product. 27
Annex I (normative) Accelerated ageing of test samples . 28
Annex J (normative) Steam exposure apparatus and steam for test purposes. 29
Annex K (normative) Standard test pack. 32
Annex L (normative) Air injection system . 33
Bibliography . 35

ISO 11140-4:2007(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 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 11140-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11140-4:2001) which has been technically
revised.
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
⎯ Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
iv © ISO 2007 – All rights reserved

ISO 11140-4:2007(E)
Introduction
The Bowie and Dick test is a performance test for steam sterilizers for wrapped goods and porous loads. As
such it is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine
test of performance in ISO 17665-1. 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 air removal from high-vacuum porous-load
[1]
sterilizers used in the sterilization of health care products . A successful Bowie and Dick test indicates rapid
and even penetration of steam into the test pack. The presence of air within the pack, due to an inefficient air
removal stage, an air
...