EN ISO 14937:2000

SLOVENSKI STANDARD
01-november-2001
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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 14937:2000)
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an
die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und
Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO
14937:2000)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un
agent stérilisant et pour le développement, la validation et la vérification de routine d'un
processus de stérilisation pour dispositifs médicaux (ISO 14937:2000)
Ta slovenski standard je istoveten z: EN ISO 14937:2000
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.

INTERNATIONAL ISO
STANDARD 14937
First edition
2000-12-15
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 le développement, la validation
et la vérification de routine d'un processus de stérilisation pour dispositifs
médicaux
Reference number
ISO 14937:2000(E)
©
ISO 2000
ISO 14937:2000(E)
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ii © ISO 2000 – All rights reserved

ISO 14937:2000(E)
Contents Page
Foreword.v
Introduction.vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Quality system elements.5
4.1 General.5
4.2 Assignment of responsibilities .5
4.3 Documentation and records.5
4.4 Design control.6
4.5 Calibration .6
5 Sterilizing agent characterization .6
5.1 General.6
5.2 Sterilizing agent .6
5.3 Microbicidal effectiveness .6
5.4 Material effects.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
9 Validation.10
9.1 General.10
9.2 Installation qualification.10
9.3 Operational qualification.11
9.4 Performance qualification.11
9.5 Review and approval of validation.12
10 Routine monitoring and control.12
11 Product release from sterilization.12
12 Maintaining process effectiveness .12
12.1 General.12
12.2 Maintenance of equipment .13
12.3 Requalification .13
12.4 Assessment of change.13
Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating
microbicidal effectiveness.14
Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial
population in its natural state.16
Annex C (normative) Approach 2 — Process definition based on inactivation of reference
microorganisms and knowledge of bioburden on product items to be sterilized.17
Annex D (normative) Approach 3 — Conservative process definition based on inactivation of
reference microorganisms.18
ISO 14937:2000(E)
Annex E (informative) Guidance on application of this International Standard .20
Annex ZA (informative) Corresponding International and European Standards.33
Bibliography .34
iv © ISO 2000 – All rights reserved

ISO 14937:2000(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 14937 was prepared by Technical Committee ISO/TC 198, Sterilization of health care
products.
Annexes A, B, C and D form a normative part of this International Standard. Annexes E and ZA are for information
only.
ISO 14937:2000(E)
Introduction
A sterile medical device is one which is free of viable microorganisms. When it is necessary to supply a sterile medical
device, International Standards specifying requirements for validation and routine control of sterilization processes
require 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
systems (see, for example, ISO 13485 and ISO 13488) or which have been subjected to a cleaning process as part of
their reprocessing in a health care establishment may, prior to sterilization, have microorganisms on them, albeit in low
numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants
and thereby transform the non-sterile products 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 product in a population
subjected to sterilization processing cannot be guaranteed, and the sterility of a processed population has to be defined
in terms of the probability of there being a viable microorganism present on a product.
This International Standard describes requirements which will enable sterilizer manufacturers, medical device
manufacturers and health care facilities to demonstrate that a process intended to sterilize medical devices has
appropriate microbicidal activity, and that this activity is both reliable and reproducible, such that the relationship for the
inactivation of microorganisms can be extrapolated with reasonable confidence to low levels of probability of there
being a viable microorganism present on a product after sterilization processing. This International Standard does not
specify the maximal value to be taken by this probability; specification of this probability is a matter for regulatory
authorities and may vary from country to country (see, for example, EN 556 and AAMI ST67).
Generic requirements of the quality system for design/development, production, installation and servicing are given in
the ISO 9000 series and particular requirements for quality systems for medical device production in ISO 13485 and
ISO 13488. The standards for quality systems recognize that, for certain processes used in manufacturing or
reprocessing, 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 monitored routinely and the equipment maintained.
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 respect, suitable for its intended use. Attention is
given to a number of factors, including:
a) for a manufacturing process, the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of the cleaning and disinfection procedures used during reprocessing;
c) the control of the environment in which the product is manufactured, assembled and packaged, together with
control of personnel and their hygiene; and,
d) the manner in which the items are packaged and the conditions under which the sterilized items are stored.
The type of contamination on a product to be sterilized varies, and this impacts upon the effectiveness of a sterilization
process. Products that have been used in a health care setting, and are being presented for resterilization in
accordance with the manufacturer's instructions, should be regarded as a special case. There is the potential for such
products 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 is given to the validation and
control of the cleaning and disinfection processes used during reprocessing.
