SIST EN ISO 11140-1:2009
(Main)Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2005)
1.1 Dieser Teil von ISO 11140 legt allgemeine Anforderungen und Prüfverfahren für Indikatoren fest, die
deren Exposition gegenüber Sterilisationsverfahren durch physikalische und/oder chemische Veränderungen
von Substanzen sichtbar machen und die dazu verwendet werden, um die Erreichung einer oder mehrerer
Variablen zu überwachen, die für ein Sterilisationsverfahren erforderlich sind. Sie sind in ihrer Wirkung vom
Vorhandensein oder der Abwesenheit eines lebenden Organismus unabhängig.
ANMERKUNG Als biologische Prüfsysteme werden diejenigen Prüfungen angesehen, die für ihre Auswertung vom
Nachweis der Lebensfähigkeit eines Organismus abhängig sind. Prüfsysteme dieser Art werden in der Normenreihe
ISO 11138 für biologische Indikatoren (BI) behandelt.
1.2 Die Anforderungen und Prüfverfahren dieses Teils von ISO 11140 gelten für alle Indikatoren, die in
nachfolgenden Teilen von ISO 11140 festgelegt werden, außer wenn die Anforderung in einem nachfolgenden
Teil abgeändert oder hinzugefügt wird; in diesem Fall gilt die Anforderung dieses besonderen Teils.
Die einschlägigen Prüfgeräte werden in ISO 18472 beschrieben.
ANMERKUNG Zusätzliche Anforderungen für spezifische Prüfindikatoren (Indikatoren der Klasse 2) sind in ISO 11140-3,
ISO 11140-4 und ISO 11140-5 angegeben.
Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (ISO 11140-1:2005)
L'ISO 11140-1:2005 spécifie les exigences générales et les modes opératoires d'essai relatifs aux indicateurs exposés à des procédés de stérilisation par modification des substances de nature physique et/ou chimique, qui sont utilisés pour contrôler l'acquisition d'un ou plusieurs paramètre(s) requis pour un procédé de stérilisation. Ils ne dépendent pas de leur action en présence ou en l'absence d'un organisme vivant.
Les exigences et les méthodes d'essai de la présente partie de l'ISO 11140 s'appliquent à tous les indicateurs spécifiés dans les parties suivantes de l'ISO 11140, sauf en cas de modification de l'exigence ou ajout de celle-ci dans une partie suivante, auquel cas l'exigence de cette partie spécifique s'appliquera.
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11140-1:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11140-1:2005
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne
zahteve (ISO 11140-1:2005)
Sterilization of health care products - Chemical indicators - Part 1: General requirements
(ISO 11140-1:2005)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11140-1:2005)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences
générales (ISO 11140-1:2005)
Ta slovenski standard je istoveten z: EN ISO 11140-1:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11140-1:2009
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SIST EN ISO 11140-1:2009
EUROPEAN STANDARD
EN ISO 11140-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11140-1:2005
English Version
Sterilization of health care products - Chemical indicators - Part
1: General requirements (ISO 11140-1:2005)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences générales (ISO 11140-1:2005) Chemische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11140-1:2005)
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 11140-1:2009: E
worldwide for CEN national Members.
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SIST EN ISO 11140-1:2009
EN ISO 11140-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 11140-1:2009
EN ISO 11140-1:2009 (E)
Foreword
The text of ISO 11140-1:2005 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
11140-1:2009 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 11140-1:2005.
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.
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 11140-1:2005 has been approved by CEN as a EN ISO 11140-1:2009 without any
modification.
3
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SIST EN ISO 11140-1:2009
EN ISO 11140-1:2009 (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
4.2 to 4.7 8, 7
5.5 5
5.8 13 [except 13.3 a) and 13.6 q)] The relevant Essential
Requirement 13.3 a) is
partly addressed.
The relevant Essential
Requirement 13.6 q) is not
addressed in this European
Standard
6.1 10.1
8 10.1
WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the
scope of the standard.
