Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)

This document specifies general requirements for production, labelling, test methods and performance
characteristics of biological indicators, including inoculated carriers and suspensions, and their
components, to be used in the validation and routine monitoring of sterilization processes.
This document specifies basic and common requirements that are applicable to all parts of ISO 11138.
Requirements for biological indicators for particular specified processes are provided in the relevant
parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
This document does not apply to microbiological test systems for processes that rely on physical removal
of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical
removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming
of pipelines. This document, however, can contain elements relevant to such microbiological test
systems.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil1: Allgemeine Anforderungen (ISO 11138-1:2017)

Dieser Teil von ISO 11138 enthält allgemeine Anforderungen an die Herstellung, Kennzeichnung, Prüfverfahren und Leistungsmerkmale bei biologischen Indikatoren, einschließlich beimpfter Keimträger und Suspensionen und deren Bestandteilen, die bei der Validierung und Routineüberwachung von Sterilisations¬verfahren verwendet werden sollen.
Dieser Teil von ISO 11138 legt grundlegende und allgemeine Anforderungen fest, die für alle Folgeteile der ISO 11138 gelten. Anforderungen an biologische Indikatoren für besonders festgelegte Verfahren sind in den Folgeteilen der ISO 11138 enthalten. Wenn kein spezifischer Folgeteil erarbeitet wird, gilt dieser Teil.
ANMERKUNG   Nationale oder regionale Bestimmungen können gelten.
Dieser Teil der ISO 11138 gilt nicht für mikrobiologische Prüfsysteme für Verfahren, die auf der physikalischen Beseitigung von Mikroorganismen beruhen, z. B. Filtrationsverfahren oder Verfahren, bei denen die physikalische und/oder mechanische Keimentfernung mit einer mikrobiologischen Inaktivierung verbunden wird, wie bei der Anwendung von Reinigungs-Desinfektionsgeräten oder dem Durchspülen und Bedampfen von Leitungen. Dieser Teil der ISO 11138 kann jedoch Elemente enthalten, die für solche mikrobiologischen Prüfsysteme von Bedeutung sind.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences générales (ISO 11138-1:2017)

ISO 11138-1:2017 spécifie les exigences générales relatives à la production, à l'étiquetage, aux méthodes d'essai et fournit les caractéristiques de performance des indicateurs biologiques, notamment les porte-germes inoculés et les suspensions et leurs composants, à utiliser dans la validation et la surveillance de routine des procédés de stérilisation.
ISO 11138-1:2017 spécifie les exigences fondamentales et communes applicables à toutes les parties pertinentes de l'ISO 11138. Les exigences relatives aux indicateurs biologiques pour des procédés particuliers spécifiés sont précisées dans les parties pertinentes de l'ISO 11138. En l'absence d'autre partie spécifique, le présent document s'applique.
NOTE Les réglementations nationales ou régionales sont susceptibles de s'appliquer.
ISO 11138-1:2017 ne s'applique pas aux systèmes d'essais microbiologiques utilisés dans les procédés fondés sur une extraction physique de micro-organismes, par exemple les procédés de filtration ou les procédés combinant une extraction physique et/ou mécanique et une inactivation microbiologique, par exemple l'utilisation de laveurs-désinfecteurs ou l'injection d'eau et de vapeur dans les conduites. Le présent document peut, toutefois, comporter des éléments applicables à ce type de systèmes d'essai microbiologiques.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne zahteve (ISO 11138-1:2017)

Ta dokument določa splošne zahteve za proizvodnjo, označevanje, preskusne metode in lastnosti zmogljivosti bioloških indikatorjev, vključno z vcepljenimi prenašalci in suspenzijami, ter njihovih komponent, ki se uporabljajo pri potrjevanju in rutinskem spremljanju sterilizacijskih postopkov.
Ta dokument določa osnovne in splošne zahteve, ki se uporabljajo za vse dele standarda ISO 11138.
Zahteve za biološke indikatorje za posebej določene postopke so podane v ustreznih delih standarda ISO 11138. Če ni podan noben specifičen nadaljnji del, se uporablja ta dokument.
OPOMBA: mogoče je uporabiti nacionalne ali regionalne predpise.
Ta dokument se ne uporablja za mikrobiološke preskusne sisteme v postopkih, ki temeljijo na fizičnem odstranjevanju mikroorganizmov, npr. filtrirne postopke ali postopke, ki združujejo fizično in/ali mehansko odstranjevanje z mikrobiološko inaktivacijo, kot je uporaba čistilno-dezinfekcijskih naprav ali spiranje in parna obdelava cevovodov. Vendar lahko ta dokument vsebuje elemente, ki ustrezajo takim mikrobiološkim preskusnim sistemom.

