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 14160:2011)

ISO 14160:2011 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.
ISO 14160:2011 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 need to be assessed.
ISO 14160:2011 is not applicable to material of human origin.
ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents.
ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites.
The requirements for validation and routine control described in ISO 14160:2011 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.
ISO 14160:2011 does not specify tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device.
ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices.
ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.

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 14160:2011)

Diese Internationale Norm legt die Anforderungen an die Charakterisierung eines flüssigen chemischen Sterilisiermittels und die Entwicklung, Validierung sowie Verfahrenslenkung und -überwachung der Sterilisation mit flüssigen chemischen Sterilisiermitteln von Medizinprodukten für den einmaligen Gebrauch, die ganz oder teilweise aus Materialien tierischen Ursprungs bestehen, fest. Diese Internationale Norm behandelt die Kontrolle von Risiken in Bezug auf die Kontamination mit Bakterien und Pilzen durch die Anwendung eines Sterilisationsverfahrens mit flüssigen Chemikalien. Mit anderen Mikroorganismen verbundene Risiken müssen beurteilt werden (siehe Anmerkung 1). Diese Internationale Norm gilt nicht für Materialien menschlichen Ursprungs. Diese Internationale Norm beschreibt keine Verfahren zur Validierung der Inaktivierung von Viren und übertragbarer spongiformer Enzephalopathien (TSE) (siehe Anmerkung 2). Diese Internationale Norm beschreibt keine Verfahren zur Validierung der Inaktivierung und/oder Beseitigung von Protozoen und Parasiten (siehe Anmerkung 3). Die in dieser Internationalen Norm festgelegten Anforderungen an die Validierung und Lenkung der Anwendung gelten nur für das Sterilisationsverfahren, das für ein Medizinprodukt definiert wurde und das im Anschluss an das Herstellungsverfahren durchgeführt wird. Die keimabtötende Wirkung anderer Schritte zur Verringerung der Keimbelastung wird hierbei nicht berücksichtigt (siehe Anmerkung 4). Diese Internationale Norm legt keine Prüfungen zur Feststellung der Auswirkungen eines gewählten Sterilisationsverfahrens auf die Gebrauchstauglichkeit des Medizinprodukts fest (siehe Anmerkung 5). Diese Internationale Norm behandelt nicht die Konzentration von Rückständen der Sterilisiermittel in Medizinprodukten (siehe Anmerkung 6). Diese Internationale Norm beschreibt kein Qualitätsmanagementsystem zur Lenkung aller Stufen des Herstellungsverfahrens (siehe Anmerkung 7). ANMERKUNG 1 Die vorherige Anwendung der Prinzipien des Risikomanagements auf Medizinprodukte, in denen tierische Gewebe verwendet werden, wie in ISO 22442-1 beschrieben, ist wichtig. ANMERKUNG 2 Traditionell zur Sterilisation tierischer Gewebe in Medizinprodukten verwendete flüssige chemische Sterilisiermittel können sich im Hinblick auf die Inaktivierung der Erreger übertragbarer spongiformer Enzephalopathien (TSE), wie z. B. der bovinen spongiformen Enzephalopathie (BSE) oder Scarpie, als unwirksam erweisen. Eine zufrieden-stellende Validierung nach dieser Internationalen Norm dient nicht unbedingt als Nachweis für die Inaktivierung von Infektionserregern dieser Art. Risikokontrollen der Beschaffung, Materialgewinnung und Handhabung von Materialien tierischen Ursprungs sind in ISO 22442-2 beschrieben. ANMERKUNG 3 Die Validierung der Inaktivierung und/oder Eliminierung von Viren und Erregern der übertragbaren spongiformen Enzephalopathie (TSE) ist in ISO 22442-3 beschrieben. ANMERKUNG 4 Herstellungsverfahren von Medizinprodukten, die tierische Gewebe enthalten, schließen häufig die Einwirkung chemischer Wirkstoffe ein, die die Keimbelastung auf einem Medizinprodukt wesentlich verringern können. Im Anschluss an das Herstellungsverfahren wird ein Medizinprodukt einem definierten Sterilisationsverfahren ausgesetzt. ANMERKUNG 5 Eine derartige Prüfung ist ein unerlässlicher Bestandteil der Konstruktion und Entwicklung eines Medizinprodukts. ANMERKUNG 6 Hinsichtlich eines Verfahrens zu Ermittlung zulässiger Grenzwerte für Rückstände von Sterilisiermitteln siehe ISO 10993-17. ANMERKUNG 7 Normen über Qualitätsmanagementsysteme (siehe ISO 13485) können zur Lenkung aller Stufen des Herstellungsverfahrens einschließlich des Sterilisationsverfahrens angewendet werden.

