EN ISO 11138-1:2006
(Main)Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11138-1:2006)
1.1 Allgemeines
1.1.1 Dieser Teil von ISO 11138 enthält allgemeine Anforderungen an die Herstellung, Kennzeichnung, Prüfverfahren und Leistungsmerkmale bei biologischen Indikatoren, einschließlich beimpfter Keimträger und Suspensionen und deren Bestandteilen, die bei der Validierung und Routineüberwachung von Sterilisations¬verfahren verwendet werden sollen.
1.1.2 Dieser Teil von ISO 11138 legt grundlegende und allgemeine Anforderungen fest, die für alle Folgeteile der ISO 11138 gelten. Anforderungen an biologische Indikatoren für besonders festgelegte Verfahren sind in den Folgeteilen der ISO 11138 enthalten. Wenn kein spezifischer Folgeteil erarbeitet wird, gilt dieser Teil.
ANMERKUNG Nationale oder regionale Bestimmungen können gelten.
1.2 Nicht erfasste Gebiete
Dieser Teil der ISO 11138 gilt nicht für mikrobiologische Prüfsysteme für Verfahren, die auf der physikalischen Beseitigung von Mikroorganismen beruhen, z. B. Filtrationsverfahren oder Verfahren, bei denen die physikalische und/oder mechanische Keimentfernung mit einer mikrobiologischen Inaktivierung verbunden wird, wie bei der Anwendung von Wasch-Desinfektionsgeräten oder dem Durchspülen und Bedampfen von Leitungen. Dieser Teil der ISO 11138 könnte jedoch Elemente enthalten, die für solche mikrobiologischen Prüfsysteme von Bedeutung sind.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences générales (ISO 11138-1:2006)
L'ISO 11138-1:2006 fournit les exigences générales relatives à la production, à l'étiquetage, aux méthodes d'essai et fournit les caractéristiques de performance des indicateurs biologiques, notamment les porte-germes inoculés et les suspensions et leurs composants, à utiliser dans la validation et la surveillance de routine des procédés de stérilisation.
L'ISO 11138-1:2006 spécifie les exigences fondamentales et communes applicables à toutes les autres parties de l'ISO 11138. Les exigences relatives aux indicateurs biologiques pour des procédés particuliers spécifiés sont précisées dans les autres parties de l'ISO 11138. En l'absence d'autre partie spécifique, la présente partie s'applique.
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne zahteve (ISO 11138-1:2006)
General Information
Relations
Standards Content (Sample)
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.
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 11138-1:2006: 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)
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
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.