SIST EN ISO 14160:2011
(Main)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)
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)
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. 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. 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. 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. This International Standard does not cover the level of residual sterilizing agent within medical devices. This International Standard 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)
1.1 Diese Internationale Norm legt die Anforderungen an die Charakterisierung eines flüssigen chemischen Sterilisiermittels und die Entwicklung, Validierung sowie Verfahrenslenkung und überwachung der Sterilisation unter Verwendung flüssiger chemischer Sterilisiermittel von Medizinprodukten für den einmaligen Gebrauch, die ganz oder teilweise aus Materialien tierischen Ursprungs bestehen, fest. Diese Internationale Norm gilt nicht für Materialien menschlichen Ursprungs.
1.2 Diese Internationale Norm beschreibt kein Qualitätsmanagementsystem zur Lenkung aller Stufen des Herstellungsverfahrens.
ANMERKUNG Es wird auf die Normen zu Qualitätsmanagementsystemen (siehe ISO 13485) hingewiesen, die zur Lenkung aller Stufen des Herstellungsverfahrens einschließlich des Sterilisationsverfahrens angewendet werden können.
1.3 Diese Internationale Norm beschreibt keine Prüfungen zur Feststellung der Auswirkungen eines gewählten Sterilisationsverfahrens auf die Gebrauchstauglichkeit des Medizinprodukts.
ANMERKUNG Eine derartige Prüfung ist ein unerlässlicher Bestandteil der Konstruktion und Entwicklung eines Medizinprodukts.
1.4 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.
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 sponiformer Enzephalopathien (TSE), wie z. B. der bovinen spongiformen Enzephalopathie (BSE) oder Scarpie, als unwirksam erweisen.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14160:2011
01-oktober-2011
1DGRPHãþD
SIST EN ISO 14160:2000
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PHGLFLQVNLKSULSRPRþNRY]DHQNUDWQRXSRUDERNLXSRUDEOMDMRåLYDOVNDWNLYDLQ
QMLKRYHGHULYDWH=DKWHYH]DGRORþLWHYODVWQRVWLUD]YRMYDOLGDFLMRLQUXWLQVNR
NRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNHSULSRPRþNH ,62
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
2
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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.
3
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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.
4
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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
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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.
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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
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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.
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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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SIST EN ISO 14160:2011
ISO 14160:2011(E)
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
B
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
2 © ISO 2011 – All rights reserved
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SIST EN ISO 14160:2011
ISO 14160:2011(E)
3.4
D value
D value
10
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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