SIST EN ISO 14160:2021
(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 14160:2020)
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 14160:2020)
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 14160:2020)
Dieses Dokument legt die Anforderungen an die Charakterisierung eines flüssigen chemischen sterilisierenden Agens und die Entwicklung, Validierung sowie Verfahrenslenkung und überwachung der Sterilisation mit flüssigen chemischen sterilisierenden Agenzien von Medizinprodukten für den Einmalgebrauch, die ganz oder teilweise aus Materialien tierischen Ursprungs bestehen, fest.
Dieses Dokument behandelt die Lenkung von Risiken in Bezug auf die Kontamination mit Bakterien und Pilzen durch die Anwendung eines Sterilisationsverfahrens mit flüssigen Chemikalien. Mit anderen Mikro¬organismen verbundene Risiken können mit anderen Verfahren beurteilt werden (siehe Anmerkung 1).
Dieses Dokument gilt nicht für Materialien menschlichen Ursprungs.
Dieses Dokument beschreibt keine Verfahren zur Validierung der Inaktivierung von Viren und von übertragbaren spongiformen Enzephalopathien (TSE) (siehe Anmerkung 2 und Anmerkung 3).
Dieses Dokument beschreibt keine Verfahren zur Validierung der Inaktivierung oder Beseitigung von Protozoen und Parasiten.
Die in diesem Dokument 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 abtötende Wirkung anderer Schritte zur Verringerung des Bioburden wird hierbei nicht berücksichtigt (siehe Anmerkung 4).
Dieses Dokument legt keine Prüfungen zur Ermittlung der Auswirkungen eines gewählten Sterilisations¬verfahrens auf die Gebrauchstauglichkeit des Medizinprodukts fest (siehe Anmerkung 5).
Dieses Dokument behandelt nicht die Konzentration von Rückständen sterilisierender Agenzien in Medizinprodukten (siehe Anmerkung 6).
Eine Anleitung für die Charakterisierung eines flüssigen chemischen sterilisierenden Agens und für die Entwicklung, Validierung, Prozesssteuerung und Überwachung der Sterilisation von Medizinprodukten für den Einmalgebrauch, die ganz oder teilweise aus Materialien tierischen Ursprungs bestehen, durch flüssige chemische sterilisierende Agenzien ist im informativem Anhang A enthalten.
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. ISO 18362 stellt Informationen zur Kontrolle der mikrobiellen Risiken während der Verarbeitung von zellbasierten Gesundheitsprodukten bereit.
[...]
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 14160:2020)
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 14160:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14160:2021
01-september-2021
Nadomešča:
SIST EN ISO 14160:2011
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 14160:2020)
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 14160:2020)
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 14160:2020)
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 14160:2020)
Ta slovenski standard je istoveten z: EN ISO 14160:2021
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN ISO 14160:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14160:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 14160:2011
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
14160:2020)
Stérilisation des produits de santé - Agents stérilisants Sterilisation von Produkten für die
chimiques liquides pour dispositifs médicaux non Gesundheitsfürsorge - Flüssige chemische
réutilisables utilisant des tissus animaux et leurs Sterilisiermittel für Medizinprodukte für den
dérivés - Exigences pour la caractérisation, le einmaligen Gebrauch, bei denen tierische Gewebe und
développement, la validation et le contrôle de routine deren Derivate verwendet werden - Anforderungen an
d'un procédé de stérilisation de dispositifs médicaux die Charakterisierung, Entwicklung, Validierung und
(ISO 14160:2020) Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO
14160:2020)
This European Standard was approved by CEN on 24 December 2018.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14160:2021 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 5
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
European foreword
This document (EN ISO 14160:2021) 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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14160:2011.
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(s).
