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)

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3: Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007, einschließlich Cor 1:2007)

Dieser Teil von ISO 11140 legt die Anforderungen an chemische Indikatoren fest, die beim Dampfdurchdringungsversuch
für Dampfsterilisatoren für verpacktes Sterilisiergut, z. B. Instrumente und poröse Materialien,
verwendet werden sollen. Der Indikator für diesen Zweck ist ein Indikator der Klasse 2, wie er in ISO 11140-1
beschrieben wird.
Diesem Teil von ISO 11140 entsprechende Indikatoren sind zur Verwendung in Kombination mit dem Norm-
Prüfpaket, wie es in EN 285 beschrieben ist, vorgesehen. Dieser Teil von ISO 11140 berücksichtigt nicht die
Leistungsfähigkeit des Norm-Prüfpakets, sondern legt die Leistungsfähigkeit der Indikatorsysteme fest.

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, Cor 1:2007 inclus)

L'ISO 11140-3:2007 spécifie les exigences relatives aux indicateurs chimiques destinés à être utilisés dans l'essai de pénétration de la vapeur pour les produits emballés, par exemple les instruments et les matériaux poreux. L'indicateur prévu dans ce but est un indicateur de Classe 2, tel que décrit dans l'ISO 11140-1.
Les indicateurs conformes à l'ISO 11140-3:2007 sont destinés à être utilisés en association avec l'emballage d'essai normalisé tel que décrit dans l'EN 285. L'ISO 11140-3:2007 ne prend pas en compte la performance de cet emballage, mais spécifie la performance des indicateurs.

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)

General Information

Status
Published
Publication Date
05-May-2009
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
06-May-2009
Completion Date
06-May-2009

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SLOVENSKI STANDARD
SIST EN ISO 11140-3:2009
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
SIST EN ISO 11140-3:2009 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11140-3:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 11140-3:2009
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 11140-3:2009
EN ISO 11140-3:2009 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ...........................................................................................4

---------------------- Page: 4 ----------------------
SIST EN ISO 11140-3:2009
EN ISO 11140-3:2009 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 11140-3:2009
EN ISO 11140-3:2009 (E)
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.
---------------------- Page: 6 ----------------------
SIST EN ISO 11140-3:2009
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
---------------------- Page: 7 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)
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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.
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Published in Switzerland
ii © ISO 2007 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11140-3:2009
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 2007 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 11140-3:2009
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 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 11140-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This second edition cancels and replaces the first edition (ISO 11140-3:2000) 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
---------------------- Page: 10 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(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 leak during this stage or non-condensable gases in the steam supply, is a circumstance

which can lead to failure of the test. The result of the test may 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.

A test pack for the Bowie and Dick test consists of two components:
a) a small standardized 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 purpose.

Because a range of different tests in different countries has historically been termed the Bowie and Dick test,

the term “Bowie and Dick-type test” is used in this part of ISO 11140.
© ISO 2007 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 11140-3:2009
---------------------- Page: 12 ----------------------
SIST EN ISO 11140-3:2009
INTERNATIONAL STANDARD ISO 11140-3:2007(E)
Sterilization of health care products — Chemical indicators —
Part 3:
Class 2 indicator systems for use in the Bowie and Dick-type
steam penetration test
1 Scope

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration

test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this

purpose is a Class 2 indicator as described in ISO 11140-1.

Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test

pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test

pack, but does specify the performance of the indicator systems.
2 Normative references

The following referenced documents are indispensable for the application 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.

ISO 5-1, Photography — Density measurements — Part 1: Terms, symbols and notations

ISO 5-3, Photography — Density measurements — Part 3: Spectral conditions

ISO 5-4:1995, Photography — Density measurements — Part 4: Geometric conditions for reflection density

ISO 187:1990, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for

monitoring the atmosphere and conditioning of samples

ISO 2248, Packaging — Complete, filled transport packages — Vertical impact test by dropping

ISO 5457, Technical product documentation — Sizes and layout of drawing sheets

ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method

ISO 11140-1:2005, Sterilization of health care products — Chemical indicators — Part 1: General

requirements
ISO/CIE 10526:1999, CIE standard illuminants for colorimetry
EN 285:2006, Sterilization — Steam sterilizers — Large sterilizers
© ISO 2007 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11140-1 apply.

