ISO 11138-2:1994

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization

Provides specific requirements for test organisms and biological indicators intended for use in assessing the performance of sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases at sterilizing temperatures within the range of 20 °C to 65 °C.

Stérilisation des produits de santé — Indicateurs biologiques — Partie 2: Indicateurs biologiques pour stérilisation à l'oxyde d'éthylène

General Information

• Status: Withdrawn
• Publication Date: 05-Oct-1994
• Withdrawal Date: 05-Oct-1994
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198/WG 4 - Biological indicators
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 26-Jun-2006

Relations

• Revised: ISO 11138-2:2006 - Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL
ISO
STANDARD 11138-Z
First edition
1994-I O-01
Sterilization of health tare products -
Biological indicators -
Part 2:
Biological indicators for ethylene oxide
sterilization
Stérilisation des produits sanitaires - Indicateurs biologiques -
Partie 2: Indicateurs biologiques pour stérilisation à l’oxyde d’éthylène
Reference number
ISO 11138-2:1994(E)

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ISO 11138-2:1994(E)
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
2 Normative reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 General
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Test organisms
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 Suspensions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .“. 2
7 Carrier and primat-y packaging
2
8 Biological indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
9 Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
10 Test methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annex
A Method for determination of resistance to ethylene oxide
3
sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 60 1994
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or utilized in anv form or bv anv means. electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Genève 20 l Switzerland
Printed in Switzerland
ii

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0 ISO
ISO II 138-2:1994(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.
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.
International Standard ISO 11138-2 was prepared by Technical Committee
ISO/TC 198, Sterilization of health tare products.
ISO 11138 consists of the following parts, under the general title
Sterilization of health tare products - Biological indicators:
- Part 1: General
- Part 2: Biological indicators for ethylene oxide sterilization
- Part 3: Biological indicators for moist hea t steriliza tion
Annex A forms an integral part of this part of ISO 11138.
. . .
III

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0 ISO
ISO 11138-2:1994(E)
Introduction
ISO 11138-I specifies general production, labelling and performance re-
quirements for the manufacture of biological indicators intended for use
as monitors of sterilization cycles, and this part of ISO 11 138 gives specific
requirements for ethylene oxide sterilization cycles. The procedures and
methods described should be carried out by suitably trained personnel.
Biological indicators are not intended for use in any process other than that
specified by the manufacturer on the labelling. The use of an inappropriate
biological indicator cari give misleading results.
Biological indicators should always be used in combination with physical
and/or chemical monitoring in demonstrating the efficacy of a sterilizing
process. When a physico-chemical variable of a sterilizing process is out-
side its specified limits, a sterilization cycle should always be regarded as
unsatisfactory, irrespective of the results obtained from biological indi-
cators.
The performance of a biological indicator cari be affected by the conditions
of storage prior to use, the methods of use or the techniques employed
after exposure to the process. For these reasons, the recommendations
of the manufacturer for storage and use should be followed and biological
indicators should be transferred to the specified recovery conditions as
soon as possible after exposure to the process. Biological indicators
should not be used beyond any expiry date stated by the manufacturer.
Biological indicators are used to test the effectiveness of sterilization
processes and equipment. These studies should be conducted by suitably
trained personnel.
iv

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INTERNATIONAL STANDARD 0 ISO ISO 11138-2:1994(E)
Sterilization of health tare products - Biological
indicators -
Part 2:
Biological indicators for ethylene oxide sterilization
1 Scope 4 General
This part of ISO 11138 provides specific requirements
The requirements of ISO 11138-I shall apply, except
for test organisms and biological indicators intended
as modified in subsequent clauses of this part of
for use in assessing the performance of sterilizers
ISO 11138.
employing pure ethylene oxide gas or admixtures of
the gas with diluent gases at sterilizing temperatures
within the range of 20 “C to 65 “C.
2 Normative reference
5 Test organisms
The following standard contains provisions which,
through reference in this text, constitute provisions
The test organisms shall be spores of Bacillus subtilis
of this part of ISO 11138. At the time of publication,
or other strains or organisms of demonstrated equiv-
the edition indicated was valid. All standards are sub-
alent performance as required by this part of
ject to revision, and parties to agreements based on
ISO 11138.
this part of ISO 11138 are encouraged to investigate
NOTE 1 Bacillus subtilis NCTC 10073 and CIP 7718, and
the possibility of applying the most recent edition of
B. subtilis ATCC 9372 have been found to be suitable.
the standard indicated below. Members of IEC and
ISO maintain registers of currently valid International
Standards.
ISO 11138-l :1994, Sterilizati
...