4
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SIST EN ISO 11140-1:2009
INTERNATIONAL ISO
STANDARD 11140-1
Second edition
2005-07-15
Sterilization of health care products —
Chemical indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 1: Exigences générales
Reference number
ISO 11140-1:2005(E)
©
ISO 2005
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(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,
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Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Classification. 3
5 General requirements. 4
6 Performance requirements . 6
7 Test methods. 7
8 Additional requirements for process (Class 1) indicators . 10
9 Additional requirements for single variable (Class 3) indicators . 13
10 Additional requirements for multi-variable (Class 4) indicators. 13
11 Additional requirements for steam integrating (Class 5) indicators . 14
12 Additional requirements for dry heat integrating (Class 5) indicators . 14
13 Additional requirements for ethylene oxide integrating (Class 5) indicators . 15
14 Additional requirements for emulating (Class 6) indicators . 16
Annex A (informative) Method for demonstrating shelf life of the product . 17
Annex B (informative) Examples of testing indicators. 18
Annex C (informative) Rationale for the requirements for integrating indicators and the link to the
requirements for biological indicators (BIs) specified in ISO 11138 and microbial
inactivation . 19
Annex D (informative) Rationale for the liquid-phase test method for steam-formaldehyde
indicators. 25
Annex E (informative) Relationship of indicator components. 26
Bibliography . 27
© ISO 2005 – All rights reserved iii
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(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 11140-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11140-1:1995 and
ISO 11140-1:1995/Amd.1:1998), 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 2: Test equipment and methods
Part 3: Class 2 indicators for steam penetration test sheets
Part 4: Class 2 indicators for steam penetration test packs
Part 5: Class 2 indicators for air removal test sheets and packs
NOTE ISO 11140-2 is to be replaced by ISO 18472, Sterilization of health care products — Biological and chemical
indicators — Test equipment.
iv © ISO 2005 – All rights reserved
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
Introduction
This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators
intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation,
steam-formaldehyde or vaporized hydrogen peroxide.
Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of
moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general
requirements will apply.
The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of
ISO 11140.
Standards for sterilizers and for the validation and process control of sterilization, describe performance tests
for sterilizers and methods of validation and routine control, respectively.
This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general
requirements for chemical indicators. Subsequent parts of this International Standard specify the particular
requirements for chemical indicators for particular applications and for defined tests of particular sterilization
processes used in health care, including industry. The use of the indicators specified in this part of ISO 11140
are described in ISO 15882, EN 285, ISO 11135 and ISO 17665.
Resistometers (see ISO 18472) are used to characterize the performance of the chemical indicators described
in this part of ISO 11140. Resistometers allow for precise variation of the specific test conditions and cycle
sequences in order to produce controlled physical studies. Resistometers differ from conventional sterilizers;
therefore, if conventional sterilizers are used to attempt to duplicate resistometer conditions, erroneous and/or
misleading results may occur.
© ISO 2005 – All rights reserved v
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SIST EN ISO 11140-1:2009
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SIST EN ISO 11140-1:2009
INTERNATIONAL STANDARD ISO 11140-1:2005(E)
Sterilization of health care products — Chemical indicators —
Part 1:
General requirements
WARNING — The use of this part of ISO 11140 may involve hazardous materials, operations and
equipment. This part of ISO 11140 does not purport to address to all the safety problems associated
with its use. It is the responsibility of the user of this part of ISO 11140 to establish appropriate safety
and health practise and determine the applicability of regulatory limitations prior to use.
1 Scope
1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show
exposure to sterilization processes by means of physical and/or chemical change of substances, and which
are used to monitor the attainment of one or more of the variables required for a sterilization process. They
are not dependent for their action on the presence or absence of a living organism.
NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the
demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for
biological indicators (BIs).
1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in
subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which
case the requirement of that particular part will apply.
Relevant test equipment is described in ISO 18472.
NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4
and ISO 11140-5.