4 General requirements
4.1 The requirements of ISO 11140-1 apply.

4.2 Test samples shall be conditioned in accordance with ISO 187 prior to testing for performance.

5 Indicator system format
The indicator system format shall meet the following requirements.

a) It shall consist of indicator reagent uniformly distributed on a substrate to cover not less than 30 % of the

surface area of the substrate. The distance between adjacent areas of indicator reagent shall not exceed

20 mm. The pattern of indicator reagent distribution should permit easy comparison of the colour change

at the margin with the colour change in the central region.

b) It shall have an air porosity not less than 1,7 µm/(Pa s) when tested in accordance with ISO 5636-3 at an

air pressure of 1,47 kPa.
c) It shall have sufficient strength to withstand steam sterilization.
Compliance shall be tested in accordance with Annex A.
d) It shall have a substrate of a colour that is uniform to visual observation.

e) It shall have a difference in reflectance density of not less than 0,3 between the substrate and either the

changed indicator or the unchanged indicator as specified by the manufacturer.
Compliance shall be tested in accordance with Annex B.

f) It shall permit writing in permanent ink to be made legibly on both processed and unprocessed materials.

Markings made before processing shall be legible after processing.
g) It shall be of size A4 in accordance with ISO 5457.
6 Performance requirements
6.1 The indicator shall meet the following requirements.

a) It shall show a uniform colour change complying with 5 e) after exposure to dry saturated steam at

+1,5 +1,5

134 ( ) °C for 3,5 min ± 5 s or after exposure to dry saturated steam at 121 ( ) °C for 15 min ± 5 s or

0 0
both.
Compliance shall be tested in accordance with Annex C.

b) When placed in the centre of a standard test pack, it shall show a non-uniform colour change when the

temperature at the centre of the standard test pack is 2 K lower than the temperature of the chamber

drain of the steam exposure apparatus (see Annex H).
Compliance shall be tested in accordance with Annex I.
2 © ISO 2007 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)

c) It shall show no discernible colour change after exposure to dry heat at (140 ± 2) °C for not less than

30 min.
Compliance shall be demonstrated in accordance with Annex D.

With some indicators a slight colour change can occur. This shall be acceptable if the change that occurs

is markedly different from that brought about by exposure to steam in accordance with 6.1 a) and within

the limits specified by the manufacturer.

d) It shall not visibly transfer indicator reagent to the material of the test load in intimate contact with the

indicator during processing.
Compliance shall be demonstrated in accordance with Annex F.

6.2 The indicator shall comply with the requirements of this part of ISO 11140 for the duration of the shelf

life specified by the manufacturer.

If any change in the indicator occurs during ageing, it shall be different to the change on exposure to dry

saturated steam [as described in 6.1 a)], and shall have either inactivated the indicator so that no further

change can take place or not affected the performance of the indicator with respect to the requirements of

6.1 a) and 6.1 b).

Compliance shall be tested in accordance with Annex G or by performance testing after accelerated ageing in

accordance with Annex E.
7 Packaging and labelling

7.1 Each substrate on which an indicator reagent has been deposited shall be marked with the operating

temperature(s) for which the product is designed to be used.

7.2 Each indicator shall be marked with a unique code from which the manufacturing history can be traced.

7.3 Each indicator shall be provided with space for the user to record essential cycle information under the

headings:
⎯ department;
⎯ machine No.;
⎯ cycle No.;
⎯ operator;
⎯ date;
⎯ result;
⎯ supervisor.

Adjacent to each heading there shall be a clear space not less than 5 mm × 20 mm for the user to enter the

required information at the time of use. See Figure 1.

