SIST EN ISO 11138-3:2009
(Main)Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
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.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2006)
Dieser Teil von ISO 11138 legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisationsverfahren vorgesehen sind, die feuchte Hitze als Sterilisiermittel anwenden.
Feuchte Hitze als Sterilisiermittel ist in diesem Teil der ISO 11138 als trockener gesättigter Dampf definiert. Bei Sterilisationsverfahren mit feuchter Hitze können Luft Dampf Gemische verwendet werden, die Verfahren und Leistungsanforderungen dieses Teils der ISO 11138 sind jedoch möglicherweise nicht für biologische Indikatoren anwendbar, die in solchen Verfahren verwendet werden.
ANMERKUNG 1 Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit feuchter Hitze sind in ISO 17665 festgelegt.
ANMERKUNG 2 Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen festgelegt sein.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur humide (ISO 11138-3:2006)
L'ISO 11138-3:2006 spécifie des exigences spécifiques pour les organismes d'essai, les suspensions, les porte-germes inoculés, les indicateurs biologiques et les méthodes d'essai utilisés dans l'évaluation des performances des procédés de stérilisation qui emploient la chaleur humide comme agent stérilisant.
Dans le cadre de l'ISO 11138-3:2006, la chaleur humide utilisée comme agent stérilisant est définie comme de la vapeur sèche saturée. Bien que les mélanges air-vapeur puissent être utilisés dans les procédés de stérilisation par chaleur humide, les méthodes et les exigences de performances décrites dans la présente partie de l'ISO 11138 peuvent ne pas être applicables aux indicateurs biologiques utilisés dans ces procédés.
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11138-3:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11138-3:2006
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 à la chaleur humide (ISO 11138-3:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-3:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11138-3:2009
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SIST EN ISO 11138-3:2009
EUROPEAN STANDARD
EN ISO 11138-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11138-3:2006
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 19 April 2009.
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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-3:2009: E
worldwide for CEN national Members.
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SIST EN ISO 11138-3:2009
EN ISO 11138-3:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 11138-3:2009
EN ISO 11138-3:2009 (E)
Foreword
The text of ISO 11138-3:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11138-3:2009 by 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11138-3:2006.
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 EC Directive.
For relationship with EC Directive, 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, Bulgaria, 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 the United Kingdom.
Endorsement notice
The text of ISO 11138-3:2006 has been approved by CEN as a EN ISO 11138-3:2009 without any
modification.
3
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SIST EN ISO 11138-3:2009
EN ISO 11138-3:2009 (E)
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 a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
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 clauses of this
standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA – Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4 5, 13 The requirements of
ISO 11138-1 apply
5.1 7.2, 7.3
7 7.3
9 10.1
WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the
scope of the standard."
4
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SIST EN ISO 11138-3:2009
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
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SIST EN ISO 11138-3:2009
ISO 11138-3:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11138-3:2009
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 2006 – All rights reserved iii
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SIST EN ISO 11138-3:2009
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 © I
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki indikatorji za sterilizacijske postopke z vlažno toploto (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 à la chaleur humide (ISO 11138-3:2006)Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:prEN ISO 11138-3kSIST prEN ISO 11138-3:2009en01-marec-2009kSIST prEN ISO 11138-3:2009SLOVENSKI
STANDARD
kSIST prEN ISO 11138-3:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 11138-3December 2008ICS 11.080.01Will supersede EN ISO 11138-3:2006
English VersionSterilization of health care products - Biological indicators - Part3: Biological indicators for moist heat sterilization processes(ISO 11138-3:2006)Stérilisation des produits de santé - Indicateurs biologiques- Partie 3: Indicateurs biologiques pour la stérilisation à lachaleur humide (ISO 11138-3:2006)Sterilisation von Produkten für die Gesundheitsfürsorge -Biologische Indikatoren - Teil 3: Biologische Indikatoren fürSterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2006)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 102.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11138-3:2008: EkSIST prEN ISO 11138-3:2009
prEN ISO 11138-3:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 11138-3:2009
prEN ISO 11138-3:2008 (E) 3 Foreword The text of ISO 11138-3:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 11138-3:2008 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11138-3:2006. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 11138-3:2006 has been approved by CEN as a prEN ISO 11138-3:2008 without any modification. kSIST prEN ISO 11138-3:2009
prEN ISO 11138-3:2008 (E) 4 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 a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. 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 clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA – Correspondence between
this European Standard and Directive 93/42/EEC on medical devices
WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard."
Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4 5, 13 The requirements of ISO 11138-1 apply 5.1 7.2, 7.3
7 7.3
9 10.1
kSIST prEN ISO 11138-3:2009
Reference numberISO 11138-3:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO11138-3Second edition2006-07-01Sterilization 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 kSIST prEN ISO 11138-3:2009
ISO 11138-3:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2006 – All rights reserved
kSIST prEN ISO 11138-3:2009
ISO 11138-3:2006(E) © ISO 2006 – All rights reserved iiiForeword 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 kSIST prEN ISO 11138-3:2009
ISO 11138-3:2006(E) iv © ISO 2006 – All rights reserved 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.
kSIST prEN ISO 11138-3:2009
INTERNATIONAL STANDARD ISO 11138-3:2006(E) © ISO 2006 – All rights reserved 1Sterilization of health
...
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