ISO/FDIS 17665

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Stérilisation des produits de santé — Chaleur humide — Exigences pour le développement, la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs médicaux

General Information

• Status: Not Published
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198/WG 3 - Moist heat sterilization
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 07-Sep-2023
• Completion Date: 07-Sep-2023

Relations

• Revises: ISO/TS 17665-3:2013 - Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
• Effective Date: 23-Apr-2020
• Revises: ISO 17665-1:2006 - Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• Effective Date: 23-Apr-2020
• Revises: ISO/TS 17665-2:2009 - Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
• Effective Date: 23-Apr-2020

Standards Content (Sample)

ISO/FDIS 17665:2023(E)
2023-04-28
ISO/TC 198/WG 3
Secretariat: AAMI (for ANSI)
Date: 2023-07-17
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine control
of a sterilization process for medical devices
Stérilisation des produits de santé — Chaleur humide — Exigences pour le développement, la validation et
le contrôle de routine d’un procédé de stérilisation des dispositifs médicaux
FDIS stage

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ISO/FDIS 17665:2023(E)
© ISO 2023
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ISO/FDIS 17665:2023(E)


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ISO/FDIS 17665:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documentsdocument should be noted. This document was drafted in accordance
with the editorial rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directiveswww.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of
this document, ISO had not received notice of (a) patent(s) which may be required to implement this
document. However, implementers are cautioned that this may not represent the latest information,
which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held
responsible for identifying any or all such patent rights. Details of any patent rights identified during the
development of the document will be in the Introduction and/or on the ISO list of patent declarations
received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC
204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (of ISO 17665-1), as well as:2006, ISO/TS
17665-2:2009 and ISO/TS 17665-3:2013, which have been technically revised.
The main changes compared to the previous editions are as follows:
— — combined ISO 17665-1, ISO/TS 17665-2 and ISO/TS 17665-3 into a single standard.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at
www.iso.org/members.htmlwww.iso.org/members.html.
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ISO/FDIS 17665:2023(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, couldcan, 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 can 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 ensured and the expression of sterility of a processed population is defined in terms
of the probability of there being a viable microorganism present on a product item.
The process variables for a moist heat sterilization process, i.e. those which contribute towards microbial
lethality, are exposure to adequate temperature for a prerequisite time in the presence of moisture. Moist
heat sterilization can be utilised as a saturated steam process, where saturated steam is allowed to
directly contact all surfaces to be sterilized, or as a contained product sterilization process, where steam,
steam mixed with air or other gas, or hot water under pressure are used as the heating medium in order
to generate moist heat within the sealed contained product. The term saturated steam describes a
theoretical state in which water and vapour are in equilibrium and that no other gases are present. In
practice theoretical saturated steam state conditions are not achieved. Mixtures of steam and non-
condensable gasesNCGs, albeit in very low levels, will be supplied to the sterilizer and employed as the
sterilizing agent, moist heat.
ISO 17665This document describes requirements that, if met, will provide a moist heat sterilization
process intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,
conformance with the requirements, ensures this activity 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 product after every sterilization process is complete. 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, monitored and recorded 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 factors including:
a) a) the microbiological status of either incoming raw materials and/or components, or both;
b) b) the validation and routine control of any cleaning and disinfection procedures used on the
product;
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ISO/FDIS 17665:2023(E)
c) c) the control of the environment in which the product is manufactured, assembled and packaged;
d) d) the control of equipment and processes;
e) e) the control of personnel and their hygiene;
f) f) the manner and materials in which the product is packaged;
g) g) the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this has an impact upon the
effectiveness of a sterilization process. It is preferable that products that have been used in a health care
setting and that are being presented for sterilization in accordance with the instructions for use (see ISO
17664-1) be regarded as special cases. There is the potential for such products to possess a wide range
of contaminating microorganisms (bioburden) and either residual inorganic and/or organic
contamination, or both, 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 processing. The
ISO 15883 series provides requirements for and information on automated cleaning and disinfection
processes.
This document describes the requirements for ensuring that the activities associated with the process of
moist heat sterilization are performed properly. The requirements are the normative parts of this
document with which conformance is claimed. The guidance given in the informative Annexes is not
intended as checklists for assessing conformance with the requirements of this document. The guidance
in the informative Annexes is intended to assist in obtaining a uniform understanding and
implementation of the requirements in this document by providing explanations, rationales, examples
and methods that are regarded as being suitable means for conforming with the requirements. Methods
other than those given in the guidance can be used if they are effective in achieving conformance with the
requirements of this document.
The development, validation and routine control of a sterilization process comprise a number of discrete
but interrelated activities, e.g. calibration, equipment maintenance, product definition, process definition,
installation qualification, operational qualification and performance qualification (IQ), OQ and PQ, during
which, along with other characteristics, compatibility of product and materials will be ascertained. . While
the activities required by this document have been grouped together and are presented in a particular
order, the standardthis document 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. It is possible that performing these different activities will involve a
number of either separate individuals and/or organizations, or both, each of whom undertake one or
more of these activities. This document does not specify the particular individuals or organizations who
are responsible for carrying out the activities.
The requirements of this document are applicable to all settings where moist heat sterilization of medical
devices is carried out. However, this standarddocument or part of it can be applied to the moist heat
sterilization of other products.
Medical devices processed in an industrial setting can, in certain circumstances, be manufactured using
standardised processes that result in product with a known and controlled bioburden prior to
sterilization. Medical devices processed, in health care facilities can include a wide variety of product with
varying levels of bioburden. Appropriate and thorough cleaning and, where necessary for safe handling,
decontamination processes, are used prior to presenting product for sterilization. Mixed product loads
are common in facilities reprocessing medical devices with throughput volumes dictated by historical
and predicted demand for sterile product.
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ISO/FDIS 17665:2023(E)
Annex AAnnex A provides guidance on the principles of moist heat sterilization and provides a rationale
for the requirements. Specific guidance for health care facilities is given in Annex FAnnex F and for
industrial applications, in Annex H.Annex H. The numbering and structure of the clauses in
Annex FAnnex F and Annex HAnnex H correspond to the numbering and structure of the clauses in the
normative requirements section of this document.
An overview of the purpose of each normative section is provided at the beginning of Clauses 5Clauses 5
to 1212 (see ISO 14937). Table A.1Table A.1 summarises the purpose of each normative section and
suggests the roles and responsibilities for the organisations and personnel involved in each element of
the development, validation and routine control of a moist heat sterilization process and moist heat
sterilizer.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 17665:2023(E)

