EN ISO 14937:2009

SLOVENSKI STANDARD
01-januar-2010
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SIST EN ISO 14937:2001
SIST EN ISO 14937:2001/AC:2004
SIST EN ISO 14937:2001/AC:2005
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Sterilization of health care products - General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization
process for medical devices (ISO 14937:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an
die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung
und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO
14937:2009)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un
agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un
processus de stérilisation pour dispositifs médicaux (ISO 14937:2009)
Ta slovenski standard je istoveten z: EN ISO 14937:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 14937
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.080.01 Supersedes EN ISO 14937:2000
English Version
Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for
medical devices (ISO 14937:2009)
Stérilisation des produits de santé - Exigences générales Sterilisation von Produkten für die Gesundheitsfürsorge -
pour la caractérisation d'un agent stérilisant et pour la mise Allgemeine Anforderungen an die Charakterisierung eines
au point, la validation et la vérification de routine d'un sterilisierenden Agens und an die Entwicklung, Validierung
processus de stérilisation pour dispositifs médicaux (ISO und Lenkung der Anwendung eines Sterilisationsverfahrens
14937:2009) für Medizinprodukte (ISO 14937:2009)
This European Standard was approved by CEN on 24 September 2009.

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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14937:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

Foreword
This document (EN ISO 14937:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 2010.
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 14937:2000.
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 Directives.
For relationship with EU Directives, see informative Annex ZA, B and C, which are integral parts 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, 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 14937:2009 has been approved by CEN as a EN ISO 14937:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable 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 a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable 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 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 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement is
only partly addressed in this European
Standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
Annex ZB
(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 a 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 clauses of
this standard given in Table ZB.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 ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
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.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic 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 a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC on in vitro diagnostic 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 clauses of
this standard given in Table ZC.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 ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

INTERNATIONAL ISO
STANDARD 14937
Second edition
2009-10-15
Sterilization of health care products —
General requirements for characterization
of a sterilizing agent and the
development, validation and routine
control of a sterilization process for
medical devices
Stérilisation des produits de santé — Exigences générales pour la
caractérisation d'un agent stérilisant et pour la mise au point, la
validation et la vérification de routine d'un processus de stérilisation
pour dispositifs médicaux
Reference number
ISO 14937:2009(E)
©
ISO 2009
ISO 14937:2009(E)
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ii © ISO 2009 – All rights reserved

ISO 14937:2009(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
1.1 Inclusions.1
1.2 Exclusions.1
2 Normative references.2
3 Terms and definitions .2
4 Quality management system elements.7
4.1 Documentation .7
4.2 Management responsibility .7
4.3 Product realization .8
4.4 Measurement, analysis and improvement — Control of non-conforming product.8
5 Sterilizing agent characterization .8
5.1 General .8
5.2 Sterilizing agent.8
5.3 Microbicidal effectiveness.8
5.4 Effects on materials .9
5.5 Safety and the environment .9
6 Process and equipment characterization .9
6.1 General .9
6.2 Process characterization.9
6.3 Equipment characterization .10
7 Product definition.10
8 Process definition .11
9 Validation.12
9.1 General .12
9.2 Installation qualification .12
9.3 Operational qualification .13
9.4 Performance qualification .13
9.5 Review and approval of validation .14
10 Routine monitoring and control.14
11 Product release from sterilization .14
12 Maintaining process effectiveness.15
12.1 General .15
12.2 Recalibration.15
12.3 Maintenance of equipment .15
12.4 Requalification.15
12.5 Assessment of change .15
Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating
microbicidal effectiveness.16
Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial
population in its natural state .18
Annex C (normative) Approach 2 — Process definition based on inactivation of reference
microorganisms and knowledge of bioburden .19
ISO 14937:2009(E)
Annex D (normative) Approach 3 — Conservative process definition based on inactivation of
reference microorganisms.20
Annex E (informative) Guidance on application of this International Standard .22
Bibliography .36

iv © ISO 2009 – All rights reserved

ISO 14937:2009(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 14937 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 14937:2000) and ISO 14937:2000/Cor.1:2003
which have been technically revised.
ISO 14937:2009(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. International Standards that 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) could, prior
to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile.
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 generally can best be described by an exponential relationship between the number
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 might 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 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.
This International Standard describes requirements that, if met, will provide a sterilization process with
appropriate microbicidal activity intended to sterilize medical devices. Furthermore, compliance with the
requirements ensures that the 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 medical device after sterilization. Specification of this probability is a matter for
regulatory authorities and can vary from country to country (see, for example, EN 556-1 and
ANSI/AAMI ST67).
Generic requirements of the quality management system for design and development, production, installation
and servicing are given in ISO 9001 and particular requirements for quality management systems for medical
device production are given in ISO 13485. The standards for quality management systems recognise 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.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated
with the provision of reliable assurance that a processed medical device is sterile and, in this regard, suitable
for its intended use. Attention is also given to a number of factors including:
a) the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of any cleaning and disinfection procedures used on the medical device;
c) the control of the environment in which the medical device is manufactured, assembled and packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
f) the manner and materials in which the medical device is packaged;
g) the conditions under which the medical device is stored.
vi © ISO 2009 – All rights reserved