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 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 11138 (all parts), Sterilization of health care products — Biological indicator systems
ISO 11607, Packaging for terminally sterilized medical devices
1)
ISO 18472 , Sterilization of health care products — Biological and chemical indicators — Test equipment
1) To be published.
© ISO 2005 – All rights reserved 1
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
bleed
lateral migration of the indicator agent beyond the margins within which the indicator agent was applied
3.2
critical variable
parameters identified as being essential to the sterilization process (and requiring monitoring)
3.3
endpoint
point of the observed change as defined by the manufacturer occurring after the indicator has been exposed
to specified stated values
3.4
graduated response
progressive observable change occurring on exposure to one or more process variables allowing assessment
of the level achieved
3.5
indicator
combination of the indicator agent and its substrate in the final form in which it is intended to be used (see
Annex E)
NOTE An indicator system in combination with a specific test load is also termed an indicator.
3.6
indicator agent/indicator reagent
active substance(s) or combination of substances (see Annex E)
3.7
indicator system
combination of the indicator agent and its substrate subsequently intended to be used in combination with a
specific test load
3.8
off-set
transfer of indicator agent to a material in intimate contact with the surface of the indicator
3.9
parameter
specified value for a process variable
3.10
penetration
migration of the indicator agent through the substrate to the surface opposite the one to which the indicator
agent was applied
3.11
saturated steam
water vapour in a state of equilibrium between condensation and evaporation
2 © ISO 2005 – All rights reserved
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
3.12
stated value
SV
value or values of a critical variable at which the indicator is designed to reach its endpoint as defined by the
manufacturer
3.13
substrate
carrier or support material onto which the indicator is applied (see Annex E)
3.14
variable
condition within a sterilization process, changes that alter microbicidal effectiveness
3.15
visible change
change defined by the manufacturer, which can be seen in the indicator after exposure to one or more critical
variables of the process
NOTE Visible change is used to describe the response of Class 1 process indicators.
4 Classification
4.1 General
In subsequent parts of ISO 11140, indicators are classified by their intended use. The chemical indicators
described in this part of ISO 11140 are classified into six groups. The chemical indicators within each of these
classifications are further subdivided by the sterilization process for which they are designed to be used. The
classification structure used is solely to denote the characteristics and intended use of each type of indicator
when used as defined by the manufacturer. This classification has no hierarchical significance.
4.2 Class 1: process indicators
Process indicators are intended for use with individual units (e.g. packs, containers) to indicate that the unit
has been directly exposed to the sterilization process and to distinguish between processed and unprocessed
units. They shall be designed to react to one or more of the critical process variables (see Tables 1 to 6).
4.3 Class 2: indicators for use in specific tests
Class 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization
standards.
NOTE The requirements for specific test indicators (Class 2 indicators) are provided in other parts of ISO 11140.
4.4 Class 3: single variable indicators
A single variable indicator shall be designed to react to one of the critical variables (see 5.2) and is intended to
indicate exposure to a sterilization process at a stated value (SV) of the chosen variable (see 5.7 and 5.8).
4.5 Class 4: multi-variable indicators
A multi-variable indicator shall be designed to react to two or more of the critical variables (see 5.2) and is
intended to indicate exposure to a sterilization cycle at SVs of the chosen variables (see 5.7 and 5.8).
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
4.6 Class 5: integrating indicators
Integrating indicators shall be designed to react to all critical variables. The SVs are generated to be
equivalent to, or exceed the performance requirements given in the ISO 11138 series for BIs (see Clauses 11,
12 and 13).
4.7 Class 6: emulating indicators
Emulating indicators are cycle verification indicators which shall be designed to react to all critical variables for
specified sterilization cycles. The SVs are generated from the critical variables of the specified sterilization
process.
5 General requirements
5.1 The requirements given in this clause shall apply to all indicators unless specifically excluded or
amended in a subsequent clause or part of ISO 11140.
