prEN ISO 14160

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2018)

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

Sterilisation von Produkten für die Gesundheitsfürsorge - Flüssige chemische Sterilisiermittel für Medizinprodukte für den einmaligen Gebrauch, bei denen tierische Gewebe und deren Derivate verwendet werden - Anforderungen an die Charakterisierung, Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14160:2018)

Stérilisation des produits de santé - Agents stérilisants chimiques liquides pour dispositifs médicaux non réutilisables utilisant des tissus animaux et leurs dérivés - Exigences pour la caractérisation, le développement, la validation et le contrôle de routine d'un procédé de stérilisation de dispositifs médicaux (ISO 14160:2018)

Le présent document spécifie les exigences relatives à la caractérisation d'un agent stérilisant chimique liquide et au développement, à la validation, au contrôle et à la surveillance du procédé de stérilisation par agents stérilisants chimiques liquides de dispositifs médicaux non réutilisables, partiellement ou entièrement constitués de matières d'origine animale.
Le présent document traite de la maîtrise des risques de contamination par des bactéries et des champignons au cours de l'application d'un procédé de stérilisation par produit chimique liquide. Il est nécessaire d'évaluer les risques associés à d'autres microorganismes en utilisant d'autres méthodes (voir la NOTE 1).
Le présent document ne s'applique pas aux matières d'origine humaine.
Le présent document ne décrit pas les méthodes de validation de l'inactivation des virus et des agents à l'origine des encéphalopathies spongiformes transmissibles (EST) (voir la NOTE 2 et la NOTE 3).
Le présent document ne décrit pas les méthodes de validation de l'inactivation ou de l'élimination des protozoaires et des parasites.
Les exigences relatives à la validation et au contrôle de routine décrites dans le présent document ne s'appliquent qu'au procédé de stérilisation défini d'un dispositif médical, qui est réalisé après le procédé de fabrication, et ne prennent pas en compte la létalité d'autres moyens de réduction de la charge biologique (voir la NOTE 4).
Le présent document ne spécifie pas les essais établissant les effets sur l'aptitude à l'emploi du dispositif médical qu'un quelconque procédé de stérilisation choisi pourrait entraîner (voir la NOTE 5).
Le présent document ne traite pas du taux d'agents stérilisants résiduels dans les dispositifs médicaux (voir la NOTE 6).
Les recommandations pour la caractérisation d'un agent stérilisant chimique liquide et le développement, la validation, le contrôle et la surveillance du procédé de stérilisation par agents stérilisants chimiques liquides de dispositifs médicaux non réutilisables, partiellement ou entièrement constitués de matières d'origine animale sont spécifiées à l'Annexe A informative.
NOTE 1 La mise en application préalable des principes de management du risque associé aux dispositifs médicaux utilisant des tissus d'origine animale, telle que décrite dans l'ISO 22442-1, est importante. L'ISO 18362 donne des informations sur le contrôle des risques microbiologiques durant le procédé de produits de santé à base de cellules.
NOTE 2 Les agents stérilisants chimiques liquides employés habituellement pour stériliser les tissus d'origine animale dans les dispositifs médicaux pourraient s'avérer inefficaces pour l'inactivation des agents à l'origine des EST, telles que l'encéphalopathie spongiforme bovine (ESB) ou la tremblante du mouton. Une validation satisfaisante, selon les critères du présent document, ne constitue pas nécessairement une preuve de l'inactivation d'agents infectieux de ce type. La maîtrise des risques liés à l'origine, à la collecte et au traitement de la matière d'origine animale est décrite dans l'ISO 22442-2.
NOTE 3 La validation de l'inactivation, de l'élimination, ou de l'élimination et de l'inactivation des virus et agents EST est décrite dans l'ISO 22442-3.
NOTE 4 Les procédés de fabrication des dispositifs médicaux contenant des tissus d'origine animale comportent fréquemment une exposition à des agents chimiques qui peuvent réduire de manière significative la charge biologique du disposit