General Information

Status
Published
Public Enquiry End Date
29-Nov-2015
Publication Date
18-May-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-Apr-2017
Due Date
30-Jun-2017
Completion Date
19-May-2017

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SLOVENSKI STANDARD
SIST EN ISO 11138-1:2017
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-1:2006

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne

zahteve (ISO 11138-1:2017)

Sterilization of health care products - Biological indicators - Part 1: General requirements

(ISO 11138-1:2017)

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil1:

Allgemeine Anforderungen (ISO 11138-1:2017)

Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences

générales (ISO 11138-1:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-1:2017
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-1:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-1:2017
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SIST EN ISO 11138-1:2017
EN ISO 11138-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-1:2006
English Version
Sterilization of health care products - Biological indicators
- Part 1: General requirements (ISO 11138-1:2017)

Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die

biologiques - Partie 1: Exigences générales (ISO 11138- Gesundheitsfürsorge - Biologische Indikatoren - Teil 1:

1:2017) Allgemeine Anforderungen (ISO 11138-1:2017)
This European Standard was approved by CEN on 19 January 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: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11138-1:2017
EN ISO 11138-1:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11138-1:2017
EN ISO 11138-1:2017 (E)
European foreword

This document (EN ISO 11138-1:2017) 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 September 2017 and conflicting national standards

shall be withdrawn at the latest by September 2017.

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 11138-1:2006.

The standard is a full technical revision of the previous version. The following amendments have been

made in comparison with EN ISO 11138-1:2006:
— Normative references and bibliography updated;
— Terms and definitions „F -value“ und „packaging system“ deleted;
BIO

— General manufacturing requirements (clause 4) including Table 1 revised, e.g. requirements on

traceability added;
— requirements on carrier and the primary and secondary packaging revised;
— general resistance requirements (6.1.2 and 6.4.3) revised;
— requirements on software validation (7.4) and detection systems (7.5) added;

— for determination of growth inhibition by carriers and primary packaging materials exposed to

sterilization processes the number of probes was increased and requirements revised (see Annex

B).

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

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,

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SIST EN ISO 11138-1:2017
EN ISO 11138-1:2017 (E)

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 11138-1:2017 has been approved by CEN as EN ISO 11138-1:2017 without any

modification.
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SIST EN ISO 11138-1:2017
INTERNATIONAL ISO
STANDARD 11138-1
Third edition
2017-03
Sterilization of health care products —
Biological indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 1: Exigences générales
Reference number
ISO 11138-1:2017(E)
ISO 2017
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General manufacturing requirements ........................................................................................................................................... 4

4.1 Manufacturing controls ................................................................................................................................................................... 4

4.1.1 Quality management systems ............................................................................................................................... 4

4.1.2 Traceability ........................................................................................................................................................................... 4

4.1.3 Finished product requirements .......................................................................................................................... 4

4.1.4 Personnel ................................................................................................................................................................................ 4

4.2 Test organism ........................................................................................................................................................................................... 4

4.2.1 Strain .......................................................................................................................................................................................... 4

4.2.2 Originating inoculum for suspension............................................................................................................. 5

4.2.3 Test organism count ...................................................................................................................................................... 5

4.3 Information to be provided by the manufacturer (labelling) ......................................................................... 5

4.4 Storage and transport ....................................................................................................................................................................... 6

5 Specific manufacturing requirements ........................................................................................................................................... 7

5.1 Suspensions ............................................................................................................................................................................................... 7

5.2 Carrier, primary and secondary packaging .................................................................................................................... 7

5.3 Inoculated carrier ................................................................................................................................................................................. 7

5.4 Biological indicators ........................................................................................................................................................................... 8

5.5 Self-contained biological indicators ..................................................................................................................................... 8

6 Determination of population and resistance .......................................................................................................................... 8

6.1 General resistance requirements ............................................................................................................................................ 8

6.2 Test organism ........................................................................................................................................................................................... 8

6.3 Population of test organisms ...................................................................................................................................................... 8

6.4 Resistance characteristics ............................................................................................................................................................. 9

6.5 Test conditions ........................................................................................................................................................................................ 9