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ISO 14937:2000(E)
Sterilization technology is at several levels of development and application. There are processes which are developed
and have been in use for appreciable periods, and there are processes which are being developed and introduced
either for sterilization of specific products or for general application. Furthermore, there may be processes which have
yet to be discovered. Experience has identified the requirements which are appropriate for existing sterilization
technologies, and these requirements have been specified in International Standards specific to each established
process. The intention in developing this International Standard is to use this experience to provide, for suppliers of
sterilization technologies, to their users and to regulatory authorities, a knowledge of the relevant general requirements
that will allow development of additional sterilization technologies to continue within a broad framework until sufficient
experience, confidence and demand exist to justify the preparation of a specific International Standard.
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; and,
� for manufacturers and users of sterilization systems in health care settings for which a specific International
Standard does not exist; and,
� to provide a framework for the preparation or revision of standards for specific sterilization processes.
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 4.1.1) but does not
specify to whom the responsibilities are allocated. Annex E provides guidance on allocation of responsibility.
INTERNATIONAL STANDARD ISO 14937:2000(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 This International Standard specifies general requirements for the characterization of a sterilizing agent, and
for the development, validation and routine control of a sterilization process for medical devices.
1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by
physical and/or chemical means.
1.3 This International Standard does not apply to processes that rely solely on physical removal of
microorganisms (for example, filtration).
1.4 This International Standard does not describe detailed test procedures for assessing microbial inactivation.
1.5 This International Standard is intended to be applied by process developers, manufacturers of sterilization
equipment, manufacturers of medical devices to be sterilized and the organization with responsibility for sterilizing
the medical device.
1.6 This International Standard does not supersede or modify published International Standards for particular
sterilization processes.
NOTE 1 Although the scope of this International Standard is limited to medical devices, the principles described may also be
applied to other health care products.
NOTE 2 Sterilization processes validated and controlled in accordance with the requirements of this International Standard
should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie,
bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular
countries for the processing of materials potentially contaminated with these agents.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 10012-1, Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system
for measuring equipment.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable
substances using health-based risk assessment.
ISO 14937:2000(E)
ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General.
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: Estimation of population of
microorganisms on products.
ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in
the validation of a sterilization process.
ISO 13485, Quality systems — Medical devices — Particular requirements for the application of ISO 9001.
ISO 13488, Quality systems — Medical devices — Particular requirements for the application of ISO 9002.
IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1:
General requirements.
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 a product and/or a package
3.2
biological indicator
microbiological test system providing a defined resistance to a specified sterilization process
3.3
change control
formal assessment and determination of the appropriateness of a proposed alteration to product or procedure
3.4
chemical indicator
system that reveals a change in one or more predefined process variables based on a chemical or physical change
resulting from exposure to a process
3.5
development
act of elaborating a specification in preparation for validation
3.6
establish
determine by theoretical evaluation and confirm by experimentation
3.7
fault
one or more of the process parameters which lies outside of its/their specified tolerance(s)
3.8
health care product
medical device, medicinal product (pharmaceuticals and biologics) or in vitro diagnostic medical device
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ISO 14937:2000(E)
3.9
installation qualification
IQ
obtaining and documenting evidence that equipment has been provided and installed in accordance with its
specification
3.10
material safety data sheet
document specifying the properties of a material, its potential hazardous effects for humans and the environment,
and the precautions necessary to handle and dispose of the material safely
3.11
medical device
any instrument, apparatus, appliance material or other article, whether used alone or in combination, including the
software necessary for its proper application intended by the manufacturer to be used for human beings for the
purpose of:
� diagnosis, prevention, monitoring, treatment or alleviation of disease;
� diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
� investigation, replacement or modification of the anatomy or of a physiological process;
� control of conception;
and which does not achieve its principal 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
3.12
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when
used in accordance with its operational procedures
3.13
parametric release
declaration that a product is sterile, based on the records demonstrating that the process parameters were
delivered within specified tolerances
3.14
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
3.15
process challenge device
item designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process,
and used to assess the effective performance of the process
3.16
process parameter
specified value for a process variable
NOTE The specification for a sterilization process includes the process parameters and their tolerances.