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 14160:2011)

L'ISO 14160:2011 spécifie les exigences relatives à la caractérisation d'un agent stérilisant chimique liquide et à la mise au point, 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.
L'ISO 14160:2011 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 agent chimique liquide. Il est nécessaire d'évaluer les risques associés à d'autres micro-organismes en utilisant d'autres méthodes.
L'ISO 14160:2011 ne s'applique pas aux matières d'origine humaine.
L'ISO 14160:2011 ne décrit pas les méthodes de validation de l'inactivation des virus et des agents d'encéphalopathie spongiforme transmissible.
L'ISO 14160:2011 ne décrit pas les méthodes de validation de l'inactivation et/ou de l'élimination des protozoaires et des parasites.
Les exigences relatives à la validation et au contrôle de routine décrites dans l'ISO 14160:2011 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.
L'ISO 14160:2011 ne spécifie pas les essais destinés à établir les effets qu'un quelconque procédé de stérilisation choisi entraîne sur l'aptitude à l'emploi du dispositif médical.
L'ISO 14160:2011 ne traite pas du taux d'agents stérilisants résiduels dans les dispositifs médicaux.
L'ISO 14160:2011 ne décrit pas le système de management de la qualité nécessaire pour maîtriser toutes les phases de la fabrication.

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 14160:2011)

Ta mednarodni standard določa zahteve za določitev tekočega kemijskega sredstva za sterilizacijo in za razvoj, validacijo, nadzor procesov in nadzorovanje sterilizacije s tekočimi kemijskimi sredstvi za sterilizacijo medicinskih pripomočkov za enkratno uporabo, sestavljenih v celoti ali delno iz materialov živalskega izvora. Ta mednarodni standard zajema nadzor tveganj, ki lahko nastanejo zaradi kontaminacije z bakterijami ali plesnijo z uporabo procesov s tekočimi kemijskimi sredstvi za sterilizacijo. Tveganja, povezana z drugimi mikroorganizmi, so lahko ocenjena z uporabo drugih metod. Ta mednarodni standard ne velja za materiale človeškega izvora. Ta mednarodni standard ne opisuje metod za validacijo inaktivacije virusov in agensov prenosljive spongiformne encefalopatije (TSE). Ta mednarodni standard ne opisuje metod za validacijo inaktivacije ali odstranjevanja protozojev in parazitov. Zahteve za validacijo in rutinsko kontrolo, opisane v tem mednarodnem standardu, veljajo samo za določen sterilizacijski proces medicinskih pripomočkov, ki je izveden po proizvodnem procesu, in ne upošteva smrtonosnih učinkov drugih korakov redukcije biološke obremenitve. Ta mednarodni standard ne določa preskusov za vzpostavitev učinkov katerega koli izbranega sterilizacijskega procesa na primernost uporabe medicinskega pripomočka. Ta mednarodni standard ne zajema količine ostanka sterilizacijskega sredstva v medicinskih pripomočkih. Ta mednarodni standard ne opisuje sistema upravljanja kakovosti za nadzor vseh stopenj proizvodnje.

General Information

Status
Published
Publication Date
30-Jun-2011
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
01-Jul-2011
Completion Date
01-Jul-2011

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SLOVENSKI STANDARD
SIST EN ISO 14160:2011
01-oktober-2011
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SIST EN ISO 14160:2000

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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 14160:2011)
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 14160:2011)

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 14160:2011)
Ta slovenski standard je istoveten z: EN ISO 14160:2011
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN ISO 14160:2011 en

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

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SIST EN ISO 14160:2011
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SIST EN ISO 14160:2011
EUROPEAN STANDARD
EN ISO 14160
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2011
ICS 11.080.01 Supersedes EN ISO 14160:1998
English Version
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 14160:2011)

Stérilisation des produits de santé - Agents stérilisants Sterilisation von Produkten für die Gesundheitsfürsorge -

chimiques liquides pour dispositifs médicaux non
Flüssige chemische Sterilisiermittel für Medizinprodukte für

réutilisables utilisant des tissus animaux et leurs dérivés - den einmaligen Gebrauch, bei denen tierische Gewebe und

Exigences pour la caractérisation, le développement, la deren Derivate verwendet werden - Anforderungen an die

validation et le contrôle de routine d'un procédé de Charakterisierung, Entwicklung, Validierung und Lenkung

stérilisation de dispositifs médicaux (ISO 14160:2011) der Anwendung eines Sterilisationsverfahrens für

Medizinprodukte (ISO 14160:2011)
This European Standard was approved by CEN on 30 June 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14160:2011: E

worldwide for CEN national Members.
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SIST EN ISO 14160:2011
EN ISO 14160:2011 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 14160:2011
EN ISO 14160:2011 (E)
Foreword

This document (EN ISO 14160:2011) 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 January 2012, and conflicting national standards shall be withdrawn at

the latest by January 2012.