For the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between undated normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10012 EN ISO 10012:2003 ISO 10012:2003
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-17 EN ISO 10993-17:2009 ISO 10993-17:2002
ISO 11737-1 EN ISO 11737-1:2018 ISO 11737-1:2018
ISO 13408-7 EN ISO 13408-7:2015 IISO 13408-7:2015
ISO 13485 EN ISO 13485:2016 ISO 13485:2016
ISO 22442-2 EN ISO 22442-2:2015 ISO 22442-2:2015
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
NOTE 2 Many of the standards normatively referred to by ISO 14160 are undated. These referred standards
also include normative references themselves to other dated and undated standards. For undated normative
references, it should always be assumed that the latest edition applies. For example, EN ISO 14160 refers to
ISO 10993-1 which itself normatively refers to ISO 14971. In Europe, it should be presumed that the reference to
ISO 14971 is to EN ISO 14971:2012.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14160:2020 has been approved by CEN as EN ISO 14160:2021 without any modification.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European Standard has been prepared under a Commission’s standardization request to provide
one voluntary means of conforming to General Safety and Performance Requirements of
Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
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 General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 – Correspondence between this European standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
11.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using liquid chemical
sterilizing agents for single-use
medical devices utilizing animal
tissues and their derivatives,
including requirements that the
medical device is safe and
performs as intended after
treatment. It could also be applied
to the development, validation and
routine control of a process for
attainment of a specific microbial
5
---------------------- Page: 7 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
state other than sterility.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of a specific
microbial state during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of a specific microbial
state using liquid chemical
sterilizing agents for single-use
medical devices utilizing animal
tissues and their derivatives are
not covered.
11.4 first sentence only 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using liquid chemical
sterilizing agents for single-use
medical devices utilizing animal
tissues and their derivatives,
including requirements that the
medical device is safe and
performs as intended after
treatment.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of sterility using liquid
chemical sterilizing agents for
single-use medical devices
utilizing animal tissues and their
derivatives are not covered.
Evidence that the integrity of the
packaging is maintained to the
point of use is not covered.
11.5 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process for medical devices using
liquid chemical sterilizing agents
for single-use medical devices
utilizing animal tissues and their
derivatives.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
6
---------------------- Page: 8 ----------------------
SIST EN ISO 14160:2021
EN ISO 14160:2021 (E)
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of sterility using liquid
chemical sterilizing agents for
single-use medical devices
utilizing animal tissues and their
derivatives are not covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
7
---------------------- Page: 9 ----------------------
SIST EN ISO 14160:2021
---------------------- Page: 10 ----------------------
SIST EN ISO 14160:2021
INTERNATIONAL ISO
STANDARD 14160
Third edition
2020-09
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 14160:2020(E)
©
ISO 2020
---------------------- Page: 11 ----------------------
SIST EN ISO 14160:2021
ISO 14160:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 14160:2021
ISO 14160:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 6
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 .13
9.4.1 General.13
9.4.2 Microbiological performance qualification (MPQ) .13
9.4.3 Physical performance qualification .14
9.4.4 Aseptic processing qualification .15
9.5 Review and approval of validation .15
10 Routine monitoring and control .16
11 Product release from sterilization .17
12 Maintaining process effectiveness .17
12.1 General .17
12.2 Maintenance of equipment .18
12.3 Requalification .18
12.4 Assessment of change .18
Annex A (informative) Guidance for the application of this document .19
Annex B (normative) Determination of lethal rate of the sterilization process .31
Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3), process definition
(see Clause 8), and microbiological performance qualification (see 9.4.2) .35
Bibliography .36
© ISO 2020 – All rights reserved iii
---------------------- Page: 13 ----------------------
SIST EN ISO 14160:2021
ISO 14160:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
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 regard to applying the overkill approach.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14160:2021
ISO 14160:2020(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) have microorganisms on them prior to sterilization, 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
...
SLOVENSKI STANDARD
oSIST prEN ISO 14160:2018
01-junij-2018
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY7HNRþDNHPLMVNDVUHGVWYD]DVWHULOL]DFLMR
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.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 14160:2018
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
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
© ISO 2018 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
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
iv © ISO 2018 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This third edition cancels and replaces the second edition (ISO 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.
© ISO 2018 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(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) 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
vi © ISO 2018 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
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.
© ISO 2018 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 14160:2018
---------------------- Page: 10 ----------------------
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.
© ISO 2018 – All rights reserved 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
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]
2 © ISO 2018 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 14160:2018
ISO/DIS 14160:2018(E)
3.4
D value
D value
10
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.