EN ISO 11138-8:2021
(Main)Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.
1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT.
1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 8: Methode zur Validierung einer reduzierten Inkubationszeit eines biologischen Indikators (ISO 11138-8:2021)
1.1 Dieses Dokument legt die Anforderungen an ein Prüfverfahren fest, das zur Bestimmung oder Bestätigung einer reduzierten Inkubationszeit (en: reduced incubation time, RIT) zu verwenden ist, die kürzer ist als die in ISO 11138 1:2017, 7.3.2, festgelegte 7 tägige Referenz-Inkubationszeit für biologische Indikatoren, welche zur Überwachung von Sterilisationsverfahren mit feuchter Hitze oder mit Ethylenoxid (EO) eingesetzt werden.
ANMERKUNG Für biologische Indikatoren, die für die EO-Sterilisation verwendet werden, gilt die angegebene reduzierte Inkubationszeit für jedes 100 % EO Verfahren oder für jedes Verfahren, das EO-Gemische nutzt, unabhängig von der Produktbelastung.
1.2 Dieses Dokument ist anzuwenden für Hersteller biologischer Indikatoren (en: biological indicators, BIs) sowie für Endbenutzer von BIs, die beabsichtigen, eine reduzierte Inkubationszeit zu bestimmen, zu validieren oder zu bestätigen, wenn dies von ihrem Qualitätsmanagmentsystem gefordert wird.
1.3 Dieses Dokument ist nicht anzuwenden für biologische Indikatoren, die zur Überwachung von Sterilisations¬verfahren mit trockener Hitze, der Niedertemperatur-Dampf-Formaldehyd-Sterilisation (en: low temperature steam formaldehyde, LTSF) oder Sterilisationsverfahren mit verdampftem Wasserstoffperoxid (en: vaporized hydrogen peroxide , VH2O2) eingesetzt werden.
ANMERKUNG Die in diesem Dokument beschriebene Methode zur Bestimmung einer reduzierten Inkubationszeit für biologische Indikatoren, die zur Überwachung von Sterilisationsverfahren mit feuchter Hitze oder EO eingesetzt werden, wird seit vielen Jahren weitverbreitet verwendet. Es liegen allerdings nur in begrenztem Umfang Erfahrungen in der Anwendung dieser Methode zur Bestimmung einer verkürzten Inkubationszeit für biologische Indikatoren vor, die zur Überwachung von Sterilisationsverfahren mit trockener Hitze, der Niedertemperatur-Dampf-Formaldehyd-Sterilisation oder Sterilisationsverfahren mit verdampftem Wasserstoffperoxid eingesetzt werden. Diese Sterilisationsverfahren werden daher nicht in diesem Dokument behandelt.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 8 : Méthode pour la validation d'un temps d'incubation réduit pour un indicateur biologique (ISO 11138-8:2021)
1.1 Le présent document spécifie les exigences relatives à une méthode d’essai à utiliser pour établir ou confirmer un temps d’incubation réduit (TIR) inférieur au temps d’incubation de référence de 7 jours spécifié en 7.3.2 de l’ISO 11138-1:2017 pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur humide ou à l’oxyde d’éthylène (OE).
NOTE Pour les indicateurs biologiques utilisés pour la stérilisation à l’OE, le TIR déclaré s’applique à tous les procédés avec 100 % d’OE ou à ceux qui utilisent des mélanges d’OE, indépendamment de la charge du produit.
1.2 Le présent document est applicable aux fabricants d’indicateurs biologiques (IB) et aux utilisateurs finaux d'indicateurs biologiques qui ont l'intention, si leur système qualité l'exige, d'établir, de valider ou de confirmer un TIR.
1.3 Le présent document ne s’applique pas aux indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur sèche, à la vapeur et au formaldéhyde à basse température (LTSF) ou au peroxyde d'hydrogène vaporisé (VH2O2).
NOTE La méthode décrite dans le présent document pour établir un TIR pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur humide ou à l’oxyde d’éthylène est largement utilisée depuis de nombreuses années. L’expérience est en revanche limitée concernant l’utilisation de cette méthode pour établir un TIR pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur sèche, à la vapeur et au formaldéhyde à basse température ou au peroxyde d'hydrogène vaporisé. Par conséquent, le présent document ne traite pas de ces procédés de stérilisation.