Sterilization of health care products — Moist heat — Requirements
for the development, validation and routine control of a
sterilization process for medical devices
1 Scope
This document provides requirements for the development, validation and routine control of moist heat
sterilization processes for medical devices. The standardIt also contains guidance which is intended to
explain the requirements set forth in the normative sections. The guidance given is intended to promote
good practice related to moist heat sterilization processes according to this document. The application
within industrial and health care settings is considered.
1.1 Inclusions
Moist heat sterilization processes covered by this document include, but are not limited to:
a) a) saturated steam sterilization in which air is removed by passive purging (gravity displacement
principle);
b) b) saturated steam sterilization in which air is removed by active air removal (dynamic air removal,
pre-vacuum/fractionated vacuum principle);
c) c) contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;
d) d) contained product sterilization in which heat transfer is achieved by water sprays;
e) e) contained product sterilization in which heat transfer is achieved by water immersion.
NOTE 1 See Annex DAnnex D where the processes are explained further.
NOTE 2 Although the scope of this document is limited to medical devices, it specifies requirements and provides
guidance that can be applicable to other health care products and industrial applications.
1.2 Exclusions
1.2.1 This document does not specify requirements 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.
NOTE 1 See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
NOTE 2 Specific regulations have been produced in particular countries for the processing of materials
potentially contaminated with these agents.
1.2.2 This document does not apply to those sterilization processes that are based on a combination of
moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
1.2.3 This document does not detail a specified requirement for designating a medical device as
“sterile.”
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ISO/FDIS 17665:2023(E)
NOTE Attention is drawn to National or regional requirements for designatingcan designate medical devices
as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.4 This document does not specify requirements for occupational safety associated with the design
and operation of moist heat sterilization facilities.
NOTE There can be applicable national or regional regulations for operational safety.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11138--1:2017, Sterilization of health care products — Biological indicators — Part 1: General
requirements
ISO 11138--3:2017, Sterilization of health care products — Biological indicators — Part 3: Biological
indicators for moist heat sterilization processes
ISO 11140-1,11140all parts), Sterilization of health care products — Chemical indicators — Part 1: General
requirements
ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator
systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an
alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for
Bowie and Dick-type air removal tests
ISO 11140-6, Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and
process challenge devices for use in performance testing of small steam sterilizers.
ISO 11607--1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607--2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 11737--1, Sterilization of health care products — Microbiological methods — Part 1: Determination of
a population of microorganisms on products
ISO 11737--2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp
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ISO/FDIS 17665:2023(E)
— — IEC Electropedia: available at https://www.electropedia.org/https://www.electropedia.org/
3.1
air detector
device designed to detect the presence of non-condensable gases in the chamber or in a stream of steam
and condensate
[SOURCE: ISO 11139:2018, 3.9]
3.2
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to
programmed cycle parameters
[SOURCE: ISO 11139:2018, 3.18]
3.3
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
Note 1 to entry: For the purposes of this document the term biological indicator may be abbreviated to BI.
[SOURCE: ISO 11139:2018, 3.29, modified – Note 1 to entry added]
3.5
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by the measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
[SOURCE: ISO 11139:2018, 3.31]
3.6
chamber
part of equipment in which a load is processed
Note 1 to entry: For the purposes of this document the chamber is the sterilizer chamber
[SOURCE: ISO 11139:2018, 3.36, modified – Note 1 to entry added]
3.7
chemical indicator
test system that reveals change in one or more pre-specified process variables based on a chemical or
physical change resulting from exposure to a process
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ISO/FDIS 17665:2023(E)
Note 1 to entry: For the purposes of this document the term chemical indicator may be abbreviated to CI.
[SOURCE: ISO 11139:2018, 3.43, modified – Note 1 to entry added]
3.8
conditioning
treatment of product prior to the exposure phasestage to attain a specified temperature, relative
humidity, or other process variable throughout the load
[SOURCE: ISO 11139:2018, 3.58]
3.9
contained product
load for which the ambient media within a chamber do not come into direct contact with the item to be
processed
Note 1 to entry: The environment within the sterilizer is used for heating and cooling purposes only, not for
achieving the sterilization effect;, e.g. a solution in a sealed bottle.
3.10
contained product sterilization
validated process where indirect contact of a heating medium on the external surfaces of contained
product is used to create moist heat internally to achieve the specified requirements for sterility within
the contained product
Note 1 to entry: The environment within the sterilizer is used for heating and cooling purposes only, not for
achieving the sterilization effect;, e.g. a solution in a sealed bottle.
1
[SOURCE: ISO 11139:2018 & Amd1:20— , 3.332, modified –— Note 1 to entry added].]
3.11
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action.
[SOURCE: ISO 11139:2018, 3.64]
3.12
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
[SOURCE: ISO 11139:2018, 3.65]