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 14160:1998.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive.

For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO 14160:2011 has been approved by CEN as a EN ISO 14160:2011 without any modification.

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SIST EN ISO 14160:2011
EN ISO 14160:2011 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide one means of conforming to Essential Requirements of

the New Approach Directive 93/42/EEC on Medical Devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the normative clauses of

this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
european Standard Directive 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 8.4

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling

within the scope of this Standard.
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SIST EN ISO 14160:2011
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SIST EN ISO 14160:2011
INTERNATIONAL ISO
STANDARD 14160
Second edition
2011-07-01
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
Reference number
ISO 14160:2011(E)
ISO 2011
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SIST EN ISO 14160:2011
ISO 14160:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
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SIST EN ISO 14160:2011
ISO 14160:2011(E)
Contents Page

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

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

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

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

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

4 Quality management system elements...............................................................................................5

4.1 Documentation ......................................................................................................................................5

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

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

4.4 Measurement, analysis and improvement — Control of non-conforming products......................6

5 Sterilizing agent characterization ........................................................................................................6

5.1 General ...................................................................................................................................................6

5.2 Sterilizing agent.....................................................................................................................................6

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

5.4 Effects on materials ..............................................................................................................................7

5.5 Safety and the environment .................................................................................................................7

6 Process and equipment characterization ...........................................................................................7

6.1 General ...................................................................................................................................................7

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

6.3 Equipment characterization .................................................................................................................8

7 Product definition..................................................................................................................................8

8 Process definition .................................................................................................................................9

8.1 Purpose ..................................................................................................................................................9

8.2 Determination of the inactivation kinetics..........................................................................................9

8.3 Method for neutralization....................................................................................................................10

8.4 Safety quality and performance.........................................................................................................10

9 Validation..............................................................................................................................................10

9.1 General .................................................................................................................................................10

9.2 Installation qualification .....................................................................................................................11

9.3 Operational qualification ....................................................................................................................11

9.4 Performance qualification ..................................................................................................................11

9.5 Review and approval of validation ....................................................................................................13

10 Routine monitoring and control.........................................................................................................14

11 Product release from sterilization .....................................................................................................16

12 Maintaining process effectiveness....................................................................................................16

12.1 General .................................................................................................................................................16

12.2 Maintenance of equipment .................................................................................................................16

12.3 Requalification.....................................................................................................................................16

12.4 Assessment of change .......................................................................................................................17

Annex A (informative) Guidance for the application of this International Standard..................................18

Annex B (normative) Determination of lethal rate of the sterilization process ..........................................29

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

Clause 8), and microbiological performance qualification (see 9.4.2)...........................................33

Bibliography......................................................................................................................................................34

© ISO 2011 – All rights reserved iii
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SIST EN ISO 14160:2011
ISO 14160:2011(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 14160 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This second edition cancels and replaces the first edition (ISO 14160:1998), which has been technically

revised.
iv © ISO 2011 – All rights reserved
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SIST EN ISO 14160:2011
ISO 14160:2011(E)
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) may, 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 may 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 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 may 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

© ISO 2011 – All rights reserved v
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SIST EN ISO 14160:2011
ISO 14160:2011(E)

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 microorganism present on a product

after sterilization. Specification of this probability is a matter for regulatory authorities and may 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.
vi © ISO 2011 – All rights reserved
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SIST EN ISO 14160:2011
INTERNATIONAL STANDARD ISO 14160:2011(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 International Standard 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 International Standard 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 International Standard is not applicable to material of human origin.

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

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

This International Standard 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 International Standard 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 International Standard 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 International Standard does not cover the level of residual sterilizing agent within medical devices (see

Note 6).

This International Standard 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 International Standard 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.
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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.

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 referenced documents are indispensable for the application 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, Measure 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 medical devices — Microbiological methods — Part 1: Determination of a

population of microorganisms on products
ISO 13408 (all parts), Aseptic processing of health care products

ISO 13485:2003, 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.
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
[ISO/TS 11139:2006, definition 2.1]
3.2
bioburden

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

[ISO/TS 11139:2006, definition 2.2]
3.3
carrier
supporting material on or in which test microorganisms are deposited
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3.4
D value
D value

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

exposure conditions
[ISO/TS 11139:2006, definition 2.11]
3.5
exposure time

period for which the process parameters are maintained within their specified tolerances

[ISO/TS 11139:2006, definition 2.18]
3.6
inactivation
loss of the abili
...

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