5.2 For the different sterilization processes, the following variables are defined as being critical:
• STEAM Time, temperature and water (as delivered by saturated steam)
• DRY HEAT Time and temperature
• ETHYLENE OXIDE Time, temperature, relative humidity and ethylene oxide (EO)
concentration
• IRRADIATION Total absorbed dose
• STEAM-FORMALDEHYDE Time, temperature, water (as delivered by saturated steam) and
formaldehyde concentration
• VAPOURIZED Time, temperature, hydrogen peroxide concentration, and, if applicable,
HYDROGEN PEROXIDE plasma
5.3 The manufacturer shall establish, document and maintain a formal quality system to cover all
operations required by this part of ISO 11140.
NOTE ISO 9001 and ISO 13485 describe requirements for quality systems for design, manufacture and testing.
5.4 Each indicator shall be clearly marked with the type of process for which it is intended to be used
(see 5.6 and 5.7), with the the class of indicator (see Clause 4), and for Class 3, 4, 5 and 6 indicators, with the
the SVs.
Where the size or format of the indicator does not permit this information to be stated in a font of 6 characters
per centimetre or larger, the information shall be provided on the label and/or instructions for use.
5.5 The indicator shall comply with the requirements of this part of ISO 11140 for the duration of the shelf
life as specified by the manufacturer (see Annex A).
4 © ISO 2005 – All rights reserved
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
5.6 Abbreviated descriptions of the process shall be in accordance with the following symbols:
STEAM
all steam sterilization processes
DRY
all dry heat sterilization processes
EO
all ethylene oxide sterilization processes
IRRAD
all ionizing radiation sterilization processes
FORM
all steam/formaldehyde sterilization processes
VH2O2
all vaporized hydrogen peroxide sterilization processes
These descriptions are symbols and should not be translated.
5.7 If the indicator is designed for use in specific sterilization cycles, this information shall be stated or
coded on the indicator, e.g.
STEAM
121 °C 15 min
(See 3.12 and 5.6.)
5.8 Each package of indicators or the technical information leaflet supplied with the package shall provide
the following information:
a) the change that is intended to occur; and for colour change indicators where the colour change cannot be
adequately described, samples of the expected colour range for both changed and unchanged indicators;
b) the critical variable(s) to which the indicator will respond, and where applicable, their SVs;
c) the class (see Clause 4), process (see 5.6) and intended use (see 5.7) for which the indicator is
designed;
d) the storage conditions, before and after use;
e) the expiry date, or the manufacturing date plus shelf life, under the specified storage conditions,
expressed in accordance with ISO 8601 (e.g. YYYY-MM);
f) a unique code (e.g. lot number) to provide traceability;
© ISO 2005 – All rights reserved 5
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SIST EN ISO 11140-1:2009
ISO 11140-1:2005(E)
g) instructions for use essential to ensure proper functioning of the indicator;
h) any interfering substances that are likely to be encountered, or conditions that are likely to occur, during
the intended use of the indicator and which are known to affect adversely the performance of the
indicator;
i) any safety precautions required during and/or after use;
j) the manufacturer's or supplier's name and address;
k) the nature of any change that can occur when completely/incompletely changed indicators are stored
according to the manufacturer’s instructions.
NOTE National or regional regulations could contain additional or different requirements.
5.9 The manufacturer shall retain documentary evidence that the indicator, when used as intended by the
manufacturer, does not release any substance known to be toxic in sufficient quantities to cause either a
health hazard, or a hazard to the intended properties of the product being sterilized before, during or after the
sterilization process for which it is designated.
6 Performance requirements
6.1 General
6.1.1 The condition of the indicator after exposure to a sterilization process, during which all the variables
met or exceeded the specified level to produce a visible change, graduated response or endpoint, shall
remain unchanged for a period of not less than six months from the date of use, when stored under the
conditions specified by the indicator manufacturer.
6.1.2 Incompletely changed indicators can deteriorate on storage, either returning to the unchanged
condition or slowly completing the change reaction. If such deterioration can occur, this information should be
stated in the technical information supplied by the manufacturer [see 5.8 k)].