1
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ISO/FDIS 17665:2023(E)
3.13
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication, and recording of
an operating cycle
[SOURCE: ISO 11139:2018, 3.72]
3.14
cycle variable
property used to control, monitor, indicate, or record an operating cycle
[SOURCE: ISO 11139:2018, 3.74]
3.15
D value
D value
10
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test
microorganisms
Note 1 to entry: For the purposes of this document, D value refers to the exposure period necessary to achieve 90 %
reduction.
Note 2 to entry: The definition of D value assumes that a plot of log10 of population versus time of exposure is linear
within accepted tolerances.
[SOURCE: ISO 11139:2018, 3.75, modified — Notes to entry have been added].]
3.16
development
act of elaborating a specification
[SOURCE: ISO 11139:2018, 3.79]
3.17
equilibration time
period between the attainment of defined sterilization process parameters at the reference measurement
point and the attainment of the specified sterilization process parameters at all points within the load
Note 1 to entry: For the purposes of this document the process parameter to which this definition refers is
temperature.
Note 2 to entry: Equilibration time is also known as sterilization time lag.
[SOURCE: ISO 11139:2018, 3.105, modified — Notes to entry have been added].]
3.18
equipment maintenance
combination of all technical and associated administrative actions intended to keep equipment at a state
in which it can perform its required function, or restore it to such a state
[SOURCE: ISO 11139:2018, 3.106]
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ISO/FDIS 17665:2023(E)
3.19
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO 11139:2018, 3.107]
3.20
evaluation
systematic and objective comparison of the measured results either with one another or with a
specification to be met in initial, intermediate and final tests
Note 1 to entry: Evaluation analyses the level of achievement of both expected and unexpected results by examining
the results chain, processes, contextual factors and causality using appropriate criteria. An evaluation provides
credible, useful evidence-based information that enables the timely incorporation of its findings, recommendations
and lessons into the decision-making processes of organizations and stakeholders.
[SOURCE: ISO 9022-1:2016, 2.10, modified –— added "systematic and objective" at the beginning of the
definition and Note 1 to entry has been added].]
3.21
exposure stage
cycle stage between the introduction of the sterilizing or disinfecting agent into the chamber and when
the agent is removed or neutralised
Note 1 to entry: For the purposes of this document the exposure stage only includes that part of the process for
which microbial lethality is claimed.
2
[SOURCE: ISO 11139:2018 & Amd 1:20— , 3.111, modified – Note 1 to entry has been added]
3.22
Fo value
measure of microbiological lethality delivered by a moist heat sterilization process expressed in terms of
the equivalent time, in minutes, at a temperature of 121,1 °C with reference to microorganisms with a z
value of 10 ℃°C
[SOURCE: ISO 11139:2018, 3.113.1, modified – 10 K was replaced by °C (by convention, z value is
expressed in ℃]°C).]
3.23
FBIO value
expression of the resistance of a biological indicator calculated as the product of the logarithm to base 10
of the initial population of microorganisms and the D value