ISO 14937:2009(E)
The type of contamination on a medical device to be sterilized varies, and this influences the effectiveness of
a sterilization process. Medical devices that have been used in a health care setting and that are being
presented for resterilization in accordance with the manufacturer's instructions (see ISO 17664) should be
regarded as special cases. There is the potential for such medical devices to possess a wide range of
contaminating microorganisms and residual inorganic and/or organic contamination in spite of the application
of a cleaning process. Hence, particular attention has to be given to the validation and control of the cleaning
and disinfection processes used during reprocessing.
The requirements are the normative parts of this International Standard with which compliance is claimed. The
guidance given in Annex E is not normative and is not provided as a checklist for auditors. The guidance
provides explanations and methods that are regarded as being a suitable means for complying with the
requirements. Methods other than those given in the guidance can be used if they are effective in achieving
compliance with the requirements of this International Standard.
The development, validation and routine control of a sterilization process comprise a number of discrete but
interrelated activities, for example, calibration, maintenance, product definition, process definition, installation
qualification, operational qualification and performance qualification. While the activities required by this
International Standard have been grouped together and are presented in a particular order, this International
Standard does not require that the activities be performed in the order that they are presented. The activities
required are not necessarily sequential, as the programme of development and validation can be iterative. The
responsibility for carrying out the activities required by this International Standard will vary from case to case.
This International Standard requires that the responsibilities of the various parties be defined (see 4.2) but
does not specify to whom the responsibilities are allocated. Annex E provides guidance on allocation of
responsibility.
This International Standard has three distinct applications:
⎯ for manufacturers of health care products who wish to apply to their products a sterilization process for
which a specific International Standard does not exist;
⎯ for manufacturers and users of sterilization processes in health care settings for which a specific
International Standard does not exist;
⎯ as a framework for the preparation or revision of standards for specific sterilization processes.

INTERNATIONAL STANDARD ISO 14937:2009(E)

Sterilization of health care products — General requirements
for characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for
medical devices
1 Scope
1.1 Inclusions
1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing
agent and for the development, validation and routine monitoring and control of a sterilization process for
medical devices.
NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified
herein can also be applied to sterilization processes for other health care products.
1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated
by physical and/or chemical means.
1.1.3 This International Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for
sterilizing medical devices.
1.1.4 This International Standard specifies the elements of a Quality Management System which are
necessary to assure the appropriate characterization of the sterilizing agent, development, validation and
routine monitoring and control of a sterilization process.
NOTE It is not a requirement of this International Standard to have a full quality management system. The necessary
elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to
the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of
medical devices. National and/or regional regulations for the provision of medical devices might require the
implementation of a full quality management system and the assessment of that system by a third party.
1.2 Exclusions
1.2.1 This International Standard does not apply to sterilization processes that rely solely on physical
removal of microorganisms (for example, filtration).
1.2.2 This International Standard does not describe detailed procedures for assessing microbial inactivation.
1.2.3 This International Standard does not specify requirements for characterization of an agent or for
development, validation and routine control of a process for inactivating the causative agents of spongiform
encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
Specific recommendations have been produced in particular countries for the processing of materials
potentially contaminated with these agents.
NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.4 This International Standard does not supersede or modify published International Standards for
particular sterilization processes.
ISO 14937:2009(E)
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, 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 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General
requirements
ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization process
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical
materials
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[ISO/TS 11139:2006, definition 2.2]
3.2
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[ISO/TS 11139:2006, definition 2.3]
3.3
change control
assessment and determination of the appropriateness of a proposed alteration to product or procedure
[ISO/TS 11139:2006, definition 2.5]
2 © ISO 2009 – All rights reserved