7.4 The product shall be packed in such a way as to allow easy separation of individual units of product and

to protect the product from moisture, dust, sunlight and damage in normal transit, to the extent necessary to

ensure that the indicator retains its performance throughout the stated shelf life when stored in accordance

with the manufacturer's instructions.
The manufacturer shall retain documentary evidence demonstrating compliance.
© ISO 2007 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)

7.5 The outside of each carton shall be marked with the operating temperature at which the product is

suitable for use.

7.6 The information supplied by the manufacturer (see 5.7 and 5.8 of ISO 11140-1:2005) shall include

sufficient instruction on the use of the indicator to enable correct interpretation of the test results.

Department
Machine No.
Cycle No.
Operator
Date
Result
Supervisor
NOTE Other formats may be used.
Figure 1 — Example of a suitable format
8 Quality assurance

8.1 The quality system shall ensure that the performance requirements given in Clause 6 are maintained.

8.2 Suitable records shall be maintained to ensure that, in the event of a defect arising, faulty batches can

be recalled from use.

8.3 The manufacturing and distribution records shall be retained for a period of five years or twice the

declared shelf life of the product, whichever is less. An example of the requirements for maintaining records is

[4]
given in ISO 9001 .
4 © ISO 2007 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)
Annex A
(normative)
Determination of strength after steam sterilization
A.1 Apparatus
A.1.1 Steam exposure apparatus, as specified in Annex H.
A.1.2 Standard test pack, as specified in Annex K.
A.1.3 Steam supply, as specified in EN 285.
A.2 Procedure

A.2.1 Expose the indicator, within a standard test pack, to three successive steam exposures at the stated

operating temperature of the indicator system.

A.2.2 Remove the standard test pack from the exposure apparatus and perform a drop test in accordance

with ISO 2248 from a height of 1 m on to a firm horizontal surface.
NOTE Concrete or terrazzo surfaces are suitable.

A.2.3 Remove the indicator from the standard test pack and visually examine for damage.

A.2.4 Repeat this test for each of three separate production batches of the indicator system.

© ISO 2007 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)
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
B.1 Principle

The relative reflectance density, D , as defined in ISO 5-1, of the changed or unchanged indicator and the

substrate are determined in accordance with the methods given below, which are based on ISO 5-3 and

ISO 5-4, to which reference shall also be made.
D = − log R
Rf 10 f
R = Φ /Φ
f c ce
where
Φ is the reflected flux from the indicator;
Φ is the reflected flux from the substrate.

To completely define a type of density, spectrally, it is necessary to specify the light source, optics and

spectral response of the measuring system.
B.2 Apparatus
B.2.1 Steam exposure apparatus, as specified in Annex H.
B.2.2 Photoelectric reflectance photometer, as specified in B.3.2.
B.3 Measurement
B.3.1 Illumination

The relative spectral power distribution of the incident flux shall conform to CIE standard illuminant D , in

accordance with ISO/CIE 10526:1999.
NOTE This is regarded as equivalent to “Daylight - cloudy northern sky.”
B.3.2 Measuring instrument
B.3.2.1 General

The measuring instrument shall be a photoelectric instrument giving within 0,3 % an indicated reading

proportional to the intensity of light reflected from the surface under test.
6 © ISO 2007 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 11140-3:2009
ISO 11140-3:2007(E)
B.3.2.2 Optical geometry

The measuring instrument shall have optical geometry conforming to the requirements of ISO 5-4. This

includes illumination of the specimen at angles between 40° and 50°, viewed along the normal (0°) with an

angle of acceptance (observer angle) of 10°.

The dimensions of the instrument's measurement aperture shall permit the measurement aperture to be

entirely filled with substrate or indicator.

To minimize measurement errors, the optical system should be equipped with a polarizing filter if the surface

to be measured is highly reflecting, e.g. a plastic-coated surface.
B.3.2.3 Spectral response
For the
...

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