ISO 14937:2000(E)
3.17
process variable
condition associated with a sterilization process, changes in which alter microbicidal effectiveness
NOTE Process variables may include, for example, time, temperature, pressure, concentration, humidity, wavelength.
3.18
recognized culture collection
international depository authority under the Budapest Treaty on ‘The International Recognition of the Deposit of
Microorganisms for the Purpose of Patent and Regulation’
3.19
reference microorganism
microbial strain obtained from a recognized culture collection
3.20
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
3.21
services
supplies from an external source, necessary for the correct functioning of sterilizing equipment
NOTE Examples of services are electricity, water, compressed air, and drainage.
3.22
specify
stipulate in detail within an approved document
3.23
sterile
free from viable microorganisms
3.24
sterility
state of being free from viable microorganisms
3.25
sterilization
validated process used to render a product free from viable microorganisms
3.26
sterilization load
product to be, or that has been, sterilized together using a given sterilization process
3.27
sterilization process
series of actions or operations to achieve the specified requirements for sterility
NOTE This series of actions or operations includes pre-treatment (if necessary), exposure to the sterilizing agent under
defined conditions and any necessary post-treatment. It does not include any cleaning, disinfection or packaging operations that
precede the sterilization process.
3.28
sterilizing agent
physical or chemical entity, or combination of entities, that have sufficient microbicidal activity to achieve sterility
under defined conditions
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ISO 14937:2000(E)
3.29
survivor curve
graphical representation of the inactivation of a population of microorganisms with increasing exposure to a
microbicidal agent under stated conditions
3.30
test for sterility
test defined in an official Pharmacopoeia for product release following exposure to a sterilization process
3.31
test of sterility
test performed as part of development, validation or requalification to establish the presence or absence of viable
microorganisms on product units, or portions thereof
3.32
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a process will
consistently yield product complying with predetermined specifications
4 Quality system elements
4.1 General
The purpose of the quality system is to define and document procedures, the implementation of which control all
stages of development, application and use of the sterilization process. It is not a requirement of this International
Standard to have a complete quality system during design/development and production, but certain elements of a
quality system are required and these are normatively referenced at appropriate places in the text. Attention is
drawn to ISO 9001 and ISO 13485 which describe a quality system. This International Standard does not require
third party assessment of the specified quality system elements.
4.2 Assignment of responsibilities
4.2.1 The responsibility for performing each element of the procedures in this International Standard shall be
defined and documented. Responsibility for each element may vary from case to case and this International
Standard does not allocate responsibility for each element to particular parties.
The elements are: quality system; sterilizing agent characterization; process/equipment characterization; product
definition; process definition; validation; routine monitoring and control; product release from sterilization; and
maintaining process effectiveness.
NOTE These elements are illustrated in Table E.1.
4.2.2 Responsibilities shall be further assigned to qualified personnel as specified in ISO 13485 or ISO 13488.
NOTE 4.1.1, 4.1.2.2 and 4.18 of ISO 13485:1996 and ISO 13488:1996 detail requirements for management responsibility,
personnel and training.
4.3 Documentation and records
4.3.1 Documented procedures for each phase of the development, validation, routine monitoring and control
and product release from sterilization shall be prepared and implemented.
ISO 14937:2000(E)
4.3.2 Documentation and records required by this International Standard shall be reviewed and approved by
designated personnel (see 4.1.2). A system shall be prepared, documented and maintained to control all
procedures and records required by this International Standard. This system shall comply with ISO 13485 or
ISO 13488.
4.3.3 Records of development, validation, routine monitoring and control and product release from sterilization
activities shall be retained.
4.3.4 The records required by this International Standard shall be retained in accordance with ISO 13485 or
ISO 13488.
NOTE 4.4.6 of ISO 13485:1996 and ISO 13488:1996 detail requirements for retention of records.
4.4 Design control
Characterization of the sterilizing agent and sterilization process shall be undertaken in accordance with a
documented plan. At defined stages, design reviews shall be planned, conducted and documented.
NOTE 4.4.6 of ISO 13485:1996 details requirements for design reviews.
4.5 Calibration
A documented system, complying with ISO 13485, ISO 13488 or ISO 10012-1, shall be established and maintained
for the calibration of all equipment, including instrumentation for test purposes, used in meeting the requirements of
this International Standard.
