ISO 11140-3:2000
(Main)Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicators for steam penetration test sheets
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicators for steam penetration test sheets
Stérilisation des produits de santé — Indicateurs chimiques — Partie 3: Indicateur de classe 2 utilisé lors de l'essai de pénétration de la vapeur
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11140-3
First edition
2000-09-01
Sterilization of health care products —
Chemical indicators —
Part 3:
Class 2 indicators for steam penetration
test sheets
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 3: Indicateurs de classe 2 pour draps servant à l'essai de pénétration
de la vapeur
Reference number
ISO 11140-3:2000(E)
©
ISO 2000
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ISO 11140-3:2000(E)
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ISO 11140-3:2000(E)
Contents Page
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 General requirements.2
5 Indicator system format .2
6 Performance requirements.2
7 Packaging and labelling.3
8 Quality assurance.5
Annex A (normative) Determination of strength after steam sterilization .6
Annex B (normative) Estimation of visual difference between colour of the substrate and the changed
(or unchanged) indicator system by determination of relative reflectance density.7
Annex C (normative) Determination of indicator colour change on exposure to dry saturated steam.11
Annex D (normative) Determination of indicator colour change on exposure to dry heat .12
Annex E (normative) Ageing of test samples.13
Annex F (normative) Evaluation of transfer of indicator to standard test pack on processing .14
Annex G (normative) Determination of shelf life of the product .15
Annex H (normative) Steam exposure apparatus.16
Annex I (normative) Determination of sensitivity of the indicator to the presence of air .18
Annex J (normative) Air injection system .19
Annex K (normative) Standard test pack.21
Bibliography.22
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ISO 11140-3:2000(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 3.
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 part of ISO 11140 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11140-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care
products.
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
Annexes A through K form a normative part of this part of ISO 11140.
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ISO 11140-3:2000(E)
Introduction
This part of ISO 11140 is based on EN 867-3, Non-biological systems for use in sterilizers — Part 3: Specification
for Class B indicators for use in the Bowie and Dick test.
The Bowie and Dick test was conceived as a test for successful air removal from high-vacuum porous-load
sterilizers used in the sterilization of health care products [1]. A successful Bowie and Dick test indicates rapid and
even penetration of steam into the test pack. The presence of air within the pack, due either to an inefficient air
removal stage, an air leak during this stage or non-condensable gases in the steam supply, are circumstances
which can lead to failure of the test. The result of the test may also be affected by other factors which inhibit steam
penetration. The test does not necessarily demonstrate either achievement of the required temperature or
maintenance of that temperature for the required time to achieve sterilization.
A failure of the Bowie and Dick test is not conclusive proof that the fault in the sterilizer is due to air retention, air
leakage or non-condensable gases and it can be necessary to investigate other causes of failure.
The Bowie and Dick test is a performance test for steam sterilizers for wrapped goods and porous loads. As such it
is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine test of
performance in EN 554. The test method is described in EN 285.
A test pack for the Bowie and Dick test consists of two components:
a) a small standardized test load, and
b) a chemical indicator to detect the presence of steam.
The Bowie and Dick test as originally described [1] utilized huckaback towels as the material for the test load. The
test as described in EN 285 uses cotton sheets for this purpose.
Because a range of different tests in different countries have historically been termed the Bowie and Dick test, no
reference to this term, other than in this Introduction, is used in this part of ISO 11140.
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INTERNATIONAL STANDARD ISO 11140-3:2000(E)
Sterilization of health care products — Chemical indicators —
Part 3:
Class 2 indicators for steam penetration test sheets
1 Scope
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test
for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a
Class 2 indicator as described in ISO 11140-1.
Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as
described in EN 285. This part of ISO 11140 does not detail requirements for the standard test pack, but specifies
the performance of the indicators.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11140. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11140 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 5-1, Photography — Density measurements — Part 1: Terms, symbols and notations.
ISO 5-3, Photography — Density measurements — Part 3: Spectral conditions.
