SIST 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)
This document 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.
This document 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.
This document 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)
Dieser Teil von ISO 11737 legt Anforderungen für die Zählung und mikrobiologische Charakterisierung der Population lebensfähiger Mikroorganismen auf oder in Produkten für die Gesundheitsfürsorge, Bauteile, Rohstoffen oder Verpackung fest und liefert dazu Anleitungen.
ANMERKUNG 1 Art und Umfang der mikrobiologischen Charakterisierung hängen von der vorgesehenen Verwendung der Daten über die Keimbelastung ab.
Dieser Teil von ISO 11737 legt keine Anforderungen für die Zählung oder Identifizierung kontaminierender Viren, Prionen oder Protozoen fest. Dies beinhaltet die Entfernung und das Erkennen der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und die Creutzfeldt-Jakob-Krankheit. Eine Anleitung zur Inaktivierung von Viren und Prionen kann in ISO 22442-3, ICH Q5A(R1) und ISO 13022 gefunden werden.
Dieser Teil von ISO 11737 legt keine Anforderungen fest oder gibt Anleitungen an 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
SIST EN ISO 11737-1:2018
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
SIST EN ISO 11737-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11737-1:2018
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SIST EN ISO 11737-1:2018
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.
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SIST EN ISO 11737-1:2018
EN ISO 11737-1:2018 (E)
Contents Page
European foreword . Error! Bookmark not defined.
2
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SIST EN ISO 11737-1:2018
EN ISO 11737-1:2018 (E)
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.
3
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SIST EN ISO 11737-1:2018
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SIST EN ISO 11737-1:2018
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
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
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ISO copyright office
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Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11737-1:2018
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 2018 – All rights reserved iii
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This third edition cancels and replaces the second edition (ISO 11737-1:2006), which has been
technically revised. It also incorporates the Technical Corrigendum ISO 11737-1:2006/Cor.1:2007.
The main changes compared to the previous edition are as follows:
— the term “bioburden spikes” has been introduced as a normal and consistent part of the bioburden,
and examples of data have been provided;
— clarification has been added that package testing is not typically done except when it is an integral
part of the product;
— more information has been provided on the most probable number (MPN) technique and its
applications;
— details have been provided on ways to improve limit of detection (LOD) and correct use of the data;
— some discussion has been deleted of statistical methods for the evaluation of bioburden data where
information was not typical or not required;
— a table has been added with criteria for selection of a bioburden recovery efficiency approach, the
use of the correction factor (CF) has been explained, and the bioburden recovery efficiency value
of < 50 % mentioned for technique modifications has been eliminated;
— more information has been provided on the application and performance of a bioburden method
suitability test;
— a section has been added to detail rules for direct plate counts, estimated counts and counts beyond
the ideal range;
— a table has been added to clarify where typical responsibilities reside for the manufacturer or the
laboratory;
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
— the focus on a risk-based approach has been increased, including the purpose for which bioburden
data will be used.
A list of all parts in the ISO 11737 series can be found on the ISO website.
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
Introduction
A sterile health care product is one that is free of viable microorganisms. International Standards that
specify requirements for the validation and routine control of sterilization processes require, when it
is necessary to supply a sterile health care product, that adventitious microbiological contamination of
a health care product prior to sterilization be minimized. Such products are non-sterile. The purpose
of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile
products into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents
used to sterilize health care products can generally best be described by an exponential relationship
between the numbers of microorganisms surviving and the extent of treatment with the sterilizing
agent. Inevitably, this means there is always a finite probability that a microorganism can survive
regardless of the extent of treatment applied. For a given treatment, the probability of survival is
determined by the number and resistance of microorganisms and by the environment in which the
microorganisms exist during treatment. It follows that the sterility of any one product in a population
subjected to sterilization processing cannot be guaranteed and the sterility of a processed population
is defined in terms of the probability of there being a viable microorganism present on a product item.
Generic requirements of the quality management system for design and development, production,
installation and servicing are given in ISO 9001 and particular requirements for quality management
systems for medical device production are given in ISO 13485. The standards for quality management
systems recognize that, for certain processes used in manufacturing, the effectiveness of the process
cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example
of such a process. For this reason, sterilization processes are validated for use, the performance of the
sterilization process is monitored routinely and the equipment is maintained.
International Standards specifying procedures for the validation and routine control of the processes
used for the sterilization of health care products have been prepared (see, for example, ISO 14937,
ISO 11135, the ISO 11137 series, the ISO 17665 series and ISO 14160). However, it is important to
be aware that exposure to a properly validated and accurately controlled sterilization process is
not the only factor associated with the provision of assurance that the product is sterile and, in this
respect, suitable for its intended use. Furthermore, for the effective validation and routine control of
a sterilization process, it is important to be aware of the microbiological challenge that is presented in
the process, in terms of number, characteristics and properties of microorganisms.