Sterilizacija medicinskih pripomočkov - Tekoča kemijska sredstva za sterilizacijo medicinskih pripomočkov za enkratno uporabo, ki uporabljajo živalska tkiva in njihove derivate - Zahteve za določitev lastnosti, razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO/DIS 14160:2018) Sterilizacija izdelkov za zdravstveno nego

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14160:2018
01-junij-2018

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PHGLFLQVNLKSULSRPRþNRY]DHQNUDWQRXSRUDERNLXSRUDEOMDMRåLYDOVNDWNLYDLQ

QMLKRYHGHULYDWH=DKWHYH]DGRORþLWHYODVWQRVWLUD]YRMYDOLGDFLMRLQUXWLQVNR

NRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNHSULSRPRþNH,62',6


Sterilization of health care products - Liquid chemical sterilizing agents for single-use

medical devices utilizing animal tissues and their derivatives - Requirements for

characterization, development, validation and routine control of a sterilization process for

medical devices (ISO/DIS 14160:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Flüssige chemische

Sterilisiermittel für Medizinprodukte für den einmaligen Gebrauch, bei denen tierische

Gewebe und deren Derivate verwendet werden - Anforderungen an die
Charakterisierung, Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 14160:2018)

Stérilisation des produits de santé - Agents stérilisants chimiques liquides pour dispositifs

médicaux non réutilisables utilisant des tissus animaux et leurs dérivés - Exigences pour

la caractérisation, le développement, la validation et le contrôle de routine d'un procédé

de stérilisation de dispositifs médicaux (ISO/DIS 14160:2018)
Ta slovenski standard je istoveten z: prEN ISO 14160
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
oSIST prEN ISO 14160:2018 en,fr,de

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

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oSIST prEN ISO 14160:2018
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oSIST prEN ISO 14160:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14160
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-04-26 2018-07-19
Sterilization of health care products — Liquid chemical
sterilizing agents for single-use medical devices utilizing
animal tissues and their derivatives — Requirements for
characterization, development, validation and routine
control of a sterilization process for medical devices

Stérilisation des produits de santé — Agents stérilisants chimiques liquides pour dispositifs médicaux

non réutilisables utilisant des tissus animaux et leurs dérivés — Exigences pour la caractérisation, le

développement, la validation et le contrôle de routine d'un procédé de stérilisation de dispositifs médicaux

ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14160:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(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
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Published in Switzerland
ii © ISO 2018 – All rights reserved
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oSIST prEN ISO 14160:2018
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Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Quality management system elements ......................................................................................................................................... 6

4.1 Documentation ....................................................................................................................................................................................... 6

4.2 Management responsibility ......................................................................................................................................................... 6

4.3 Product realization .............................................................................................................................................................................. 6

4.4 Measurement, analysis and improvement — Control of non-conforming products .................. 7

5 Sterilizing agent characterization ...................................................................................................................................................... 7

5.1 General ........................................................................................................................................................................................................... 7

5.2 Sterilizing agent ..................................................................................................................................................................................... 7

5.3 Microbicidal effectiveness ............................................................................................................................................................. 7

5.4 Effects on materials ......... .................................................................................................................................................................... 8

5.5 Safety and the environment ......................................................................................................................................................... 8

6 Process and equipment characterization ................................................................................................................................... 8

6.1 General ........................................................................................................................................................................................................... 8

6.2 Process characterization ................................................................................................................................................................ 8

6.3 Equipment characterization ........................................................................................................................................................ 9

7 Product definition ............................................................................................................................................................................................... 9

8 Process definition .............................................................................................................................................................................................10

8.1 Purpose .......................................................................................................................................................................................................10

8.2 Determination of the inactivation kinetics ..................................................................................................................10

8.3 Method for neutralization ..........................................................................................................................................................11

8.4 Safety quality and performance ............................................................................................................................................11

9 Validation ..................................................................................................................................................................................................................11

9.1 General ........................................................................................................................................................................................................11

9.2 Installation qualification .............................................................................................................................................................12

9.2.1 Equipment ..........................................................................................................................................................................12

9.2.2 Installation .........................................................................................................................................................................12

9.3 Operational qualification ............................................................................................................................................................12