ISO 5-4:1995, Photography — Density measurements — Part 4: Geometric conditions for reflection density.
ISO 187:1990, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for
monitoring the atmosphere and conditioning of samples.
ISO 2248, Packaging — Complete, filled transport packages — Vertical impact test by dropping.
ISO 5457, Technical drawings — Sizes and layout of drawing sheets.
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method.
ISO 9001:1994, Quality systems — Model for quality assurance in design, development, production, installation
and servicing.
ISO 11140-1:1995, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
EN 285:1996, Sterilization — Steam sterilizers — Large sterilizers.
1)
CIE 15.2–1986, Colorimetry.
1)
International Commission on illumination, Vienna, Austria.
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ISO 11140-3:2000(E)
3 Terms and definitions
For the purposes of this part of ISO 11140, the terms and definitions given in ISO 11140-1 and EN 285 apply.
4 General requirements
4.1 The requirements of ISO 11140-1 apply.
4.2 Test samples shall be conditioned in accordance with ISO 187 prior to testing for performance.
5 Indicator system format
The indicator system format shall meet the following requirements.
a) It shall consist of indicator reagent uniformly distributed on a substrate to cover not less than 30 % of the
surface area of the substrate. The distance between adjacent areas of indicator reagent shall not exceed
20 mm.
NOTE The pattern of indicator reagent distribution should permit easy comparison of the colour change at the margin
with the colour change in the central region.
.
b) It shall have an air porosity greater than 3,4 �m/(Pa s) when tested in accordance with ISO 5636-3 at an air
pressure of 1,47 kPa.
c) It shall have sufficient strength to withstand steam sterilization.
Compliance shall be tested in accordance with annex A.
d) It shall have a substrate of a colour which is uniform to visual observation.
e) It shall have a difference in reflectance density of not less than 0,3 between the substrate and either the
changed indicator or the unchanged indicator as specified by the manufacturer.
Compliance shall be tested in accordance with annex B.
f) It shall permit writing in permanent ink to be made legibly on both processed and unprocessed materials.
Markings made before processing shall be legible after processing.
g) It shall be A4 size in accordance with ISO 5457.
6 Performance requirements
6.1 The indicator shall meet the following requirements.
a) It shall show a uniform colour change complying with 5 e) after exposure to dry saturated steam at
(134 +1,5/0) °C for 3,5 min� 5 s or after exposure to dry saturated steam at (121 + 1,5/0) °Cfor 15min�5s
or both.
Compliance shall be tested in accordance with annex C.
b) When placed in the centre of a standard test pack, it shall show a non-uniform colour change when the
temperature at the centre of the standard test pack is 2 K lower than the temperature of the chamber drain of
the steam exposure apparatus (see annex H).
Compliance shall be tested in accordance with annex I.
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ISO 11140-3:2000(E)
c) It shall show no discernible colour change after exposure to dry heat at (140� 2) °C for not less than 30 min.
Compliance shall be demonstrated in accordance with annex D.
With some indicators a slight colour change can occur. This shall be acceptable if the change that occurs is
slightly or markedly different from that brought about by exposure to steam in accordance with 6.1 a) and
within the limits specified by the manufacturer.
d) It shall not visibly transfer indicator reagent to the material of the test load in intimate contact with the indicator
during processing.
Compliance shall be demonstrated in accordance with annex F.
6.2 The indicator shall comply with the requirements of this standard for the duration of the shelf life specified by
the manufacturer.
If any change in the indicator occurs during ageing, it shall be different to the change on exposure to dry saturated
steam [as described in 6.1 a)] and have either inactivated the indicator so that no further change can take place or
not affected the performance of the indicator with respect to the requirements of 6.1 a) and 6.1 b).
Compliance shall be tested in accordance with annex G or by performance testing after accelerated ageing in
accordance with annex E.
7 Packaging and labelling
7.1 Each substrate on which an indicator reagent has been deposited shall be marked with the operating
temperature(s) for which the product is designed to be used.
7.2 Each indicator shall be marked with a unique code from which the manufacturing history can be traced, and
at least the information given below.