Note 1 to entry: For the purposes of this document the term FBIO is also known as the BI microbiological challenge.

[SOURCE: ISO 11139:2018, 3.113.2, modified – Note 1 "to entrybase 10" added to the definition]

2
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ISO/FDIS 17665:2023(E)
3.24
FBIOLOGICAL value
expression of the delivered lethality of a process, measured in terms of actual kill of microorganisms on
or in a BIbiological indicator challenge system
Note 1 to entry: FBIOLOGICAL can be calculated by multiplying the D121 value by the difference between the log to the
base ten of the starting population and the log to the base ten of the enumerated population after processing.
3.25
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: ISO 11139:2018, 3.116]
3.26
health care facility
HCF
dedicated setting where health care professionals deliver services for care of patients
EXAMPLE Hospitals, free standing ambulatory surgical centres, nursing homes, extended care facilities,
medical, dental and physician offices or clinics and other specialized treatment facilities.
3
[SOURCE: ISO 11139:2018 & Amd 1:20— ,3.339]
3.27
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including
biopharmaceutical
[SOURCE: ISO 11139:2018, 3.132]
3.28
holding time
period for which the temperatures at the reference measurement point and all
points within the load are continuously within the sterilization temperature band
4
[SOURCE: ISO 11139:2018 & Amd 1:20— , 3.133.1]
3.29
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]

3
 Under preparation: Stage at time of publication: ISO 11139:2018/DAmd 1
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17665
ISO/TC 198
Sterilization of health care products —
Secretariat: ANSI
Moist heat — Requirements for the
Voting begins on:
2023-09-07 development, validation and routine
control of a sterilization process for
Voting terminates on:
2023-11-02
medical devices
Stérilisation des produits de santé — Chaleur humide — Exigences
pour le développement, la validation et le contrôle de routine d’un
procédé de stérilisation des dispositifs médicaux
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 17665:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