9.4 Performance qualification ..........................................................................................................................................................12

9.4.1 General...................................................................................................................................................................................12

9.4.2 Microbiological performance qualification ............................................................................................13

9.4.3 Physical performance qualification ..............................................................................................................14

9.4.4 Aseptic processing qualification .....................................................................................................................14

9.5 Review and approval of validation .....................................................................................................................................14

10 Routine monitoring and control .......................................................................................................................................................15

11 Product release from sterilization ..................................................................................................................................................17

12 Maintaining process effectiveness ..................................................................................................................................................17

12.1 General ........................................................................................................................................................................................................17

12.2 Maintenance of equipment ........................................................................................................................................................17

12.3 Requalification .....................................................................................................................................................................................17

12.4 Assessment of change ....................................................................................................................................................................18

Annex A (informative) Guidance for the application of this International Standard .....................................19

Annex B (informative) Determination of lethal rate of the sterilization process ...............................................31

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Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3), process definition

(see Clause 8), and microbiological performance qualification (see 9.4.2) ........................................35

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 90/385/EEC on active implantable medical devices

[OJ L 189] aimed to be covered ...........................................................................................................................................................36

Bibliography .............................................................................................................................................................................................................................38

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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 14160:2011), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— aligned definitions with those used in other standards for development, validation and routine

control of sterilization processes and added new definitions;
— incorporated defined terms consistently throughout the document;
— updated cross-references;

— revised Informative Annex A to follow the order of the normative body of the standard;

— added clarification to Normative Annex B in regards to applying the overkill approach.

A list of all parts in the ISO 14160 series can be found on the ISO website.
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Introduction

A sterile medical device is one that is free of viable microorganisms. International standards, which

specify requirements for validation and routine control of sterilization processes, require, when it

is necessary to supply a sterile medical device, that adventitious microbiological contamination of a

medical device prior to sterilization be minimized. Even so, medical devices produced under standard

manufacturing conditions in accordance with the requirements for quality management systems (see,

for example, ISO 13485) can, prior to sterilization, have microorganisms on them, albeit in low numbers.

The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform

the non-sterile medical devices into sterile ones.

The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used

to sterilize medical devices 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 that there is always a finite probability that a microorganism survives 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 organisms exist during

treatment. It follows that the sterility of any one medical device in a population of items 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 medical device.

Attention also has to be given to a number of factors, including the microbiological status (bioburden)

of incoming raw materials and/or components and their subsequent storage, and to the control of the

environment in which the product is manufactured, assembled and packaged (see also ISO 13485).

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.

Animal tissues and their derivatives are used as constituents of certain medical devices to provide

performance characteristics that present advantages over the characteristics provided by non-animal-

based materials. The range and quantities of materials of animal origin in medical devices vary; such

materials can comprise a major part of the device, can be a product coating or impregnation, or can be

used in the manufacturing process for the medical device.

This International Standard describes requirements that, if met, will provide a liquid chemical

sterilization process that has appropriate microbicidal activity for single-use medical devices containing

materials of animal origin or their derivatives. The sterilizing agents used most frequently for medical

devices are moist heat, dry heat, irradiation and ethylene oxide. While some devices containing animal

tissues can be compatible with these commonly applied methods of sterilization (historically, for

example, catgut sutures have been sterilized by irradiation), other devices, such as biological heart

valves or tissue patches, are not compatible with conventional sterilization processes. It has been

recognized that other sterilizing agents might have to be used in these exceptional circumstances.

Liquid chemical sterilization is normally chosen over other sterilization processes in order that the

medical devices present the desired physical properties of the tissue after sterilization. Sterilization by

liquid chemicals of medical devices made in whole or in part from tissues of animal origin represents

a special case in terms of establishing an effective sterilization process. In common with the other

sterilization methods, the efficacy of a liquid chemical sterilization process needs to be demonstrated

and recorded before it is adopted for routine use.

Liquid chemical sterilization requires determination of types of microorganisms comprising the

bioburden and their resistance to the sterilization process in order to establish the appropriate reference

microorganism, whether that be a recognized biological indicator or an isolate from the bioburden.

