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 —
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Partie 1: Exigences générales
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ISO 11140-1:2005
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Reference number
ISO 11140-1:2005(E)
© ISO 2005
ISO 11140-1:2005(E)
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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 iTeh STANDARD PREVIEW
Additional requirements for steam integrating (Class 5) indicators ............................................. 14
12 Additional requirements(standards.iteh.ai)
for dry heat integrating (Class 5) indicators ......................................... 14
13 Additional requirements for ethylene oxide integrating (Class 5) indicators .............................. 15
14
ISO 11140-1:2005
Additional requirements for emulating (Class 6) indicators .......................................................... 16
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Annex A (informative) Method for demonstrating shelf life of the product ............................................... 17
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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
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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
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ISO 11140-1:1995/Amd.1:1998), which has been technically revised.
(standards.iteh.ai)
ISO 11140 consists of the following parts, under the general title Sterilization of health care products —
Chemical indicators:
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Part 1: General requirements
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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.
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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.
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Resistometers (see ISO 18472) are (standards.iteh.ai)
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 ISO
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attempt to duplicate resistometer conditions, erroneous and/or
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misleading results may occur.
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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.
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NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the
(standards.iteh.ai)
demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for
biological indicators (BIs).
ISO 11140-1:2005
1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in
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subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which
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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.
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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) iTeh STANDARD PREVIEW
NOTE An indicator system in combination(standards.iteh.ai)
with a specific test load is also termed an indicator.
3.6 ISO 11140-1:2005
indicator agent/indicator reagent
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active substance(s) or combination of substances (see Annex E)
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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
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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
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In subsequent parts of ISO 11140, indicators are classified by their intended use. The chemical indicators
(standards.iteh.ai)
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
ISO 11140-1:2005
when used as defined by the manufacturer. This classification has no hierarchical significance.
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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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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 iTeh
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temperature, relative humidity and ethylene oxide (EO)
concentration
• IRRADIATION
(standards.iteh.ai)
Total absorbed dose
ISO 11140-1:2005
• STEAM-FORMALDEHYDE Time, temperature, water (as delivered by saturated steam) and
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formaldehyde concentration
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• 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).
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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
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VH2O2
(standards.iteh.ai)
all vaporized hydrogen peroxide sterilization processes
ISO 11140-1:2005
These descriptions are symbols and should not be translated.
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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;
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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
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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
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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.
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6.1.2 Incompletely changed indicators can deteriorate on storage, either returning to the unchanged
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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).
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