EN ISO 11138-1:2006

SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN 866-1:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne
zahteve (ISO 11138-1:2006)
Sterilization of health care products - Biological indicators - Part 1: General requirements
(ISO 11138-1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences
générales (ISO 11138-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-1:2006
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 11138-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-1:1997
English Version
Sterilization of health care products - Biological indicators - Part
1: General requirements (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 1: Exigences générales (ISO 11138-1:2006) Biologische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11138-1:2006)
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.
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© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11138-1:2006) 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 866-1:1997.

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 11138-1:2006 has been approved by CEN as EN ISO 11138-1:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11138-1
Second edition
2006-07-01
Sterilization of health care products —
Biological indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 1: Exigences générales
Reference number
ISO 11138-1:2006(E)
©
ISO 2006
ISO 11138-1:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 11138-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
1.1 General. 1
1.2 Exclusions . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General manufacturing requirements. 4
4.1 Manufacturing controls. 4
4.2 Test organism . 5
4.3 Information supplied by manufacturer (labelling). 6
4.4 Storage and transport . 6
5 Specific manufacturing requirements . 7
5.1 Suspensions. 7
5.2 Carrier, primary and secondary packaging . 7
5.3 Inoculated carrier. 8
5.4 Biological indicators. 8
5.5 Self-contained biological indicators. 8
6 Determination of resistance . 8
6.1 General resistance requirements. 8
6.2 Test organism . 9
6.3 Population of test organisms . 9
6.4 Resistance characteristics . 9
6.5 Test conditions . 10
7 Culture conditions . 10
7.1 Incubator. 10
7.2 Growth medium. 10
7.3 Incubation. 10
Annex A (normative) Determination of viable count . 11
Annex B (normative) Determination of growth inhibition by carriers and primary packaging
materials exposed to sterilization processes . 13
Annex C (normative) D value determination by survivor curve method . 15
Annex D (normative) D value determination by fraction negative method. 19
Annex E (normative) Survival-kill response characteristics . 35
Annex F (informative) Relationship between components of biological indicators . 36
Bibliography . 37

ISO 11138-1:2006(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 11138-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11138-1:1994), 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
iv © ISO 2006 – All rights reserved

ISO 11138-1:2006(E)
Introduction
This part of ISO 11138 specifies general requirements for 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. Subsequent parts of ISO 11138
provide additional specific requirements for biological indicators for defined sterilization processes.
A graphic description of a biological indicator and its components is presented in Annex F. The presentation
includes the two types of biological indicator which are covered by ISO 11138. This shows that inoculated
carriers can be presented directly to the sterilizing agent without prior packaging, or included in a primary
package that permits access by the sterilizing agent.
The resistance characteristics depend on the type of test organism, its numbers, the method of preparation
and the effects of the primary package. Advice on selection, use and interpretation of results of biological
[7]
indicators can be found in ISO 14161 .
For any individual sterilization process, including those covered in subsequent parts of ISO 11138, the
resistance of the biol
...