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 which influence microbicidal effectiveness, assess the effects that exposure to the sterilizing agent have on
materials, and identify requirements for safety of personnel and protection of the environment. This activity may be
undertaken in a test or prototype system; the final equipment specification (see 6.3) should be relatable to the
experimental studies undertaken using any such test or prototype equipment.
5.2 Sterilizing agent
A specification for the sterilizing agent shall be generated and documented. This shall include, if appropriate,
conditions for storage to maintain the sterilizing agent within its specification for the duration of any stated shelf life.
5.3 Microbicidal effectiveness
5.3.1 Microbicidal effectiveness studies shall
a) demonstrate the lethal action of the sterilizing agent against a representative range of microorganisms
selected in accordance with annex A,
b) establish an empirical mathematical relationship defining the microbial inactivation kinetics of identified
resistant microorganisms, and confirm that the probability of a microorganism surviving exposure to a defined
treatment can be validly predicted.
c) select reference microorganism(s), based on the microbial inactivation kinetics, which have known high
resistance(s) to the sterilizing agent for use in establishing the sterilization process,
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ISO 14937:2000(E)
d) identify the process variables which affect the lethal action of the sterilizing agent and the interactions of these
process variables in relation to this lethal action,
e) assess those factors that can adversely affect the delivery and/or distribution of the sterilizing agent,
NOTE Such factors may include, for example, the environment, packaging configuration(s), geometry, materials and
residues from manufacturing, cleaning and/or disinfection.
f) assess those factors that can adversely influence the effectiveness of the sterilizing agent based upon physical
and/or chemical interactions.
NOTE Such factors may include, for example, interactions with materials and residues from manufacturing, cleaning
and/or disinfection.
g) identify a means for terminating the activity of the sterilizing agent, if applicable.
5.3.2 The test method(s), acceptance criteria, test results and justification for the choice of test microorganisms
shall be documented.
5.4 Material effects
5.4.1 The effects of exposure to the sterilizing agent on the physical and/or chemical properties of materials,
and on their biological safety shall be assessed. The materials should be selected on the basis of the likely usage
of the sterilizing agent.
5.4.2 The effects of repeated exposure to the sterilizing agent on properties of materials using the combination
of process parameters likely to maximize material effects shall be studied.
5.4.3 The materials tested and the outcomes of all tests shall be documented, 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 or analogous safety information shall be prepared and documented for
the sterilizing agent, its precursors (if any) and any by-products of the sterilizing agent. This material safety data
sheet 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 for its control
determined. This assessment, including the potential impact (if any) and the measures for control (if identified) shall
be documented.
NOTE ISO 14001 provides a specification for an environmental management system. ISO 14040 provides guidance on
designing a life cycle assessment study.
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 14937:2000(E)
6.2 Process characterization
6.2.1 The process parameters, together with their tolerances, shall be established and documented. These
tolerances shall be based upon knowledge of the combination of process parameters yielding the minimum
acceptable microbicidal effectiveness, and shall yield acceptable product.
NOTE The establishment of the process parameters comprises the definition of process variables, including those that are
excluded or minimized in ensuring the effectiveness of the sterilization process.
6.2.2 Means of monitoring and controlling the process variables shall be determined.
6.2.3 Any treatment of product that is required prior to exposure to the sterilization process to ensure the
effectiveness of the process shall be defined and documented.
6.2.4 Any treatment of product that is required following exposure to the sterilizing agent to ensure the safety of
the product shall be defined as part of the sterilization process and documented.
6.3 Equipment characterization
6.3.1 The specification for equipment to deliver the process within the tolerances stipulated for the process
parameters and in a safe manner shall be established and documented.
6.3.2 The specification shall include but is not limited to
a) physical description of the equipment, together with any necessary ancillary items, including materials of
construction,
b) specification of the sterilizing agent and the means by which it is provided, including any additives or
precursors necessary for its delivery,
c) description of instrumentation for monitoring and controlling the sterilization process, including sensor
characteristics and locations, indicating and recording instruments,
d) fault recognized by the sterilizing equipment,
e) safety features, including those for personnel and environmental protection,
f) installation requirements, including for the control of emissions, if applicable.
6.3.3 Software used to control and/or monitor the process shall be prepared in accordance with a quality system
that provides documented evidence that the software meets its design intention.
NOTE Attention is drawn to ISO 9000-3.
6.3.4 Means shall be provided to ensure that a 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 a cross-check between control and monitoring which
identifies any discrepancies and indicates a fault.