7 Culture conditions............................................................................................................................................................................................10

7.1 Incubator ...................................................................................................................................................................................................10

7.2 Growth medium ..................................................................................................................................................................................10

7.3 Incubation ................................................................................................................................................................................................10

7.4 Software validation ..........................................................................................................................................................................11

7.5 Incubation time using detection system ........................................................................................................................11

Annex A (normative) Determination of viable count .......................................................................................................................12

Annex B (normative) Determination of growth inhibition by carriers and primary

packaging materials exposed to sterilization processes .........................................................................................14

Annex C (normative) D value determination by survivor curve method .....................................................................17

Annex D (normative) D value determination by fraction negative method ..............................................................21

Annex E (normative) Survival-kill response characteristics ....................................................................................................37

Annex F (informative) Relationship between components of biological indicators........................................39

Bibliography .............................................................................................................................................................................................................................40

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(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: w w w . i s o .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 11138-1:2006), which has been

technically revised.
A list of all parts of ISO 11138 can be found on the ISO website.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
Introduction

This document specifies general requirements for production, labelling, test methods and performance

requirements for the manufacture of biological indicators including inoculated carriers and suspensions

intended for use in validation and monitoring of sterilization processes. Other parts of ISO 11138

provide additional specific requirements for biological indicators for defined sterilization processes.

A graphic description of a biological indicator and its components is presented in Table F.1. The

presentation includes the two types of biological indicators which are covered by ISO 11138 (all parts).

This shows that inoculated carriers can be presented directly to the sterilizing agent without prior

packaging, or included in a primary package that permits access by the sterilizing agent.

The resistance characteristics depend on the type of test organism, its numbers, the method of

preparation, the substrate upon which it is inoculated, environmental conditions during inoculation

and drying and the effects of the primary package. Advice on selection, use and interpretation of results

of biological indicators can be found in ISO 14161.

For any individual sterilization process, including those covered in relevant parts of ISO 11138, the

resistance of the biological indicator will also depend on its microenvironment during testing. In

theory, this could lead to an infinite variation in the preparation of biological indicators. Moreover, a

sterilization process could be manipulated in infinite variety to suit each possible set of conditions to

which products could be exposed. It has, therefore, been a routine practice to manufacture biological

indicators that, when exposed to a set of conditions in a defined sterilization process, provide resistance

characteristics expressed as D values and, where relevant, z values. Such values are set out in the

relevant parts of ISO 11138.

The ISO 11138 series represents the current “state-of-the-art” according to the experts representing

manufacturers, users and regulatory authorities involved in developing this document.

Biological indicators for specific sterilization processes not covered by reference test conditions in

relevant parts of ISO 11138 should comply with the general requirements in this document, including

the resistance testing procedures. Such biological indicators might not be well enough described,

or might be used for novel sterilization processes, or might be represented by isolated bioburden

microorganisms. If microorganisms other than risk group 1 (WHO 2004) are included in these biological

indicators, appropriate safety measures (e.g. containment) are necessary.

Standards exist providing requirements for the validation and control of sterilization processes

(see Bibliography).

NOTE It is possible that some countries or regions have published other standards covering requirements

for sterilization or biological indicators (see Bibliography).
© ISO 2017 – All rights reserved v
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SIST EN ISO 11138-1:2017
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SIST EN ISO 11138-1:2017
INTERNATIONAL STANDARD ISO 11138-1:2017(E)
Sterilization of health care products — Biological
indicators —
Part 1:
General requirements
1 Scope

This document specifies general requirements for production, labelling, test methods and performance

characteristics of biological indicators, including inoculated carriers and suspensions, and their

components, to be used in the validation and routine monitoring of sterilization processes.

This document specifies basic and common requirements that are applicable to all parts of ISO 11138.

Requirements for biological indicators for particular specified processes are provided in the relevant

parts of ISO 11138. If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

This document does not apply to microbiological test systems for processes that rely on physical removal

of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical

removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming

of pipelines. This document, however, can contain elements relevant to such microbiological test

systems.
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 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of

a population of microorganisms on products

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment

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 https:// www .iso .org/ obp/
© ISO 2017 – All rights reserved 1
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
3.1
biological indicator

test system containing viable microorganisms providing a defined resistance to a specified

sterilization process
[SOURCE: ISO/TS 11139:2006, 2.3]
3.2
carrier
supporting material on or in which test microorganisms are deposited
3.3
colony forming unit
CFU

individual visible units of growth of microorganisms arising from a single cell or multiple cells

3.4
culture collection number

unique identification of the test organism allocated by a scientifically recognized service culture

collection
3.5
culture conditions

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/TS 11139:2006, 2.10]
3.6
D value
D value

time or dose required to achieve inactivation of 90 % of a population of the test microorganism under

stated conditions

Note 1 to entry: Other critical process variable(s) exhibiting first order inactivation kinetics can achieve an

inactivation of 90 % of a population of the test microorganism under stated conditions.