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ISO 11140-3:2000(E)
Site
Machine No.
Date
Supervisor
Department
Operator
Result
NOTE Other formats can be used.
Figure 1 — Example of a suitable format
7.3 Each indicator shall be provided with space for the user to record essential cycle information under the
headings:
a) Department;
b) Machine No.;
c) Cycle No.;
d) Operator;
e) Date;
f) Result;
g) Supervisor.
Adjacent to each heading there shall be a clear space not less than 5 mm� 20 mm for the user to enter the
required information at the time of use. See Figure 1.
7.4 The product shall be packed in such a way as to allow easy separation of individual units of product and to
protect the product from moisture, dust, sunlight and damage in normal transit, to the extent necessary to ensure
that the indicator retains its performance throughout the stated shelf-life when stored in accordance with the
manufacturer's instructions.
The manufacturer shall retain documentary evidence demonstrating compliance.
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ISO 11140-3:2000(E)
7.5 The outside of each carton shall be marked with the operating temperature at which the product is suitable
for use.
7.6 The information supplied by the manufacturer (see 5.6 of 11140-1:1995) shall include sufficient instruction on
the use of the indicator to enable correct interpretation of the test results.
8 Quality assurance
8.1 The quality system shall ensure that an acceptable quality level (AQL) of 1,0 or less is maintained for
performance requirements given in 6.1 a) and 6.1 b).
NOTE The AQL is the maximum number of defects per hundred units that, for the purpose of sampling inspection, can be
considered satisfactory as a process average.
8.2 Suitable records shall be maintained to ensure that, in the event of a defect arising, faulty batches can be
recalled from use.
8.3 The manufacturing and distribution records shall be retained for a period of five years or twice the declared
shelf life of the product, whichever is the less. These records shall be maintained in accordance with the
requirements of 4.16 of ISO 9001:1994.
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ISO 11140-3:2000(E)
Annex A
(normative)
Determination of strength after steam sterilization
A.1 Apparatus
A.1.1 Steam exposure apparatus complying with annex H.
A.1.2 Standard test pack complying with annex K.
A.1.3 Steam supply complying with 13.3.2 to 13.3.4 of EN 285:1996.
A.2 Procedure
A.2.1 Expose the indicator, within a standard test pack, to three successive steam exposures at the stated
operating temperature of the indicator system.
A.2.2 Remove the standard test pack from the exposure apparatus and perform a drop test in accordance with
ISO 2248 from a height of 1 m onto a firm horizontal surface.
NOTE Concrete or terrazzo surfaces are suitable.
A.2.3 Remove the indicator from the standard test pack and visually examine for damage.
A.2.4 Repeat this test for each of three separate production batches of the indicator system.
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ISO 11140-3:2000(E)
Annex B
(normative)
Estimation of visual difference between colour of the substrate and the
changed (or unchanged) indicator system by determination of relative
reflectance density
B.1 Apparatus
B.1.1 Steam exposure apparatus complying with annex H.
B.1.2 Photoelectric reflectance photometer complying with the requirements of B.3.2.
B.2 Principle
The relative reflectance density, D as defined in ISO 5-1, of the changed indicator and the substrate are
,
Rf
determined in accordance with the methods given below, which are based on ISO 5-3 and ISO 5-4, to which
reference shall also be made.
D = – log R
Rf 10 f
R =� /�
f c ce
where
� is the reflected flux from the indicator and
c
� is the reflected flux from the substrate.
ce
To completely define a type of density spectrally, it is necessary to specify the light source, optics and spectral
response of the measuring system.
B.3 Measurement
B.3.1 Illumination
The relative spectral power distribution of the incident flux shall conform to CIE standard illuminant D ,in
65
accordance with CIE 15.2.
NOTE This is regarded as equivalent to “Daylight - cloudy northern sky”.
B.3.2 Measuring instrument
B.3.2.1 General
The measuring instrument shall be a photoelectric instrument giving within 0,3 %
...
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