SIST EN ISO 15882:2008

SLOVENSKI STANDARD
SIST EN ISO 15882:2008
01-november-2008
1DGRPHãþD
SIST EN ISO 15882:2003
Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - Navodilo za
izbiro, uporabo in predstavitev rezultatov (ISO 15882:2008)
Sterilization of health care products - Chemical indicators - Guidance for selection, use
and interpretation of results (ISO 15882:2008)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren -
Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO
15882:2008)
Stérilisation des produits de santé - Indicateurs chimiques - Directives pour la sélection,
l'utilisation et l'interprétation des résultats (ISO 15882:2008)
Ta slovenski standard je istoveten z: EN ISO 15882:2008
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 15882:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15882:2008

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SIST EN ISO 15882:2008
EUROPEAN STANDARD
EN ISO 15882
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2008
ICS 11.080.01 Supersedes EN ISO 15882:2003
English Version
Sterilization of health care products - Chemical indicators -
Guidance for selection, use and interpretation of results (ISO
15882:2008)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Directives pour la sélection, l'utilisation et l'interprétation Chemische Indikatoren - Leitfaden für die Auswahl,
des résultats (ISO 15882:2008) Verwendung und Interpretation von Ergebnissen (ISO
15882:2008)
This European Standard was approved by CEN on 24 August 2008.
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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15882:2008: E
worldwide for CEN national Members.

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SIST EN ISO 15882:2008
EN ISO 15882:2008 (E)
Contents Page
Foreword.3

2

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SIST EN ISO 15882:2008
EN ISO 15882:2008 (E)
Foreword
This document (EN ISO 15882:2008) 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 March 2009, and conflicting national standards shall be withdrawn at
the latest by March 2009.
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 15882:2003.
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 15882:2008 has been approved by CEN as a EN ISO 15882:2008 without any modification.

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SIST EN ISO 15882:2008

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SIST EN ISO 15882:2008

INTERNATIONAL ISO
STANDARD 15882
Second edition
2008-09-01

Sterilization of health care products —
Chemical indicators — Guidance for
selection, use and interpretation of
results
Stérilisation des produits de santé — Indicateurs chimiques —
Directives pour la sélection, l'utilisation et l'interprétation des résultats




Reference number
ISO 15882:2008(E)
©
ISO 2008

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SIST EN ISO 15882:2008
ISO 15882:2008(E)
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©  ISO 2008
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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ii © ISO 2008 – All rights reserved

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SIST EN ISO 15882:2008
ISO 15882:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 General considerations. 3
4 Classes of chemical indicator . 5
4.1 General. 5
4.2 Class 1: Process indicators. 5
4.3 Class 2: Indicators for use in specific tests. 6
4.4 Class 3: Single variable indicators . 6
4.5 Class 4: Multi-variable indicators. 8
4.6 Class 5: Integrating indicators . 8
4.7 Class 6: Emulating indicators . 9
5 Selection of chemical indicators. 10
6 Use of chemical indicators . 10
6.1 Class 1 process indicators . 10
6.2 Class 2 indicators . 11
6.3 Class 3, 4, 5 and 6 indicators. 11
6.4 Indicators for use with process challenge devices. 11
7 Interpretation of results from chemical indicators. 12
7.1 General. 12
7.2 Chemical indicator responses. 12
7.3 Chemical indicators showing “fail” response . 12
8 Chemical indicators in sterility assurance procedures. 12
8.1 General. 12
8.2 Record keeping . 13
9 Personnel training . 13
10 Storage and handling . 14
11 Labelling . 14
11.1 General. 14
11.2 Indicator marking. 14
11.3 Process marking. 14
11.4 Package marking . 14
Annex A (informative) Background on the Bowie and Dick test . 16
Annex B (informative) Explanation of the terms “parameter” and “variable” . 19
Annex C (informative) Rationale for the requirements for integrating indicators and the link to the
requirements for biological indicators (BIs) specified in the ISO 11138 series and
microbial inactivation (derived from ISO 11140-1) . 20
Annex D (informative) Specifications for porosity. 27
Annex E (informative) Figure showing relationship of indicator components. 29
Bibliography . 30

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SIST EN ISO 15882:2008
ISO 15882:2008(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 15882 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 15882:2003) which has been technically
revised.
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SIST EN ISO 15882:2008
ISO 15882:2008(E)
Introduction
This International Standard provides guidance for users regarding the selection, use and interpretation of
results of chemical indicators intended for use with sterilization processes employing steam, dry heat,
ethylene oxide, γ or β radiation, low temperature steam and formaldehyde (LTSF), or vapourized hydrogen
[13] [12], [13], [14], [15], [16]
peroxide as documented in ISO 11140-1 . The ISO 11140 series of standards specifies
performance requirements for chemical indicators. These standards are intended primarily for the use of
manufacturers of chemical indicators. The guidance in this document is of a general nature; chemical
indicators do not, of themselves, constitute a comprehensive monitoring programme with regard to the
sterilization of health care products. Users' attention is drawn to the requirements for validation of sterilization
[18] [19], [20]
processes specified in ISO 14937 for general processes, the ISO 17665 series for moist heat
[5], [6] [7]
sterilization, the ISO 11135 series for ethylene oxide sterilization, ISO 11137-1 for radiation
[22]
sterilization and ISO 20857 for dry heat sterilization.
The actual use/frequency of chemical indicators might be regulated by international and or national standards
as well as by local regulatory authorities.
The need for convenient and rapid means of detecting sterilization problems occurring during sterilization
processes has brought about the development of sterilization process monitors generally referred to as
“chemical indicators.” In this International Standard, users will find guidance on selection of the correct
chemical indicator for their particular sterilization process and critical parameters as well as guidance on its
appropriate use. The complexity of modern medical technology and the wide variety of sterilization processing
techniques and equipment available have made effective sterility assurance programmes more challenging
than ever before.