Compliance with the requirements of this International Standard ensures that the microbicidal activity

of the liquid chemical sterilization process is both reliable and reproducible so that predictions can

be made, with reasonable confidence, that there is a low level of probability of there being a viable

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microorganism present on a product after sterilization. Specification of this probability is a matter

for regulatory authorities and can vary among regions or countries (see, for example, EN 556-1 and

ANSI/AAMI ST67).

Exposure to a properly validated, accurately controlled sterilization process is not the only factor

associated with the provision of reliable assurance that the product is sterile and, in this regard,

suitable for its intended use. Attention is therefore given to a number of considerations including:

a) the source and harvesting conditions of the tissue;
b) the microbiological status of incoming raw materials or components, or both;

c) the routine control of any cleaning and disinfection procedures used on the product;

d) the control of the environment in which the product is manufactured, assembled and packaged;

e) the control of equipment and processes;
f) the control of personnel and their hygiene;
g) the manner and materials in which the product is packaged; and
h) the conditions under which product is stored.
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oSIST prEN ISO 14160:2018
DRAFT INTERNATIONAL STANDARD ISO/DIS 14160:2018(E)
Sterilization of health care products — Liquid chemical
sterilizing agents for single-use medical devices utilizing
animal tissues and their derivatives — Requirements for
characterization, development, validation and routine
control of a sterilization process for medical devices
1 Scope

This document specifies requirements for the characterization of a liquid chemical sterilizing agent

and for the development, validation, process control and monitoring of sterilization by liquid chemical

sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.

This document covers the control of risks arising from contamination with bacteria and fungi by

application of a liquid chemical sterilization process. Risks associated with other microorganisms can

be assessed using other methods (see Note 1).
This document is not applicable to material of human origin.

This document does not describe methods for the validation of the inactivation of viruses and

transmissible spongiform encephalopathy (TSE) agents (see Note 2 and Note 3).

This document does not describe methods for validation of the inactivation or elimination of protozoa

and parasites.

The requirements for validation and routine control described in this document are only applicable

to the defined sterilization process of a medical device, which is performed after the manufacturing

process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4).

This document does not specify tests to establish the effects of any chosen sterilization process upon

the fitness for use of the medical device (see Note 5).

This document does not cover the level of residual sterilizing agent within medical devices (see Note 6).

This document does not describe a quality management system for the control of all stages of

manufacture (see Note 7).

NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as

described in ISO 22442-1, is important.

NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices

might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy

(BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate

inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal

materials are described in ISO 22442-2.

NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE

agents is described in ISO 22442-3.

NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include

exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the

manufacturing process, a medical device is exposed to a defined sterilization process.

NOTE 5 Such testing is a crucial part of the design and development of a medical device.

NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.

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NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of

manufacture including the sterilization process.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for

leachable substances

ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a

population of microorganisms on products

ISO 13408-7, Aseptic processing of health care products — Part 7: Alternative processes for medical devices

and combination products devices and combination products

ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 22442-2, Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing,

collection and handling
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
3.1
batch

defined quantity of product, intended or purported to be uniform in character and quality, which has

been produced during a defined cycle of manufacture
[SOURCE: ISO/DIS 11139:2017, 3.21]
3.2
bioburden

population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE: ISO/DIS 11139:2017, 3.23]
3.3
carrier

supporting material on or in which test microorganisms are deposited

[SOURCE: ISO/DIS 11139:2017, 3.33]
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3.4
D value
D value

time or radiation dose required under stated conditions to achieve inactivation of 90 % of a population

of the test microorganisms
[SOURCE: ISO/DIS 11139:2017, 3.77]
3.5
holding time

period during which process parameters are maintained in the load, within their specified tolerances

[SOURCE: ISO/DIS 11139:2017, 3.133]
3.6
inactivation
see microbial inactivation (3.12)
3.7
inactivation curve

graphical representation of inactivation of a population of microorganisms with increasing exposure to

a microbicidal agent under stated conditions
[SOURCE: ISO/DIS 11139:2017, 3.137]
3.8
inoculated carrier
supporting ma
...