6.2 Class 1 Indicators
6.2.1 The visible change that occurs after exposure of the indicator shall be clearly observable and shall be
either from light to dark, dark to light, or shall be from one colour to a distinctly different colour (see Clause 8).
6.2.2 When printed on to single-use packaging material complying with ISO 11607, the indicator agent shall
not bleed or offset to such an extent that it compromises the utility of the indicator or presents a hazard for the
use of the packaging material. Penetration shall not occur before, during or after the sterilization process for
which it is designed, when tested according to the method given in 7.2 (see also 5.9).
6.3 Class 2 indicators
Specific requirements for Class 2 indicators are given in Parts 3, 4 and 5 of ISO 11140.
6.4 Classes 3, 4, 5 and 6 indicators
6.4.1 The endpoint which occurs after exposure of the indicator to the SVs of critical va
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2005)Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2005)Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (ISO 11140-1:2005)Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:prEN ISO 11140-1kSIST prEN ISO 11140-1:2009en01-marec-2009kSIST prEN ISO 11140-1:2009SLOVENSKI
STANDARD
kSIST prEN ISO 11140-1:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 11140-1December 2008ICS 11.080.01Will supersede EN ISO 11140-1:2005
English VersionSterilization of health care products - Chemical indicators - Part1: General requirements (ISO 11140-1:2005)Stérilisation des produits de santé - Indicateurs chimiques -Partie 1: Exigences générales (ISO 11140-1:2005)Sterilisation von Produkten für die Gesundheitsfürsorge -Chemische Indikatoren - Teil 1: Allgemeine Anforderungen(ISO 11140-1:2005)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 102.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11140-1:2008: EkSIST prEN ISO 11140-1:2009
prEN ISO 11140-1:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 11140-1:2009
prEN ISO 11140-1:2008 (E) 3 Foreword The text of ISO 11140-1:2005 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 prEN ISO 11140-1:2008 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11140-1:2005. 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. Endorsement notice The text of ISO 11140-1:2005 has been approved by CEN as a prEN ISO 11140-1:2008 without any modification. kSIST prEN ISO 11140-1:2009
prEN ISO 11140-1:2008 (E) 4 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 WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard.
Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4.2 to 4.7 8, 7
5.5 5
5.8 13 [except 13.3 a) and 13.6 q)] The relevant Essential Requirement 13.3 a) is partly addressed. The relevant Essential Requirement 13.6 q) is not addressed in this European Standard 6.1 10.1
8 10.1
kSIST prEN ISO 11140-1:2009
Reference numberISO 11140-1:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO11140-1Second edition2005-07-15Sterilization of health care products — Chemical indicators — Part 1: General requirements Stérilisation des produits de santé — Indicateurs chimiques — Partie 1: Exigences générales
kSIST prEN ISO 11140-1:2009
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kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) © ISO 2005 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Classification.3 5 General requirements.4 6 Performance requirements.6 7 Test methods.7 8 Additional requirements for process (Class 1) indicators.10 9 Additional requirements for single variable (Class 3) indicators.13 10 Additional requirements for multi-variable (Class 4) indicators.13 11 Additional requirements for steam integrating (Class 5) indicators.14 12 Additional requirements for dry heat integrating (Class 5) indicators.14 13 Additional requirements for ethylene oxide integrating (Class 5) indicators.15 14 Additional requirements for emulating (Class 6) indicators.16 Annex A (informative)
Method for demonstrating shelf life of the product.17 Annex B (informative)
Examples of testing indicators.18 Annex C (informative)
Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in ISO 11138 and microbial inactivation.19 Annex D (informative)
Rationale for the liquid-phase test method for steam-formaldehyde indicators.25 Annex E (informative)
Relationship of indicator components.26 Bibliography.27
kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) iv © ISO 2005 – All rights reserved 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 11140-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-1:1995 and ISO 11140-1:1995/Amd.1:1998), 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 2: Test equipment and methods Part 3: Class 2 indicators for steam penetration test sheets Part 4: Class 2 indicators for steam penetration test packs Part 5: Class 2 indicators for air removal test sheets and packs NOTE ISO 11140-2 is to be replaced by ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment. kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) © ISO 2005 – All rights reserved vIntroduction This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation, steam-formaldehyde or vaporized hydrogen peroxide. Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general requirements will apply. The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of ISO 11140. Standards for sterilizers and for the validation and process control of sterilization, describe performance tests for sterilizers and methods of validation and routine control, respectively. This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general requirements for chemical indicators. Subsequent parts of this International Standard specify the particular requirements for chemical indicators for particular applications and for defined tests of particular sterilization processes used in health care, including industry. The use of the indicators specified in this part of ISO 11140 are described in ISO 15882, EN 285, ISO 11135 and ISO 17665. Resistometers (see ISO 18472) are used to characterize the performance of the chemical indicators described in this part of ISO 11140. Resistometers allow for precise variation of the specific test conditions and cycle sequences in order to produce controlled physical studies. Resistometers differ from conventional sterilizers; therefore, if conventional sterilizers are used to attempt to duplicate resistometer conditions, erroneous and/or misleading results may occur.
kSIST prEN ISO 11140-1:2009
kSIST prEN ISO 11140-1:2009
INTERNATIONAL STANDARD ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 1Sterilization of health care products — Chemical indicators — Part 1: General requirements WARNING — The use of this part of ISO 11140 may involve hazardous materials, operations and equipment. This part of ISO 11140 does not purport to address to all the safety problems associated with its use. It is the responsibility of the user of this part of ISO 11140 to establish appropriate safety and health practise and determine the applicability of regulatory limitations prior to use. 1 Scope 1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs). 1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant test equipment is described in ISO 18472. NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5. 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 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ISO 11138 (all parts), Sterilization of health care products — Biological indicator systems ISO 11607, Packaging for terminally sterilized medical devices ISO 184721), Sterilization of health care products — Biological and chemical indicators — Test equipment
1) To be published. kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) 2 © ISO 2005 – All rights reserved 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 bleed lateral migration of the indicator agent beyond the margins within which the indicator agent was applied 3.2 critical variable parameters identified as being essential to the sterilization process (and requiring monitoring) 3.3 endpoint point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values 3.4 graduated response progressive observable change occurring on exposure to one or more process variables allowing assessment of the level achieved 3.5 indicator combination of the indicator agent and its substrate in the final form in which it is intended to be used (see Annex E) NOTE An indicator system in combination with a specific test load is also termed an indicator. 3.6 indicator agent/indicator reagent active substance(s) or combination of substances (see Annex E) 3.7 indicator system combination of the indicator agent and its substrate subsequently intended to be used in combination with a specific test load 3.8 off-set transfer of indicator agent to a material in intimate contact with the surface of the indicator 3.9 parameter specified value for a process variable 3.10 penetration migration of the indicator agent through the substrate to the surface opposite the one to which the indicator agent was applied 3.11 saturated steam water vapour in a state of equilibrium between condensation and evaporation kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 33.12 stated value SV value or values of a critical variable at which the indicator is designed to reach its endpoint as defined by the manufacturer 3.13 substrate carrier or support material onto which the indicator is applied (see Annex E) 3.14 variable condition within a sterilization process, changes that alter microbicidal effectiveness 3.15 visible change change defined by the manufacturer, which can be seen in the indicator after exposure to one or more critical variables of the process NOTE Visible change is used to describe the response of Class 1 process indicators. 