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SIST EN ISO 15882:2008

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SIST EN ISO 15882:2008
INTERNATIONAL STANDARD ISO 15882:2008(E)

Sterilization of health care products — Chemical indicators —
Guidance for selection, use and interpretation of results
1 Scope
1.1 This International Standard provides guidance for the selection, use and interpretation of results
of chemical indicators used in process definition, validation and routine monitoring and overall control
of sterilization processes. This International Standard applies to indicators that show exposure to
sterilization processes by means of physical and/or chemical change of substances, and which are
used to monitor one or more of the variables required of a sterilization process. These chemical
indicators are not dependent for their action on the presence or absence of a living organism.
1.2 This International Standard does not consider indicators for use in those processes that rely on
physical removal of microorganisms, e.g. filtration.
1.3 This International Standard is not intended to apply to indicators for use in combination
processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
[11]
NOTE A vocabulary of terms used for sterilization of health care products is provided in ISO/TS 11139 .
2.1
chemical indicator
non-biological indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or
physical change resulting from exposure to a process
[ISO/TS 11139, definition 2.6]
2.2
endpoint
point of the observed change as defined by the manufacturer occurring after the indicator has been
exposed to specified stated values
[ISO 11140-1, definition 3.3]
2.3
indicator
combination of the indicator agent and its substrate in the final form in which it is intended to be used
[ISO 11140-1 definition 3.5]
NOTE 1 An indicator system in combination with a specific test load is also termed an indicator.
NOTE 2 See Annex E.
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SIST EN ISO 15882:2008
ISO 15882:2008(E)
2.4
indicator agent
indicator reagent
active substance(s) or combination of substances
[ISO 11140-1, definition 3.6]
NOTE See Annex E.
2.5
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess
performance of the process
[ISO/TS 11139, definition 2.33]
2.6
process challenge location
PCL
site which represents “worst case” conditions as they are given for sterilizing agent(s) in the goods to
be sterilized
2.7
process parameter
specified value for a process variable
[ISO/TS 11139, definition 2.34]
NOTE 1 The specification for a sterilization process includes the process parameters and their tolerances.
NOTE 2 See Annex B.
2.8
process variable
condition within a sterilization process, changes in which alter microbicidal effectiveness
[ISO/TS 11139, definition 2.35]
EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength.
NOTE See Annex B.
2.9
resistometer
test equipment designed to create defined combinations of the physical and/or chemical parameters of a
sterilization process
2.10
saturated steam
water vapour in a state of equilibrium between condensation and evaporation
[ISO 11140-1 definition 3.11]
2.11
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
[ISO 11140-1, definition 3.12]
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SIST EN ISO 15882:2008
ISO 15882:2008(E)
2.12
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.
[ISO 11140-1, definition 3.15]
3 General considerations
3.1 All chemical indicators are intended to provide information about conditions at the location of the
indicator within the sterilizer, sterilizer load or PCD. This can alert the user to potential sterilization process
failures.
3.2 The value of the information provided by a chemical indicator is dependent upon the class of indicator,
number and location of the indicators, being representative of the conditions throughout the sterilizer chamber
or load. Representative locations for a load configuration should be identified during process validation studies.
3.3 The basic performance descriptors of any chemical indicator are its visible change, graduated response
or “endpoint” response. The endpoint response can, for example, involve either the melting of a chemical
substance or a chemical reaction resulting in a specified colour change.
3.4 A number of different classes of chemical indicators have been developed to suit different monitoring
needs and to provide information about the sterilization process. Some types are sensitive to certain specific
problems, such as a failure to attain a required temperature. Others might not respond only to a single
process variable, but might simultaneously respond to several process variables during the sterilization cycle.
Selection of the classes of chemical indicators that are best suited to a particular application should be made
only in the context of:
⎯ What characterizes effective sterilization?
⎯ Which problems could prevent sterilization?
⎯ What are the performance characteristics of the indicator(s)?
⎯ What constitutes effective sterility assurance activities during product release?
Once an indicator is selected, it will be of value in sterility assurance only if it is used and interpreted correctly,
and if the user takes appropriate action in response to the results.
3.5 Chemical indicators of the same class can differ in response characteristics and their means of
[13]
detecting exposure conditions. Chemical indicator classification in ISO 11140-1 is based on defined
performance characteristics (see, e.g., different stated values in that document) rather than on chemical or
physical changes as related to specific sterilization processes. For example, in a steam process, some
indicator types must be exposed to steam for a minimum length of time to achieve the endpoint, some must
be exposed to a minimum temperature, some are affected by a combination of temperature and time of
