EN ISO 11737-1:2018
(Main)Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2018)
Dieses Dokument legt Anforderungen für die Zählung und mikrobielle Charakterisierung der Population lebensfähiger Mikroorganismen auf oder in Produkten für die Gesundheitsfürsorge, Bauteile, Rohstoffen oder Verpackung fest und liefert dazu eine Anleitung.
ANMERKUNG 1 Art und Umfang der mikrobiellen Charakterisierung hängen von der vorgesehenen Verwendung der Daten über die Keimbelastung ab.
ANMERKUNG 2 Siehe Anhang A für einen Leitfaden zu den Abschnitten 1 bis 9.
Dieses Dokument gilt nicht für die Zählung oder Identifizierung kontaminierender Viren, Prionen oder Protozoen fest. Dies beinhaltet die Entnahme und das Erkennen der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und die Creutzfeldt Jakob Krankheit.
ANMERKUNG 3 Eine Anleitung zur Inaktivierung von Viren und Prionen kann in ISO 22442 3, ICH Q5A(R1) und ISO 13022 gefunden werden.
Dieses Dokument gilt nicht für die mikrobiologische Überwachung der Umgebung, in der die Produkte für die Gesundheitsfürsorge hergestellt werden.
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1: Détermination d'une population de micro-organismes sur des produits (ISO 11737-1:2018)
ISO 11737-1:2018 spécifie les exigences et fournit des recommandations relatives au dénombrement et à la caractérisation microbienne de la population de microorganismes viables sur ou dans un produit de santé, un composant, une matière première ou un emballage.
NOTE 1 La nature et l'étendue de la caractérisation microbienne dépendent de l'utilisation prévue des données de biocharge.
NOTE 2 Voir les recommandations relatives aux Articles 1 à 9 dans l'Annexe A.
ISO 11737-1:2018 ne s'applique pas au dénombrement ni à l'identification des virus, prions ou protozoaires. Cette exclusion englobe l'élimination et la détection des agents responsables des encéphalopathies spongiformes, telles que la tremblante du mouton, l'encéphalopathie spongiforme bovine ou la maladie de Creutzfeldt-Jakob.
NOTE 3 L'ISO 22442‑3, l'ICH Q5A(R1) et l'ISO 13022 contiennent des recommandations relatives à l'inactivation des virus et des prions.
ISO 11737-1:2018 ne s'applique pas à la surveillance microbiologique de l'environnement dans lequel sont fabriqués les produits de santé.
Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 1. del: Določevanje populacije mikroorganizmov na izdelku (ISO 11737-1:2018)
Ta dokument določa zahteve in podaja smernice za ugotavljanje števila in mikrobni karakterizaciji populacije živih mikroorganizmov na ali v izdelku, komponenti, surovini ali embalaži za zdravstveno nego
OPOMBA 1: Narava in obseg mikrobne karakterizacije sta odvisna od namenske uporabe podatkov o biološki obremenitvi.
OPOMBA 2: Za navodila o točkah od 1 do 9 glej dodatek A.
Ta dokument se ne uporablja pri ugotavljanju števila ali prepoznavanju virusnih, prionskih ali protozojskih kontaminantov. To vključuje odstranjevanje in zaznavanje vzročnih agentov spongiformnih encefalopatij, kot so praskavec, bovina spongiformna encefalopatija in Creutzfeldt-Jakobova bolezen.
OPOMBA 3: Smernice za inaktivacijo virusov in prionov so podane v standardih ISO 22442-3, ICH Q5A(R1) in ISO 13022.
Ta dokument se ne uporablja pri mikrobiološkem nadzoru okolja, v katerem se proizvajajo izdelki za zdravstveno nego.
General Information
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2018
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SIST EN ISO 11737-1:2006
SIST EN ISO 11737-1:2006/AC:2009
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Sterilization of health care products - Microbiological methods - Part 1: Determination of
a population of microorganisms on products (ISO 11737-1:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren -
Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-
1:2018)
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1: Détermination
d'une population de micro-organismes sur des produits (ISO 11737-1:2018)
Ta slovenski standard je istoveten z: EN ISO 11737-1:2018
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
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 11737-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2018
EUROPÄISCHE NORM
ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-1:2006
English Version
Sterilization of health care products - Microbiological
methods - Part 1: Determination of a population of
microorganisms on products (ISO 11737-1:2018)
Stérilisation des produits de santé - Méthodes Sterilisation von Produkten für die
microbiologiques - Partie 1: Détermination d'une Gesundheitsfürsorge - Mikrobiologische Verfahren -
population de micro-organismes sur des produits (ISO Teil 1: Bestimmung der Population von
11737-1:2018) Mikroorganismen auf Produkten (ISO 11737-1:2018)
This European Standard was approved by CEN on 6 December 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11737-1:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . Error! Bookmark not defined.
European foreword
This document (EN ISO 11737-1:2018) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
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 July 2018, and conflicting national standards shall be
withdrawn at the latest by July 2018.
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.
This document supersedes EN ISO 11737-1:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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 11737-1:2018 has been approved by CEN as EN ISO 11737-1:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 11737-1
Third edition
2018-01
Sterilization of health care products —
Microbiological methods —
Part 1:
Determination of a population of
microorganisms on products
Stérilisation des produits de santé — Méthodes microbiologiques —
Partie 1: Détermination d'une population de microorganismes sur des
produits
Reference number
ISO 11737-1:2018(E)
©
ISO 2018
ISO 11737-1:2018(E)
© ISO 2018
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ii © ISO 2018 – All rights reserved
ISO 11737-1:2018(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 Documentation . 4
4.2 Management r esponsibility . 5
4.3 Product realization . 5
4.4 Measurement, analysis and improvement . 5
5 Selection of products . 5
5.1 General . 5
5.2 Sample item portion (SIP) . 6
6 Methods of determination and microbial characterization of bioburden .6
6.1 Determination of bioburden . 6
6.1.1 Selection of an appropriate method . 6
6.1.2 Neutralization of inhibitory substances . 7
6.1.3 Removal of microorganisms . 7
6.1.4 Culturing of microorganisms . 7
6.1.5 Enumeration of microorganisms . 7
6.2 Microbial characterization of bioburden . 7
7 Validation of the method for determining bioburden . 8
7.1 General . 8
7.2 Validation . 8
8 Routine determination of bioburden and interpretation of data . 8
8.1 General . 8
8.2 Limits of detection and plate counting . 8
8.3 Microbial characterization . 8
8.4 Bioburden data for extent of treatment . 9
8.5 Bioburden spikes . 9
8.6 Bioburden levels . 9
8.7 Data analysis . 9
8.8 Statistical methods . 9
9 Maintenance of the method for determining bioburden . 9
9.1 Changes to the product and/or manufacturing process . 9
9.2 Changes to the method for determining bioburden . 9
9.3 Requalification of the method for determining bioburden . 9
Annex A (informative) Guidance on the determination of a population of microorganisms
on products .10
Annex B (informative) Guidance on methods to determine bioburden .27
Annex C (informative) Validation of bioburden recovery efficiency .37
Annex D (informative) Typical assignment of responsibilities .45
Bibliography .47
ISO 11737-1:2018(E)
Foreword
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