[SOURCE: ISO/TS 11139:2006, 2.11, modified]
3.7
inactivation
loss of ability of microorganisms to grow and/or multiply
[SOURCE: ISO/TS 11139:2006, 2.21]
3.8
inoculated carrier

supporting material on or in which a defined number of viable test organisms have been deposited

Note 1 to entry: See Annex F.
3.9
nominal population
manufacturer’s stated number of viable microorganisms
Note 1 to entry: This is generally expressed in log function (e.g. 10 ).
2 © ISO 2017 – All rights reserved
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
3.10
primary package
element of the packaging system which maintains the integrity of the product

Note 1 to entry: The packaging system protects the inoculated carrier from damage and contamination without

preventing penetration of the sterilizing agent.
3.11
process challenge device
PCD

item designed to constitute a defined resistance to a sterilization process and used to assess

performance of the process
[SOURCE: ISO/TS 11139:2006, 2.33]
3.12
resistometer

test equipment designed to create defined reference combinations of the physical and/or chemical

variables of a sterilization process
[SOURCE: ISO 18472:2006, 3.11, modified]
3.13
secondary package
container in which biological indicators are packed for transport and storage
3.14
self-contained biological indicator

biological indicator presented in such a way that the primary package, intended for incubation, contains

the incubation medium required for recovery of the test organism
3.15
survival-kill window

extent of exposure to a sterilization process under defined conditions where there is a transition from

all biological indicators showing growth to all biological indicators showing no growth

3.16
survivor curve

graphical representation of the inactivation of a population of microorganisms with increasing

exposure to a microbicidal agent under stated conditions
3.17
suspension
viable test organisms suspended in a fluid

Note 1 to entry: Suspension can be a biological indicator if ready to use in a sealed glass ampoule or may be an

intermediate component used to produce an inoculated carrier or biological indicator.

3.18
viable count
actual number of recoverable colony-forming units or other appropriate units
Note 1 to entry: See Annex A.
3.19
z value

change in exposure temperature of a thermal sterilization process, which corresponds to a tenfold

change in D value
Note 1 to entry: See ISO 11138-3 and ISO 11138-4.
© ISO 2017 – All rights reserved 3
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems

A formal quality system (e.g. ISO 13485, GMPs or other national or regional requirements) to cover all

operations required by this document shall be established, documented and maintained. In particular,

precautions at all stages of production to minimize contamination that would adversely affect the

performance of the biological indicator shall be taken.
4.1.2 Traceability
4.1.2.1 Traceability of manufacturing components shall be maintained.

4.1.2.2 Manufacturing components shall include all materials incorporated in, or coming into direct

contact with, the test organism suspension, the inoculated carrier and/or its primary package.

4.1.3 Finished product requirements
The finished product shall comply with the following requirements:
a) labelling (4.3);
b) manufacturing (Clause 5);
c) resistance characteristics (6.4);
d) storage and transport (4.4);
e) incubation (7.3).

NOTE 1 Advice on methods for the use of biological indicators is provided in ISO 14161.

NOTE 2 National and/or regional requirements might exist, for example, in the various national or regional

pharmacopoeias.
4.1.4 Personnel

The procedures and methods in this document shall be carried out by suitably trained and experienced

laboratory personnel (see e.g. ISO 13485).
4.2 Test organism
4.2.1 Strain

4.2.1.1 Test organisms shall be of a defined strain, available through a recognized culture collection,

and shall be identified by appropriate test methods. A statement of traceability shall be provided to the

purchaser upon request.
4.2.1.2 The test organism shall be a strain that is

a) suitable for handling without special containment facilities, does not need specific containment

procedures for handling and does not have specific transport or mailing requirements (e.g. Risk

Group 1, WHO 2004), and
4 © ISO 2017 – All rights reserved
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SIST EN ISO 11138-1:2017
ISO 11138-1:2017(E)
b) sufficiently
...

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