EN ISO 11138-1:2017
(Main)Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
ISO 11138-1:2017 specifies 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 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11138-1:2017)
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.
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.
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 Reinigungs-Desinfektionsgeräten oder dem Durchspülen und Bedampfen von Leitungen. Dieser Teil der ISO 11138 kann jedoch Elemente enthalten, die für solche mikrobiologischen Prüfsysteme von Bedeutung sind.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences générales (ISO 11138-1:2017)
ISO 11138-1:2017 spécifie 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.
ISO 11138-1:2017 spécifie les exigences fondamentales et communes applicables à toutes les parties pertinentes de l'ISO 11138. Les exigences relatives aux indicateurs biologiques pour des procédés particuliers spécifiés sont précisées dans les parties pertinentes de l'ISO 11138. En l'absence d'autre partie spécifique, le présent document s'applique.
NOTE Les réglementations nationales ou régionales sont susceptibles de s'appliquer.
ISO 11138-1:2017 ne s'applique pas aux systèmes d'essais microbiologiques utilisés dans les procédés fondés sur une extraction physique de micro-organismes, par exemple les procédés de filtration ou les procédés combinant une extraction physique et/ou mécanique et une inactivation microbiologique, par exemple l'utilisation de laveurs-désinfecteurs ou l'injection d'eau et de vapeur dans les conduites. Le présent document peut, toutefois, comporter des éléments applicables à ce type de systèmes d'essai microbiologiques.
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne zahteve (ISO 11138-1:2017)
Ta dokument določa splošne zahteve za proizvodnjo, označevanje, preskusne metode in lastnosti zmogljivosti bioloških indikatorjev, vključno z vcepljenimi prenašalci in suspenzijami, ter njihovih komponent, ki se uporabljajo pri potrjevanju in rutinskem spremljanju sterilizacijskih postopkov.
Ta dokument določa osnovne in splošne zahteve, ki se uporabljajo za vse dele standarda ISO 11138.
Zahteve za biološke indikatorje za posebej določene postopke so podane v ustreznih delih standarda ISO 11138. Če ni podan noben specifičen nadaljnji del, se uporablja ta dokument.
OPOMBA: mogoče je uporabiti nacionalne ali regionalne predpise.
Ta dokument se ne uporablja za mikrobiološke preskusne sisteme v postopkih, ki temeljijo na fizičnem odstranjevanju mikroorganizmov, npr. filtrirne postopke ali postopke, ki združujejo fizično in/ali mehansko odstranjevanje z mikrobiološko inaktivacijo, kot je uporaba čistilno-dezinfekcijskih naprav ali spiranje in parna obdelava cevovodov. Vendar lahko ta dokument vsebuje elemente, ki ustrezajo takim mikrobiološkim preskusnim sistemom.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-1:2006
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne
zahteve (ISO 11138-1:2017)
Sterilization of health care products - Biological indicators - Part 1: General requirements
(ISO 11138-1:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil1:
Allgemeine Anforderungen (ISO 11138-1:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences
générales (ISO 11138-1:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-1:2017
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.
EN ISO 11138-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-1:2006
English Version
Sterilization of health care products - Biological indicators
- Part 1: General requirements (ISO 11138-1:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 1: Exigences générales (ISO 11138- Gesundheitsfürsorge - Biologische Indikatoren - Teil 1:
1:2017) Allgemeine Anforderungen (ISO 11138-1:2017)
This European Standard was approved by CEN on 19 January 2017.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11138-1:2017) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices”, 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 September 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
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 11138-1:2006.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-1:2006:
— Normative references and bibliography updated;
— Terms and definitions „F -value“ und „packaging system“ deleted;
BIO
— General manufacturing requirements (clause 4) including Table 1 revised, e.g. requirements on
traceability added;
— requirements on carrier and the primary and secondary packaging revised;
— general resistance requirements (6.1.2 and 6.4.3) revised;
— requirements on software validation (7.4) and detection systems (7.5) added;
— for determination of growth inhibition by carriers and primary packaging materials exposed to
sterilization processes the number of probes was increased and requirements revised (see Annex
B).
EN 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
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11138-1:2017 has been approved by CEN as EN ISO 11138-1:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 11138-1
Third edition
2017-03
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 11138-1:2017(E)
©
ISO 2017
ISO 11138-1:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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ii © ISO 2017 – All rights reserved
ISO 11138-1:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General manufacturing requirements . 4
4.1 Manufacturing controls . 4
4.1.1 Quality management systems . 4
4.1.2 Traceability . 4
4.1.3 Finished product requirements . 4
4.1.4 Personnel . 4
4.2 Test organism . 4
4.2.1 Strain . 4
4.2.2 Originating inoculum for suspension. 5
4.2.3 Test organism count . 5
4.3 Information to be provided by the manufacturer (labelling) . 5
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 . 7
5.4 Biological indicators . 8
5.5 Self-contained biological indicators . 8
6 Determination of population and resistance . 8
6.1 General resistance requirements . 8
6.2 Test organism . 8
6.3 Population of test organisms . 8
6.4 Resistance characteristics . 9
6.5 Test conditions . 9
7 Culture conditions.10
7.1 Incubator .10
7.2 Growth medium .10
7.3 Incubation .10
7.4 Software validation .11
7.5 Incubation time using detection system .11
Annex A (normative) Determination of viable count .12
Annex B (normative) Determination of growth inhibition by carriers and primary
packaging materials exposed to sterilization processes .14
Annex C (normative) D value determination by survivor curve method .17
Annex D (normative) D value determination by fraction negative meth
...
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