The term “bioburden” is used to describe the population of viable microorganisms present on or in a
product and/or a sterile barrier system. A knowledge of bioburden can be used in a number of situations
as part of the following:
— validation and requalification of sterilization processes;
— routine monitoring for control of manufacturing processes;
— monitoring of raw materials, components or packaging;
— assessment of the efficiency of cleaning processes;
— an overall environmental monitoring programme.
Bioburden is the sum of the microbial contributions from a number of sources, including raw
materials, manufacturing of components, assembly processes, manufacturing environment,
assembly/manufacturing aids (e.g. compressed gases, water, lubricants), cleaning processes and
packaging of finished products. To control bioburden, attention should be given to the microbiological
status of these sources.
It is not possible to enumerate bioburden exactly and, in practice, a determination of bioburden is made
using a defined method. Definition of a single method for use in determining bioburden in all situations
is not practicable because of the wide variety of designs and materials of construction of health care
products. Nor is it possible to define a single technique to be used in all situations for the removal of
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
microorganisms in preparation for enumeration. Furthermore, the selection of culture conditions for
enumeration of microorganisms will be influenced by the types of microorganism likely to be present
on or in health care products.
This document specifies the requirements to be met for the determination of bioburden. In addition,
it gives guidance in the annexes to provide explanations and methods that are deemed suitable to
conform with the requirements. Methods other than those given in the guidance may be used, if they
are effective in achieving conformity with the requirements of this document.
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SIST EN ISO 11737-1:2018
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SIST EN ISO 11737-1:2018
INTERNATIONAL STANDARD ISO 11737-1:2018(E)
Sterilization of health care products — Microbiological
methods —
Part 1:
Determination of a population of microorganisms on
products
1 Scope
This document 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.
This document 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.
This document does not apply to the microbiological monitoring of the environment in which health
care products are manufactured.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10012, Measurement management systems — Requirements for measurement processes and measuring
equipment
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 15189, Medical laboratories — Requirements for quality and competence
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
3.1
batch
defined quantity of a product (3.16) intended or purported to be uniform in character and quality, which
has been produced during a defined cycle of manufacture
1)
[SOURCE: ISO 11139:— , 3.21]
3.2
bioburden
population of viable microorganisms on or in a product (3.16) and/or sterile barrier system (3.22)
[SOURCE: ISO 11139:—, 3.23]
3.3
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms
from a product (3.16) and/or failure to culture microorganisms
[SOURCE: ISO 11139:—, 3.24]
3.4
bioburden estimate
value established (3.10) by applying a bioburden correction factor (3.3) to a bioburden (3.2) count
[SOURCE: ISO 11139:—, 3.25]
3.5
bioburden method suitability
assessment of the test method to demonstrate its ability to allow microbial growth
[SOURCE: ISO 11139:—, 3.168, modified — “bioburden” has been added to the term.]
3.6
bioburden spike
individual bioburden (3.2) value that is significantly greater than other bioburden values in a set
[SOURCE: ISO 11139:—, 3.26]
3.7
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in conjunction with a corrective action (3.8).
[SOURCE: ISO 9000:2015, 3.12.3, modified — The Note 1 to entry has been revised and the Note 2 to
entry has been deleted.]
3.8
corrective action
situation action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.15) is taken to
prevent occurrence.
Note 3 to entry: There is a distinction between correction (3.7) and corrective action.
[SOURCE: ISO 9000:2015, 3.12.2, modified — “situation” has been added to the definition and the Note 3
to entry has been replaced.]
1) Under preparation. Stage at the time of publication: ISO/DIS 11139:2017.
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SIST EN ISO 11737-1:2018
ISO 11737-1:2018(E)
3.9
culture condition
combination of growth media and manner of incubation used to promote germination, growth, and/or
multiplication of microorganisms
Note 1 to entry: The manner of incubation can include the temperature, time, and any other conditions specified
for incubation.
[SOURCE: ISO 11139:—, 3.71]
3.10
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO 11139:—, 3.107]
3.11
facultative microorganism
microorganism capable of both aerobic and anaerobic metabolism
[SOURCE: ISO 11139:—, 3.114]
3.12
health care product
medical device, including in vitro diagnostic medical device, or medicinal product (3.16), including
biopharmaceutical
[SOURCE: ISO 11139:—, 3.132]
3.13
microbial characterization
process by which microorganisms are grouped into categories
Note 1 to entry: Categories can be broadly based, for example, on the use of selective media, colony or cellular
morphology, staining properties or other characteristics.
[SOURCE: ISO 11139:—, 3.170]
3.14
obligate anaerobe
organism that lives and grows in the absence of molecular oxygen
[SOURCE: ISO 11139:—, 3.186]
3.15
preventive action
action to eliminate the cause of a potential nonconformity or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action (3.8) is taken to
prevent recurrence.
[SOURCE: ISO 9000:2015, 3.12.1]
3.16
pr
...
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