SIST EN ISO 11138-5:2006

SLOVENSKI STANDARD
SIST EN ISO 11138-5:2006
01-september-2006
1DGRPHãþD
SIST EN 866-5:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 5. del: Biološki
indikatorji za sterilizacijske postopke s paro nizke temperature in formaldehidom
(ISO 11138-5:2006)
Sterilization of health care products - Biological indicators - Part 5: Biological indicators
for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 5:
Biologische Indikatoren für Sterilisationsverfahren mit Niedertemperatur-Dampf-
Formaldehyd (ISO 11138-5:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 5: Indicateurs
biologiques pour la stérilisation a la vapeur d'eau et au formaldéhyde a basse
température (ISO 11138-5:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-5:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-5:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-5:2006

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SIST EN ISO 11138-5:2006
EUROPEAN STANDARD
EN ISO 11138-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-5:1999
English Version
Sterilization of health care products - Biological indicators - Part
5: Biological indicators for low-temperature steam and
formaldehyde sterilization processes (ISO 11138-5:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 5: Indicateurs biologiques pour la stérilisation à la Biologische Indikatoren - Teil 5: Biologische Indikatoren für
vapeur d'eau et au formaldéhyde à basse température (ISO Sterilisationsverfahren mit Niedertemperatur-Dampf und
11138-5:2006) Formaldehyd (ISO 11138-5:2006)
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 11138-5:2006: E
worldwide for CEN national Members.

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SIST EN ISO 11138-5:2006

EN ISO 11138-5:2006 (E)





Foreword


This document (EN ISO 11138-5:2006) 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 866-5:1999.

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 11138-5:2006 has been approved by CEN as EN ISO 11138-5:2006 without any
modifications.

2

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SIST EN ISO 11138-5:2006


INTERNATIONAL ISO
STANDARD 11138-5
First edition
2006-07-01

Sterilization of health care products —
Biological indicators —
Part 5:
Biological indicators for low-temperature
steam and formaldehyde sterilization
processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 5: Indicateurs biologiques pour la stérilisation à la vapeur d'eau et
au formaldéhyde à basse température




Reference number
ISO 11138-5:2006(E)
©
ISO 2006

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SIST EN ISO 11138-5:2006
ISO 11138-5:2006(E)
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ii © ISO 2006 – All rights reserved

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SIST EN ISO 11138-5:2006
ISO 11138-5:2006(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 11138-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
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 2006 – All rights reserved iii

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SIST EN ISO 11138-5:2006
ISO 11138-5:2006(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 sterilization processes. This part of 11138 gives specific requirements for those biological
indicators intended for use in low-temperature steam and formaldehyde 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 that
are known to be in use today.
Standards exist providing general requirements for the validation and control of low-temperature steam and
1)
formaldehyde sterilization (see ISO 14937) .
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.


1) Although ISO/TC 198 has agreed to develop a standard applicable to dry heat processes, it was not available for
reference at the time this document was prepared.
iv © ISO 2006 – All rights reserved

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SIST EN ISO 11138-5:2006
INTERNATIONAL STANDARD ISO 11138-5:2006(E)

Sterilization of health care products — Biological indicators —
Part 5:
Biological indicators for low-temperature steam and
formaldehyde 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
...