7 Product definition
7.1 The purpose of this activity is to define the product to be sterilized, including the microbiological quality of the
product prior to sterilization and the manner in which product is packaged and presented for sterilization.
7.2 Product to be sterilized, including the packaging materials to be used and the manner in which product is to
be presented to the sterilizing agent, shall be defined and documented.
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ISO 14937:2000(E)
Meeting this requirement could necessitate that appropriate information be provided to the organization
undertaking the sterilization process by the manufacturer of the medical device and the manufacturer of the
sterilization equipment.
7.3 A system shall be defined, documented and maintained to ensure that the condition of the product presented
for sterilization, including microbiological, organic and inorganic contamination levels, is controlled and does not
compromise the effectiveness of the sterilization process.
7.4 The effectiveness of the system defined in accordance with 7.3 shall be demonstrated. For medical devices
to be supplied for single use, this demonstration shall include estimation of bioburden in accordance with
ISO 11737-1. For medical devices to be reprocessed, this demonstration shall include assessment of the
effectiveness of the specified cleaning, and if applicable, disinfecting process.
The intention is that bioburden be stable and low, given the nature of the raw materials, product and manufacturing
or reprocessing procedures prior to sterilization. This can be achieved by employing a quality system complying
with ISO 13485 or ISO 13488 throughout the manufacture of the medical device, or by employing a defined and
controlled cleaning process of demonstrated effectiveness, together with a disinfection process (if specified) prior to
sterilization, and thereafter preventing recontamination of the medical device.
NOTE International Standards for equipment to be used in cleaning and disinfecting medical devices prior to sterilization
are in the course of preparation. These International Standards will include methods to demonstrate the effectiveness of a
cleaning and disinfecting process.
8 Process definition
8.1 The purpose of this activity is to obtain a detailed specification for the sterilization process to be applied to
defined product (see clause 7), without compromising the safety, quality and performance of that product.
8.2 The sterilization process applicable for defined product shall be established. This shall be achieved by
a) if practical, demonstrating the attainment of the process parameters by measurements, and
b) delivering the sterilizing agent under conditions so designed to represent increments of treatments that deliver
less lethality than the intended sterilization process using one of the approaches outlined in annexes B, C or D
to this standard.
8.3 If biological indicators are used as part of the establishment of the sterilization process, these shall
a) comply with ISO 11138-1 and any subsequent parts of ISO 11138 which are applicable to the sterilization
process,
b) be shown to be resistant to the sterilizing agent relative to the bioburden of product to be sterilized, and
c) be placed at positions in product where it has been determined that sterilizing conditions are most difficult to
achieve.
8.4 If chemical indicators are used as part of the establishment of the sterilization process, these shall comply
with ISO 11140-1 and any subsequent parts of ISO 11140 which are applicable to the process and shall be placed
at positions in product where it has been determined that sterilizing conditions are most difficult to achieve.
8.5 If tests of sterility are performed during the establishment of the sterilization process, such tests shall comply
with ISO 11737-2.
8.6 The biological safety of product following exposure to the sterilization process shall be established in
accordance with ISO 10993-1.
8.7 A health-based risk assessment shall be conducted in accordance with ISO 10993-17 to identify and
document limits for process residuals in product.
ISO 14937:2000(E)
8.8 If necessary, means shall be established to reduce level(s) of process residual(s) in product below that
(those) identified in accordance with 8.7.
8.9 It shall be demonstrated that the product meets its specified requirements for safety, quality and performance
following application of the specified sterilization process.
8.10 The specification for the sterilization process shall be documented.
9 Validation
9.1 General
The purpose of validation is to demonstrate that the sterilization process established in process definition (see
clause 8) can be delivered effectively and reproducibly to the sterilization load. Validation consists of a number of
identified stages: installation qualification, operational qualification and performance qualification.
Installation qualification is undertaken to demonstrate that the sterilization equipment and any ancillary items have
been supplied and installed in accordance with their specification.
Operational qualification is carried out either with unloaded equipment or using appropriate test material to
demonstrate the capability of the equipment to deliver the sterilization process that has been defined (see
clause 8).
Performance qualification is the stage of validation that uses product to demonstrate that equipment consistently
operates in accordance with predetermined criteria and the process produces product that is sterile and meets the
specified requirements.
9.2 Installation qualification
9.2.1 Equipment
9.2.1.1 The c
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