ISO 14937:2009(E)
3.4
chemical indicator
non-biological indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or physical
change resulting from exposure to a process
[ISO/TS 11139:2006, definition 2.6]
3.5
corrective action
action to eliminate the cause of a detected non-conformity or other undesirable situation
NOTE 1 There can be more than one cause for a non-conformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.17) is taken to prevent
occurrence.
NOTE 3 There is a distinction between correction (3.6) and corrective action.
[ISO 9000:2005, definition 3.6.5]
3.6
correction
action to eliminate a detected non-conformity
NOTE A correction can be made in conjunction with a corrective action (3.5).
[ISO 9000:2005, definition 3.6.6]
3.7
development
act of elaborating a specification
[ISO/TS 11139:2006, definition 2.13]
3.8
establish
determine by theoretical evaluation and confirm by experimentation
[ISO/TS 11139:2006, definition 2.17]
3.9
fault
one or more of the process parameters lying outside of its/their specified tolerance(s)
[ISO/TS 11139:2006, definition 2.19]
3.10
health care product(s)
medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including
biopharmaceutical(s)
[ISO/TS 11139:2006, definition 2.20]
ISO 14937:2009(E)
3.11
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]
3.12
material safety data sheet
MSDS
document specifying the properties of a substance, its potential hazardous effects for humans and the
environment, and the precautions necessary to handle and dispose of the substance safely
[ISO/TS 11139:2006, definition 2.23]
3.13
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 purpose(s) 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
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 has been developed by the Global Harmonization Task Force (GHTF 2002).
3.14
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]
3.15
parametric release
declaration that a product is sterile, based on records demonstrating that the process parameters were
delivered within specified tolerances
[ISO/TS 11139:2006, definition 2.29]
4 © ISO 2009 – All rights reserved

ISO 14937:2009(E)
3.16
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 specifications
[ISO/TS 11139:2006, definition 2.30]
3.17
preventive action
action to eliminate the cause of a potential non-conformity or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential non-conformity.
NOTE 2 Preventive action is taken to prevent occurrence, whereas corrective action (3.5) is taken to prevent
recurrence.
[ISO 9000:2005, definition 3.6.4]
3.18
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess performance of
the process
[ISO/TS 11139:2006, definition 2.33]
3.19
process parameter
specified value for a process variable
NOTE The specification for a sterilization process includes the process parameters and their tolerances.
[ISO/TS 11139:2006, definition 2.34]
3.20
process variable
condition within a sterilization process, changes in which alter microbicidal effectiveness
EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength.
[ISO/TS 11139:2006, definition 2.35]
3.21
recognised culture collection
depository authority under the Budapest Treaty on The International Recognition of the Deposit of
Microorganisms for the Purpose of Patent and Regulation
[ISO/TS 11139:2006, definition 2.38]
3.22
reference microorganism
microbial strain obtained from a recognised culture collection
[ISO/TS 11139:2006, definition 2.39]
ISO 14937:2009(E)
3.23
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]
3.24
services
supplies from an external source, needed for the function of equipment
EXAMPLES Electricity, water, compressed air, drainage.
[ISO/TS 11139:2006, definition 2.41]
3.25
specify
stipulate in detail within an approved document
[ISO/TS 11139:2006, definition 2.42]
3.26
sterile
free from viable microorganisms
[ISO/TS 11139:2006, definition 2.43]
3.27
sterility
state of being free from viable microorganisms
NOTE In practice, no such absolute statement regarding the absence of microorganisms can be proven
[see sterilization (3.28)].
[ISO/TS 11139:2006, definition 2.45]
3.28
sterilization
validated process used to render a product free from viable microorganisms
[ISO/TS 11139:2006, definition 2.47]
NOTE In a sterilization process, the nature of microbial inactivation is exponential, and the survival of a
microorganism on an individual item can thus be expressed in terms of probability. While this probability can be reduced to
a very low number, it can never be reduced to zero. (See sterility assurance level in ISO/TS 11139.)
3.29
sterilization load
product to be, or that has been, sterilized using a given sterilization process
[ISO/TS 11139:2006, definition 2.48]
3.30
sterilization process
series of actions or operations needed to achieve the specified requirements for sterility
NOTE This series of actions or operations includes pre-treatment (if necessary), exposure under defined conditions
to the sterilizing agent and any necessary post-treatment. It does not include any cleaning, disinfection or packaging
operations that precede the sterilization process.
[ISO/TS 11139:2006, definition 2.49]
6 © ISO 2009 – All rights reserved

ISO 14937:2009(E)
3.31
sterilizing agent
physical or chemical entity, or combination of entities, that have sufficient microbicidal activity to achieve
sterility under defined conditions
[ISO/TS 11139:2006, definition 2.50]
3.32
survivor curve
graphical representation of the inactivation of a population of microorganisms with increasing exposure to a
microbicidal agent under stated conditions
[ISO/TS 11139:2006, definition 2.51]
3.33
test for sterility
technical operation, defined in a Pharmacopoeia, performed on product following exposure to a sterilization
process or following an aseptic manufacturing process
3.34
test of sterility
technical operation performed as part of development, validation or requalification to determine the presence
or absence of viable microorganisms on product or portions thereof
[ISO/TS 11139:2006, definition 2.54]
3.35
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]
4 Quality management system elements
4.1 Documentation
4.1.1 Procedures for characterization of a sterilizing agent, development, validation, and routine control of a
sterilization process and 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.
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.
ISO 14937:2009(E)
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 product shall be specified. These procedures shall
comply with the applicable clauses of ISO 13485.
4.3.3 A system complying with the applicable clause(s) 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 product
Procedures for control of product 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 sterilizing agent, demonstrate its microbicidal effectiveness, identify
the factors
...