4 Classification 4.1 General In subsequent parts of ISO 11140, indicators are classified by their intended use. The chemical indicators described in this part of ISO 11140 are classified into six groups. The chemical indicators within each of these classifications are further subdivided by the sterilization process for which they are designed to be used. The classification structure used is solely to denote the characteristics and intended use of each type of indicator when used as defined by the manufacturer. This classification has no hierarchical significance. 4.2 Class 1: process indicators Process indicators are intended for use with individual units (e.g. packs, containers) to indicate that the unit has been directly exposed to the sterilization process and to distinguish between processed and unprocessed units. They shall be designed to react to one or more of the critical process variables (see Tables 1 to 6). 4.3 Class 2: indicators for use in specific tests Class 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization standards. NOTE
The requirements for specific test indicators (Class 2 indicators) are provided in other parts of ISO 11140. 4.4 Class 3: single variable indicators A single variable indicator shall be designed to react to one of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization process at a stated value (SV) of the chosen variable (see 5.7 and 5.8). 4.5 Class 4: multi-variable indicators A multi-variable indicator shall be designed to react to two or more of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization cycle at SVs of the chosen variables (see 5.7 and 5.8). kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) 4 © ISO 2005 – All rights reserved 4.6 Class 5: integrating indicators Integrating indicators shall be designed to react to all critical variables. The SVs are generated to be equivalent to, or exceed the performance requirements given in the ISO 11138 series for BIs (see Clauses 11, 12 and 13). 4.7 Class 6: emulating indicators Emulating indicators are cycle verification indicators which shall be designed to react to all critical variables for specified sterilization cycles. The SVs are generated from the critical variables of the specified sterilization process. 5 General requirements 5.1 The requirements given in this clause shall apply to all indicators unless specifically excluded or amended in a subsequent clause or part of ISO 11140. 5.2 For the different sterilization processes, the following variables are defined as being critical: • STEAM Time, temperature and water (as delivered by saturated steam) • DRY HEAT Time and temperature • ETHYLENE OXIDE Time, temperature, relative humidity and ethylene oxide (EO) concentration • IRRADIATION Total absorbed dose • STEAM-FORMALDEHYDE Time, temperature, water (as delivered by saturated steam) and formaldehyde concentration • VAPOURIZED Time, temperature, hydrogen peroxide concentration, and, if applicable,
HYDROGEN PEROXIDE plasma 5.3 The manufacturer shall establish, document and maintain a formal quality system to cover all operations required by this part of ISO 11140. NOTE ISO 9001 and ISO 13485 describe requirements for quality systems for design, manufacture and testing. 5.4 Each indicator shall be clearly marked with the type of process for which it is intended to be used (see 5.6 and 5.7), with the the class of indicator (see Clause 4), and for Class 3, 4, 5 and 6 indicators, with the the SVs. Where the size or format of the indicator does not permit this information to be stated in a font of 6 characters per centimetre or larger, the information shall be provided on the label and/or instructions for use. 5.5 The indicator shall comply with the requirements of this part of ISO 11140 for the duration of the shelf life as specified by the manufacturer (see Annex A). kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 55.6 Abbreviated descriptions of the process shall be in accordance with the following symbols:
STEAM all steam sterilization processes
DRY all dry heat sterilization processes
EO all ethylene oxide sterilization processes
IRRAD all ionizing radiation sterilization processes
FORM all steam/formaldehyde sterilization processes
VH2O2 all vaporized hydrogen peroxide sterilization processes These descriptions are symbols and should not be translated. 5.7 If the indicator is designed for use in specific sterilization cycles, this information shall be stated or coded on the indicator, e.g.
