EN ISO 11138-3:2006

SLOVENSKI STANDARD
01-oktober-2006
1DGRPHãþD
SIST EN 866-3:2000
SIST EN 866-7:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki
indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2006)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators
for moist heat sterilization processes (ISO 11138-3:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3:
Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs
biologiques pour la stérilisation a la chaleur humide (ISO 11138-3:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-3:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11138-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-3:1997, EN 866-7:1999
English Version
Sterilization of health care products - Biological indicators - Part
3: Biological indicators for moist heat sterilization processes
(ISO 11138-3:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 3: Indicateurs biologiques pour la stérilisation à la Biologische Indikatoren - Teil 3: Biologische Indikatoren für
chaleur humide (ISO 11138-3:2006) Sterilisationsverfahren mit feuchter Hitze (ISO 11138-
3:2006)
This European Standard was approved by CEN on 7 June 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-3:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11138-3:2006) 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 January 2007, and conflicting national standards
shall be withdrawn at the latest by January 2007.

This document supersedes EN 866-3:1997, EN 866-7:1999.

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 EU Directive(s).

For relationship with EU Directive(s), 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, 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.

Endorsement notice
The text of ISO 11138-3:2006 has been approved by CEN as EN ISO 11138-3:2006 without any
modifications.
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 one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices: General.

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 normative clauses of this standard confers, within the limits of the scope of this standard, a
presumption of conformity with the relevant Essential Requirements of that Directive and
associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 11138-3
Second edition
2006-07-01
Sterilization of health care products —
Biological indicators —
Part 3:
Biological indicators for moist heat
sterilization processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur humide

Reference number
ISO 11138-3:2006(E)
©
ISO 2006
ISO 11138-3:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 11138-3:2006(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 11138-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11138-3:1995), which has been technically
revised.
ISO 11138 consists of the following parts, under the general title Sterilization of health care products —
Biological indicators:
⎯ Part 1: General requirements
⎯ Part 2: Biological indicators for ethylene oxide sterilization processes
⎯ Part 3: Biological indicators for moist heat sterilization processes
⎯ Part 4: Biological indicators for dry heat sterilization processes
⎯ Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11138-3:2006(E)
Introduction
ISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture
of biological indicators including inoculated carriers and suspensions intended for use in validation and
monitoring of sterilization processes. This part of ISO 11138 gives specific requirements for those biological
indicators intended for use in moist heat sterilization processes.
The intent of providing requirements in the ISO 11138 series of International Standards is to provide general
requirements and requirements for test methods. This series of International Standards represents the current
“state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities
involved in developing the standard. The intent is not to promote the use of biological indicators where such
use is not advised, but to provide common requirements for the production of those biological indicators
known to be in use today.
Standards exist providing requirements for the validation and control of moist heat sterilization
(see ISO 17665).
NOTE Some countries or regions may have published standards covering requirements for sterilization or biological
indicators.
Advice on selection, use and interpretation of results when using biological indicators can be found in
ISO 14161.
iv © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 11138-3:2006(E)

Sterilization of health care products — Biological indicators —
Part 3:
Biological indicators for moist heat sterilization processes
1 Scope
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers,
biological indicators and test methods intended for use in assessing the performance of sterilization processes
employing moist heat as the sterilizing agent.
Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam
mixtures may be used in moist heat sterilization processes, the methods and performance requirements of
this part of ISO 11138 might not be applicable for biological indicators used in such processes.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.
NOTE 2 National or regional regulations may provide requirements for work place safety.
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 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General
requirements
ISO 18472, Sterilization of health care products — Biolgical and chemical indicators — Test equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11138-1 apply.
4 General requirements
The requirements of ISO 11138-1 apply.
ISO 11138-3:2006(E)
5 Test organism
5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganism
of demonstrated equivalent performance as required by this part of ISO 11138.
NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.
NOTE 2 Geobacillus stearothermophilus ATCC 7953 (NCTC 10007, DSM 22 and CIP 52.81), ATCC 12980 (equivalent
to NRRL B-4419), have been found to be suitable.
5.2 If a test organism other than Geobacillus stearothermophilus or Bacillus subtilis ATCC 35021 (5230) is
used, the suitability of the resistance of that test organism shall be determined.
NOTE For processes at less than 121 °C, microorganisms such as Bacillus subtilis ATCC 35021 (5230) could be
used, particularly in sterilization of heat-sensitive liquids.
6 Suspension
The requirements of ISO 11138-1 apply.
7 Carrier and primary packaging
7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in moist
heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2006,
5.2 and Annex B.
7.2 The exposure conditions for establishing compliance shall be:
a) minimum exposure temperature: W 5 °C above the manufacturer’s stated maximum temperature;
b) sterilizing agent: dry saturated steam; if the biological indicator is intended for use in a moist heat process
not using dry saturated steam, e.g. an air/steam mixture, the appropriate air steam mixture should be
used and noted as an exception to this part of ISO 11138;
c) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, a
temperature of 140 °C shall be used;
d) exposure time: W 30 min.
NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the
practical limits
...