EN ISO 14160:2011

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

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.

Contents Page
Foreword .3

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.
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.

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
ISO 14160:2011(E)
©  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
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Published in Switzerland
ii © ISO 2011 – All rights reserved

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 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

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 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

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.
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

ISO 14160:2011(E)
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 ability of microorganisms to grow and/or multiply
[ISO/TS 11139:2006, definition 2.21]
3.7
inoculated carrier
supporting material on or in which a defined number of viable test organisms have been deposited
3.8
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2006, definition 2.22]
3.9
liquid chemical sterilizing agent
liquid chemical entity, or combination of entities, having sufficient microbicidal activity to achieve sterility under
defined conditions
3.10
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material, or other related article, intended by the manufacturer to be used, alone or in combination, for human
beings for one or more of the specific purposes of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury;
⎯ investigation, replacement, modification or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ control of conception;
⎯ disinfection of medical devices;
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body;
ISO 14160:2011(E)
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[ISO 13485:2003, definition 3.7]
NOTE This definition from ISO 13485:2003 was developed by the Global Harmonization Task Force (GHTF 2002).
3.11
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2006, definition 2.27]
3.12
parametric release
declaration that product is sterile, based on records demonstrating that the process parameters were
delivered within specified tolerances
[ISO/TS 11139:2006, definition 2.29]
3.13
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance
with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product meeting its specification
[ISO/TS 11139:2006, definition 2.30]
3.14
product family
group or subgroup of product characterized by similar attributes such as mass, material, construction, shapes,
lumens and packaging system, and which presents a similar challenge to the sterilization process
[ISO 17665-1:2006, definition 3.38]
3.15
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
[ISO/TS 11139:2006, definition 2.40]
3.16
specify
stipulate in detail within an approved document
[ISO/TS 11139:2006, definition 2.42]
3.17
sterile
free from viable microorganisms
[ISO/TS 11139:2006, definition 2.43]
3.18
sterility
state of being free from viable microorganisms
4 © ISO 2011 – All rights reserved

ISO 14160:2011(E)
[ISO/TS 11139:2006, definition 2.45]
NOTE In practice, no such absolute statement regarding the absence of microorganisms can be proven (see 3.19).
3.19
sterilization
validated process used to render a product free from viable microorganisms
NOTE In a sterilization process, the nature of microbiological inactivation is exponential and thus the survival of a
microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a
very low number, it can never be reduced to zero.
[ISO/TS 11139:2006, definition 2.47]
3.20
storage solution
liquid in which a medical device in its final form is presented for use
3.21
surrogate product
simulation of the item to be sterilized that presents an equal or greater challenge to the sterilization process
3.22
test for sterility
technical operation defined in an official pharmacopoeia performed on product following exposure to a
sterilization process or following an aseptic manufacturing process
[ISO/TS 11139:2006, definition 2.53]
3.23
tissue
organization of cells, cells and extra-cellular constituents, or extra-cellular constituents
3.24
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a process
will consistently yield product complying with predetermined specifications
[ISO/TS 11139:2006, definition 2.55]
NOTE For sterilization by liquid chemical sterilizing agents, validation is considered as a total programme, which
consists of installation qualification, operational qualification and performance qualification.
4 Quality management system elements
4.1 Documentation
4.1.1 Procedures for the development, validation, characterization and routine control of the sterilization
process and for product release from sterilization shall be specified.
4.1.2 Documents and records required by this International Standard shall be reviewed and approved by
designated personnel (see 4.2.1). Documents and records shall be controlled in accordance with the
applicable clauses of ISO 13485.
ISO 14160:2011(E)
4.2 Management responsibility
4.2.1 The responsibility and authority for implementing and meeting the requirements described in this
International Standard shall be specified. Responsibility shall be assigned to competent personnel in
accordance with the applicable clauses of ISO 13485.
4.2.2 If the requirements of this International Standard are undertaken by organizations with separate
quality management systems, the responsibilities and authority of each party shall be specified.
4.3 Product realization
4.3.1 Procedures for purchasing shall be specified. These procedures shall comply with the applicable
clauses of ISO 13485.
4.3.2 Procedures for identification and traceability of the product shall be specified. These procedures shall
comply with the applicable clauses of ISO 13485.
4.3.3 Controls on the sourcing, collection and handling of animal tissues and their derivatives shall be
performed in accordance with ISO 22442-2.
4.3.4 A system complying with the applicable clauses of ISO 13485 or ISO 10012 shall be specified for the
calibration of all equipment, including instrumentation for test purposes, used in meeting the requirements of
this International Standard.
4.4 Measurement, analysis and improvement — Control of non-conforming products
Procedures for control of products designated as non-conforming and for correction, corrective action and
preventive action shall be specified. These procedures shall comply with the applicable clauses of ISO 13485.
5 Sterilizing agent characterization
5.1 General
The purpose of this activity is to define the liquid chemical sterilizing agent, demonstrate its microbicidal
effectiveness, identify the factors which influence microbicidal effectiveness, assess the effects that exposure
to the sterilizing agent has on materials, and identify requirements for the safety of personnel and protection of
the environment.
5.2 Sterilizing agent
5.2.1 The sterilizing agent shall be specified. This specification shall include, if appropriate:
a) the formulation of a sterilizing solution, including concentration of the active agent and pH;
b) an expiration date;
c) a statement that the sterilizing agent shall not be reused;
d) the storage conditions.
The specification for the liquid chemical sterilizing agent should take into account possible contaminants that
could affect the suitability of the processed animal material for its intended use.
5.2.2 The means of ensuring that the sterilizing agent is free from viable microorganisms before use shall
be specified.
6 © ISO 2011 – All rights reserved

