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

Status
Published
Publication Date
30-Jan-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
31-Jan-2018
Completion Date
31-Jan-2018

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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.

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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.
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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

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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;
iv © ISO 2018 – All rights reserved
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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.
© ISO 2018 – All rights reserved v
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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

vi © ISO 2018 – All rights reserved
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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.
© ISO 2018 – All rights reserved vii
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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
© ISO 2018 – All rights reserved 1
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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
[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.
2 © ISO 2018 – All rights reserved
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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
...

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