exposure, and still others are affected by time, temperature and saturated steam. In all cases, the user
compares the response of the chemical indicator to an endpoint described by the manufacturer.
If a chemical indicator fails to reach its endpoint, the facility should follow a documented protocol to investigate
the cause of the problem which could include, but not be limited to, the following items.
a) Was there a sterilizer malfunction that could account for the failure to achieve the endpoint?
b) Has there been a change(s) in the product and/or sterile barrier system?
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SIST EN ISO 15882:2008
ISO 15882:2008(E)
c) Has the loading density increased or decreased within the sterile barrier system?
d) Has the sterilization processing container/configuration changed (e.g. number of cartons has increased or
decreased, or the configuration was not the same as that used during validation)?
e) Was sterilizer calibration and/or routine maintenance conducted appropriately?
f) Was the correct sterilizer process chosen for the product sterilized?
g) Was the chemical indicator handled under manufacturer's recommended practices?
h) Have there been changes in the utilities supplied to the sterilizer that could materially affect cycle
execution (pressure, flow rate, non-condensable gases in the steam supply, etc.)?
NOTE For more information, the requirements and guidance provided in the specific process standards,
[20] [22] [7] [24] [25]
ISO/TS 17665-2 , ISO 20857 , ISO 11137-1 , EN 14180 and EN 15424 is valid.
[13]
3.6 Although other factors can influence the efficacy of a sterilization process, ISO 11140-1 identifies the
variables for each sterilization process in Table 1. A specific chemical indicator can respond to one, some, or
all of the variables, as indicated by its class (see Clause 5) and manufacturer's instructions for use.
If the use of the indicator is limited to a specific sterilization cycle, this information is stated or coded on the
product. For example, “STEAM 15 min 121 °C” means that the indicator is for use in a 15 min, 121 °C steam
sterilization cycle. The box around the word “STEAM” signifies that the indicator can only be used in the steam
sterilization process.
Table 1 — Variables for sterilization processes
a
Process Symbol Variables
Steam STEAM Time, temperature and water (as delivered by saturated steam)
Dry heat DRY Time and temperature
Ethylene oxide EO Time, temperature, humidity, and EO concentration
Irradiation IRRAD Total absorbed dose
Low temperature steam and FORM Time, temperature, water (as delivered by saturated steam) and
formaldehyde (LTSF) formaldehyde concentration
Vapourized hydrogen peroxide VH2O2 Time, temperature, hydrogen peroxide concentration, and, if
applicable, plasma
a
These are symbols and are not intended to be translated.
3.7 Class 3, 4, 5 and 6 indicators will have one or more stated value (SV) identified by the manufacturer.
These stated values identify the parameters that the indicator is designed to react to, and the level of
exposure required to achieve the stated visible change, graduated response or endpoint. Details of the SV will
be provided on the indicator, on the indicator packaging, or in information provided with the product. Visible
change is used to describe the response of class 1 process indicators. Graduated response is the progressive
observable change occurring on exposure to one or more process variables allowing assessment of the level
achieved.
The SV's are based on the outcome of tests carried out in a resistometer by a manufacturer.
[21]
The resistometer (ISO 18472 gives further information) is a test vessel that is designed for very rapid
attainment of the particular critical parameters of the sterilization process. These parameters are very closely
controlled during the exposure phase. Because sterilizers typically do not have the same response
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ISO 15882:2008(E)
characteristics or accuracy of exposure conditions as found in resistometers, it is very difficult for a user to
replicate manufacturer label claims using a sterilizer. Third party independent laboratories with resistometers
may be used to verify manufacturers' label claims. Since chemical indicators are tested at specific conditions,
inadvertent or intentional exposure to parameters (for example longer time, lower temperature and/or lower
sterilant concentration) outside of those specified by the manufacturer can lead to misleading results.
All chemical indicators in classes 3, 4, 5 and 6 have SV(s) at which they will reach their endpoints. A
sterilization process is defined by a minimum value with an upper limit, e.g. for a moist heat process a
minimum temperature is specified with an upper limit of + 3 °C. The SV(s) of the chemical indicator will
normally be linked to the minimum sterilization parameters for the process employed to process health care
products.
The response of the chemical indicator to a fail condition is verified by exposing the chemical indicators to
conditions lower than the SVs as specified in the accompanying tables.
4 Classes of chemical indicator
4.1 General
[13]
Chemical indicators are classified by their intended use. The chemical indicators described in ISO 11140-1
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 is
used 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.
Chemical indicators are used to detect whether or not certain critical process variables have reached a
predetermined level in a given sterilization process. The classification denotes the performance characteristics
and intended use of the indicator only.
The performance characteristics of each class enable the respective chemical indicators to convey different
types of information and therefore perform different functions.
All chemical indicators are based on either a chemical and/or physica
...