ISO 14160:2011(E)
5.3 Microbicidal effectiveness
5.3.1 Microbicidal effectiveness studies shall
a) demonstrate the lethal action of the sterilizing agent against a range of representative microorganisms,
NOTE Guidance on microorganism selection is included in A.6.2 and in Table A.2.
b) identify the process variables that affect the lethal action of the sterilizing agent, e.g. time, temperature,
liquid chemical sterilizing agent concentration and pH (potential interactions of process variables should
be considered),
c) assess those factors that can adversely affect the delivery, or distribution, or both, of the sterilizing agent,
and those that can influence its effectiveness [i.e. the sterilizing agent(s) should be able to reach all areas
since microorganisms could be inside cell/tissue structures], and
d) assess the microbicidal effectiveness of the sterilizing agent at the tolerance limits for the combination of
process variables that results in the lowest microbicidal activity.
5.3.2 The microbicidal effectiveness studies shall include a screening test to identify microorganisms with a
high resistance to the process. This shall include organisms from the product bioburden and the environment,
as well as a reference organism(s) known to be innately resistant to the sterilizing agent.
5.4 Effects on materials
5.4.1 The effects of exposure to the sterilizing agent on the physical, chemical, or physical and chemical
properties of component materials of the medical devices, and on their suitability for use, shall be assessed.
The materials used in the assessment should be selected on the basis of their likely use in products to be
treated with the sterilizing agent.
5.4.2 If the product is to be exposed repeatedly to the sterilizing agent, the effects of such multiple
exposures on properties of component materials using the combination of process parameters likely to
maximize material effects shall be evaluated.
5.4.3 The materials tested and the outcomes of all tests shall be recorded (see 4.1.2), together with the
criteria against which the properties of materials were assessed before and after exposure to the sterilizing
agent.
5.5 Safety and the environment
5.5.1 Either a material safety data sheet (MSDS) or analogous safety information shall be specified for the
sterilizing agent. This MSDS may be provided by a supplier for a chemical agent or be prepared as a prelude
to experimental studies on the sterilizing agent.
5.5.2 The potential impact on the environment of any substance which could be released, either deliberately
or accidentally, during or following use of the sterilizing agent, shall be assessed and measures established
for the control of the substance(s). This assessment, including the potential impact (if any) and the measures
for control (if identified), shall be recorded (see 4.1.2).
6 Process and equipment characterization
6.1 General
The purpose of this activity is to define the entire sterilization process and the equipment necessary to deliver
the sterilization process safely and reproducibly.
ISO 14160:2011(E)
6.2 Process characterization
6.2.1 The process parameters, together with their tolerances, shall be specified. These tolerances shall be
based upon knowledge of the combination of process parameters yielding the minimum effectiveness and
shall yield acceptable product.
6.2.2 Means of monitoring and controlling the process variables shall be specified.
6.2.3 Any treatment of the product that is required prior to exposure to the sterilization process to ensure
effectiveness of the process shall be specified.
6.2.4 Any treatment of the product that is required following exposure to the sterilizing agent to ensure
safety of the product shall be specified as part of the sterilization process.
6.3 Equipment characterization
6.3.1 The equipment to deliver the process within the tolerances stipulated for the process parameters and
in a safe manner shall be specified.
6.3.2 The specification shall include, but is not limited to:
a) a description of the equipment and necessary ancillary items, including materials of construction,
b) the means by which the specified sterilizing agent (see 5.2) is provided, including any additives or
precursors necessary for its delivery (see also 5.2.1),
c) a description of the instrumentation for monitoring and controlling the sterilization process, including
sensor characteristics and locations, indicating and recording instruments,
d) any fault recognition by the sterilizing equipment, if appropriate,
e) any safety features, including those for personnel and environmental protection,
f) the installation requirements, including for the control of emissions, if appropriate, and
g) the conditions for storage of the sterilizing agent within the equipment to ensure that its quality and
composition remain within specifications, if applicable.
6.3.3 Software that is used to control, or to monitor the process shall be prepared and validated in
accordance with a quality management system that provides documented evidence that the software meets
its design specification.
NOTE For guidance, see ISO/IEC 90003.
6.3.4 Means shall be provided to ensure that failure in a control function does not lead to a failure in
recording of process parameters such that an ineffective process appears effective. This may be achieved
either by the use of independent systems for control and monitoring, or by a crosscheck between control and
monitoring which identifies discrepancies and indicates a fault.
7 Product definition
7.1 The purpose of this activity is to define the product to be sterilized by the liquid chemical sterilizing
agent, including the microbiological quality of the product prior to sterilization and the manner in which the
product is presented for sterilization.
8 © ISO 2011 – All rights reserved

ISO 14160:2011(E)
7.2 Product to be sterilized (including dimensions) and its condition shall be specified. This shall include
ancillary components and packaging if applicable, and shall take into account the bioburden and quantity and
types of tissue, and organic and inorganic contamination.
7.3 Product may be assigned to a product family. The criteria for assigning a product to a product family
shall be specified, and shall include consideration of bioburden. A demonstration of equivalence t
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