STEAM 121 °C 15 min
(See 3.12 and 5.6.) 5.8 Each package of indicators or the technical information leaflet supplied with the package shall provide the following information: a) the change that is intended to occur; and for colour change indicators where the colour change cannot be adequately described, samples of the expected colour range for both changed and unchanged indicators; b) the critical variable(s) to which the indicator will respond, and where applicable, their SVs; c) the class (see Clause 4), process (see 5.6) and intended use (see 5.7) for which the indicator is designed; d) the storage conditions, before and after use; e) the expiry date, or the manufacturing date plus shelf life, under the specified storage conditions, expressed in accordance with ISO 8601 (e.g. YYYY-MM); f) a unique code (e.g. lot number) to provide traceability; kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) 6 © ISO 2005 – All rights reserved g) instructions for use essential to ensure proper functioning of the indicator; h) any interfering substances that are likely to be encountered, or conditions that are likely to occur, during the intended use of the indicator and which are known to affect adversely the performance of the indicator; i) any safety precautions required during and/or after use; j) the manufacturer's or supplier's name and address; k) the nature of any change that can occur when completely/incompletely changed indicators are stored according to the manufacturer’s instructions. NOTE National or regional regulations could contain additional or different requirements. 5.9 The manufacturer shall retain documentary evidence that the indicator, when used as intended by the manufacturer, does not release any substance known to be toxic in sufficient quantities to cause either a health hazard, or a hazard to the intended properties of the product being sterilized before, during or after the sterilization process for which it is designated. 6 Performance requirements 6.1 General 6.1.1 The condition of the indicator after exposure to a sterilization process, during which all the variables met or exceeded the specified level to produce a visible change, graduated response or endpoint, shall remain unchanged for a period of not less than six months from the date of use, when stored under the conditions specified by the indicator manufacturer. 6.1.2 Incompletely changed indicators can deteriorate on storage, either returning to the unchanged condition or slowly completing the change reaction. If such deterioration can occur, this information should be stated in the technical information supplied by the manufacturer [see 5.8 k)]. 6.2 Class 1 Indicators 6.2.1 The visible change that occurs after exposure of the indicator shall be clearly observable and shall be either from light to dark, dark to light, or shall be from one colour to a distinctly different colour (see Clause 8). 6.2.2 When printed on to single-use packaging material complying with ISO 11607, the indicator agent shall not bleed or offset to such an extent that it compromises the utility of the indicator or presents a hazard for the use of the packaging material. Penetration shall not occur before, during or after the sterilization process for which it is designed, when tested according to the method given in 7.2 (see also 5.9). 6.3 Class 2 indicators Specific requirements for Class 2 indicators are given in Parts 3, 4 and 5 of ISO 11140. 6.4 Classes 3, 4, 5 and 6 indicators 6.4.1 The endpoint which occurs after exposure of the indicator to the SVs of critical variables shall be clearly observable and shall be either from light to dark, dark to light or shall be from one colour to a distinctly different colour. 6.4.2 The indicator agent shall not off-set or penetrate the substrate to which it is applied, or materials with which it is in contact before, during or after the sterilization process for which it is designed, when tested according to the method given in 7.2 (see also 5.9). kSIST prEN ISO 11140-1:2009
ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 77 Test methods 7.1 General Tests for compliance with the requirements given in Clauses 6 and 7 to 14 of this part of ISO 11140 shall be carried out by exposing the indicators to the conditions specified and using equipment complying with ISO 18472, then examining the indicator for compliance. Specific test methods for irradiation indicators are not given. Performance requirements are given in 8.5. NOTE Test equipment and methods for Class 2 indicators are contained in Parts 3, 4 and 5 of ISO 11140. 7.2 Off-set (transference) Place a second layer of a similar substrate to that of the indicator in intimate contact with the indicator reagent. Process the indicator in the sterilization process, as stated by the indicator manufacturer. Visually inspect the indicator, its substrate and the second layer of substrate, before and after processing, for compliance with 6.2.2 or 6.4.2. 7.3 Procedure — Steam indicators 7.3.1 Load the indicator on to a suitable sample holder. The sample holder shall not affect the performance of the indicator. The sample holder should allow the indicator to be exposed to the test conditions in the manner specified by the indicator manufacturer. Different indicators may require different sample holder designs. Consult the indicator manufacturer for guidance. 7.3.2 Before initiating a test cycle, the inner surface of the resistometer shall be heated to the required temperature. 7.3.3 With the loaded sample holder in the resistometer, carry out the following sequence of operations: a) Evacuate the resistometer to 4,5 kPa ± 0,5 kPa within 2 min [manufacturers of chemical indicators may choose to specify the use of a different depth
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