EN ISO 14161:2009

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
ISO 14161:2009 applies to biological indicators for which International Standards exist.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 14161:2009)

Diese Internationale Norm enthält einen Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen, die durch die Anwendung von biologischen Indikatoren bei der Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren erzielt werden. Diese Internationale Norm gilt für biologische Indikatoren, für die Internationale Normen vorliegen.
ANMERKUNG 1   Siehe z. B. Normen der Reihe ISO 11138.
ANMERKUNG 2   Die allgemeinen Informationen dieser Internationalen Norm können auch nutzbringend auf Verfahren und biologische Indikatoren anwendbar sein, für die zurzeit keine Internationalen Normen zur Verfügung stehen, wie z. B. neue und in Entwicklung befindliche Sterilisationsverfahren.
Diese Internationale Norm umfasst keine Verfahren, die ausschließlich auf physikalischer Entfernung von Mikroorganismen, z. B. durch Filtration, beruhen.
Diese Internationale Norm gilt nicht für Kombinationsverfahren, die z. B. Reinigungs /Desinfektionsgeräte verwenden oder das Durchspülen und die Dampfbehandlung von Rohrleitungen.
Diese Internationale Norm gilt nicht für Sterilisationsverfahren mit Flüssigkeiten.

Stérilisation des produits de santé - Indicateurs biologiques - Directives générales pour la sélection, l'utilisation et l'interprétation des résultats (ISO 14161:2009)

L'ISO 14161:2009 fournit des directives pour la sélection, l'utilisation et l'interprétation des résultats issus de l'application des indicateurs biologiques dans le développement, la validation et le contrôle périodique des procédés de stérilisation.
L'ISO 14161:2009 s'applique aux indicateurs biologiques pour lesquels il existe des Normes internationales.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - Navodilo za izbiro, uporabo in predstavitev rezultatov (ISO 14161:2009)

Ta mednarodni standard zagotavlja navodilo za izbiro, uporabo in predstavitev rezultatov delovanja bioloških indikatorjev, kadar se uporabljajo pri razvoju, validaciji in rutinskem spremljanju sterilizacijskih postopkov. Ta mednarodni standard velja za biološke indikatorje, za katere obstajajo mednarodni standardi.

General Information

• Status: Withdrawn
• Publication Date: 14-Sep-2009
• Withdrawal Date: 16-Apr-2019
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 7 - Biological and chemical indicators
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 17-Apr-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 14161:2010 - Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

Relations

• Replaces: EN ISO 14161:2000 - Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000)
• Effective Date: 19-Sep-2009
• Replaced By: EN ISO 11138-7:2019 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
• Effective Date: 24-Apr-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 14161:2001
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - Navodilo za izbiro,
uporabo in predstavitev rezultatov (ISO 14161:2009)
Sterilization of health care products - Biological indicators - Guidance for the selection,
use and interpretation of results (ISO 14161:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren -
Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO
14161:2009)
Stérilisation des produits de santé - Indicateurs biologiques - Directives générales pour la
sélection, l'utilisation et l'interprétation des résultats (ISO 14161:2009)
Ta slovenski standard je istoveten z: EN ISO 14161:2009
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 14161
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2009
ICS 11.080.01 Supersedes EN ISO 14161:2000
English Version
Sterilization of health care products - Biological indicators -
Guidance for the selection, use and interpretation of results (ISO
14161:2009)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Directives générales pour la sélection, l'utilisation et Biologische Indikatoren - Leitfaden für die Auswahl,
l'interprétation des résultats (ISO 14161:2009) Verwendung und Interpretation von Ergebnissen (ISO
14161:2009)
This European Standard was approved by CEN on 31 July 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 14161:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 14161:2009) 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 March 2010, 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 14161:2000.
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 14161:2009 has been approved by CEN as a EN ISO 14161:2009 without any modification.

INTERNATIONAL ISO
STANDARD 14161
Second edition
2009-09-15
Sterilization of health care products —
Biological indicators — Guidance for the
selection, use and interpretation of
results
Stérilisation des produits de santé — Indicateurs biologiques —
Directives générales pour la sélection, l'utilisation et l'interprétation des
résultats
Reference number
ISO 14161:2009(E)
©
ISO 2009
ISO 14161:2009(E)
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ISO 14161:2009(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General .5
5 Characteristics of biological indicators .7
5.1 General .7
5.2 Test organism suspension for direct inoculation of products.7
5.3 Inoculated carriers .8
5.4 Self-contained biological indicators.8
5.5 Other biological indicators.9
6 Selection of supplier .9
6.1 General .9
6.2 Documentation .10
7 Biological indicators in process development.11
7.1 General .11
7.2 Overkill approach .12
7.3 Combined biological indicator and bioburden method.12
7.4 Bioburden method.13
8 Biological indicators in sterilization validation.14
8.1 General .14
8.2 Placement and handling of biological indicators .14
8.3 Sterilizer qualification .14
8.4 Performance qualification .14
8.5 Review and approval of validation .15
8.6 Requalification.15
9 Biological indicators in routine monitoring.15
9.1 General .15
9.2 Placement and handling of biological indicators .15
9.3 Process challenge device (PCD).16
10 Results.16
10.1 General .16
10.2 Interpretation of results .16
11 Application of biological indicator standards .17
11.1 General assessment of biological indicator performance by the user.17
11.2 Nominal population of test organism.17
11.3 Resistance determination.18
11.4 z value determination .20
11.5 F equivalent sterilization value determination .22
(T, z)
11.6 Establishing spore-log-reduction (SLR) .23
11.7 Sterility assurance level (SAL) calculation.23
11.8 Test equipment .24
12 Culture conditions.24
12.1 General .24
12.2 Incubation temperature.24
ISO 14161:2009(E)
12.3 Incubation period.25
12.4 Choice of growth medium.25
13 Third-party requirements .26
13.1 General.26
13.2 Minimum requirements for replicates and total number of biological indicators .26
13.3 Test equipment .
...