Sterilizacija izdelkov za zdravstveno oskrbo - Biološki indikatorji - 8. del: Metoda za validacijo skrajšanega časa inkubacije biološkega indikatorja (ISO 11138-8:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2021
Sterilizacija izdelkov za zdravstveno oskrbo - Biološki indikatorji - 8. del: Metoda
za validacijo skrajšanega časa inkubacije biološkega indikatorja (ISO 11138-
8:2021)
Sterilization of health care products - Biological indicators - Part 8: Method for validation
of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 8:
Methode zur Validierung einer reduzierten Inkubationszeit eines biologischen Indikators
(ISO 11138-8:2021)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 8: Méthode pour la
validation d'un temps d'incubation réduit pour un indicateur biologique (ISO 11138-
8:2021)
Ta slovenski standard je istoveten z: EN ISO 11138-8:2021
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 11138-8
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health care products - Biological indicators
- Part 8: Method for validation of a reduced incubation
time for a biological indicator (ISO 11138-8:2021)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 8: Méthode pour la validation d'un Gesundheitsfürsorge - Biologische Indikatoren - Teil 8:
temps d'incubation réduit pour un indicateur Methode zur Validierung einer reduzierten
biologique (ISO 11138-8:2021) Inkubationszeit eines biologischen Indikators (ISO
11138-8:2021)
This European Standard was approved by CEN on 24 June 2021.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-8:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11138-8:2021) 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 January 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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
─ Part 6: Biological indicators for hydrogen peroxide sterilization processes
─ Part 7: Guidance for the selection, use and interpretation of results
─ Part 8: Method for validation of a reduced incubation time for a biological indicator
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11138-8:2021 has been approved by CEN as EN ISO 11138-8:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 11138-8
First edition
2021-07
Sterilization of health care products —
Biological indicators —
Part 8:
Method for validation of a reduced
incubation time for a biological
indicator
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 8: Méthode pour la validation d'un temps d'incubation réduit
pour un indicateur biologique
Reference number
ISO 11138-8:2021(E)
©
ISO 2021
ISO 11138-8:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 11138-8:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
5 Selection and preparation of samples . 3
6 Exposure and culturing . 3
7 Determination of reduced incubation time . 4
Bibliography . 7
ISO 11138-8:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
A list of all parts in the ISO 11138 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO 11138-8:2021(E)
Introduction
A biological indicator incubation time is the minimum period of cultivation required before making a
final determination that a biological indicator is negative (shows no growth). The reference incubation
time for biological indicators for established sterilization processes such as moist heat and ethylene
oxide is 7 d (see ISO 11138-1:2017). In some instances where biological indicator results are needed as
part of the product release process, a 7-day incubation time might not be practical. This is especially
the case where biological indicators are used to monitor sterilization processes in hospitals or other
health care facilities such as dental or general practitioner offices.
The purpose of a reduced incubation time procedure is to demonstrate recovery of the surviving test
organisms within the specified reduced incubation time period. The reduced incubation time is a
function of the test method and conditions used to establish the incubation time and is independent of
the process parameters for the sterilization method used to deliver the lethality.
Biological indicators with an incubation time of less than 7 d (a Reduced Incubation Time, or RIT)
have been in use since the 1970s. The methodology to determine the RIT was originally created by the
biological indicator manufacturers. Later, the United States Food and Drug Administration published
guidance for manufacturers seeking regulatory clearance to market biological indicators to health
care facilities in the United States (see Reference [1]). This guidance contained a protocol for validating
an incubation time that was less than 7 d. This document was specific to regulations for commercial
practices in a single country and did not address requirements for RIT methodology outside of that
application. The purpose of this document is to describe an internationally agreed approach to the
validation of the reduced incubation time of a biological indicator.
INTERNATIONAL STANDARD ISO 11138-8:2021(E)
Sterilization of health care products — Biological
indicators —
Part 8:
Method for validation of a reduced incubation time for a
biological indicator
1 Scope
1.1 This document specifies the requirements for a test method to be utilized to establish or confirm
a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in
7.3.2 of ISO 11138-1:2017 for biological indicators used
...
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