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ISO/FDIS 17665:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17665
ISO/TC 198
Sterilization of health care products —
Secretariat: ANSI
Moist heat — Requirements for the
Voting begins on:
development, validation and routine
control of a sterilization process for
Voting terminates on:
medical devices
Stérilisation des produits de santé — Chaleur humide — Exigences
pour le développement, la validation et le contrôle de routine d’un
procédé de stérilisation des dispositifs médicaux
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ISO/FDIS 17665:2023(E)
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ISO/FDIS 17665:2023(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 General .13
5 Sterilizing agent characterization .14
5.1 Sterilizing agent . 14
5.2 Microbicidal effectiveness . . 14
5.3 Effects on materials . 14
5.4 Environmental consideration . 14
6 Process and equipment characterization .15
6.1 General . 15
6.2 Process characterization .15
6.3 Saturated steam sterilization processes . 16
6.4 Contained product sterilization processes . 17
6.5 Equipment . 17
7 Product definition .19
8 Process definition .21
9 Validation . .23
9.1 General .23
9.2 Installation qualification (IQ) . 24
9.3 Operational qualification (OQ) . 24
9.4 Performance qualification (PQ) . 25
9.5 Review and approval of validation . 27
10 Routine monitoring and control.27
10.1 Routine monitoring . 27
10.2 Operational status . 27
10.3 Process verification .28
10.4 Evaluation of additional data for saturated steam sterilization processes .28
10.5 Evaluation of additional data for contained product sterilization processes. .29
10.6 Record retention .29
11 Product release from sterilization .29
12 Maintaining process effectiveness .29
12.1 Purpose .29
12.2 Demonstration of continued effectiveness .30
12.3 Recalibration .30
12.4 Equipment maintenance .30
12.5 Requalification . 31
12.6 Assessment of change . 31
Annex A (informative) Guidance on the principles of moist heat sterilization and rationales
for requirements .32
Annex B (informative) Establishment and evaluation of a sterilization process primarily
based on microbiological inactivation .61
Annex C (informative) Establishment and evaluation of a sterilization process primarily
based on the measurement of physical parameters .75
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ISO/FDIS 17665:2023(E)
Annex D (informative) Examples of moist heat sterilization cycles .85
Annex E (informative) Temperature and pressure of saturated steam for use in moist heat
sterilization .91
Annex F (informative) Guidance on the application of the normative requirements in
health care facilities . .95
Annex G (informative) Guidance on the designation of a medical device to a product family
and processing category for sterilization by moist heat . 120
Annex H (informative) Guidance on the application of the normative requirements in
industrial settings . 128
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 153
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered . 157
Bibliography . 160
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ISO/FDIS 17665:2023(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 non­governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition of ISO 17665-1:2006, ISO/TS 17665-2:2009
and ISO/TS 17665-3:2013, which have been technically revised.
The main changes compared to the previous editions are as follows:
— combined ISO 17665­1, ISO/TS 17665­2 and ISO/TS 17665­3 into a single standard.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/FDIS 17665:2023(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, can, prior to sterilization, have microorganisms on them, albeit
in low numbers. Such medical devices are non­sterile. 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 can 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 ensured and the expression of sterility of a processed population is defined in
terms of the probability of there being a viable microorganism present on a product item.
The process variables for a moist heat sterilization process, i.e. those which contribute towards
microbial lethality, are exposure to adequate temperature for a prerequisite time in the presence of
moisture. Moist heat sterilization can be utilised as a saturated steam process, where saturated steam
is allowed to directly contact all surfaces to be sterilized, or as a contained product sterilization process,
where steam, steam mixed with air or other gas, or hot water under pressure are used as the heating
medium in order to generate moist heat within the sealed contained product. The term saturated steam
describes a theoretical state in which water and vapour are in equilibrium and that no other gases are
present. In practice theoretical saturated steam state conditions are not achieved. Mixtures of steam
and NCGs, albeit in very low levels, will be supplied to the sterilizer and employed as the sterilizing
agent, moist heat.
This document describes requirements that, if met, will provide a moist heat sterilization process
intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,
conformance with the requirements, ensures this activity 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 product after every sterilization process is complete.
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, monitored and recorded 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 factors including:
a) the microbiological status of either incoming raw materials or components, or both;
b) the validation and routine control of any cleaning and disinfection procedures used on the product;
c) the control of the environment in which the product is manufactured, assembled and packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
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ISO/FDIS 17665:2023(E)
f) the manner and materials in which the product is packaged;
g) the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this has an impact upon the
effectiveness of a sterilization process. It is preferable that products that have been used in a health
care setting and that are being presented for sterilization in accordance with the instructions for use
(see ISO 17664­1) be regarded as special cases. There is the potential for such products to possess a
wide range of contaminating microorganisms (bioburden) and either residual inorganic or organic
contamination, or both, 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 processing.
The ISO 15883 series provides requirements for and information on automated cleaning and
disinfection processes.
This document describes the requirements for ensuring that the activities associated with the process
of moist heat sterilization are performed properly. The requirements are the normative parts of this
document with which conformance is claimed. The guidance given in the informative Annexes is
not intended as checklists for assessing conformance with the requirements of this document. The
guidance in the informative Annexes is intended to assist in obtaining a uniform understanding and
implementation of the requirements in this document by providing explanations, rationales, examples
and methods that are regarded as being suitable means for conforming with the requirements. Methods
other than those given in the guidance can be used if they are effective in achieving conformance with
the requirements of this document.
The development, validation and routine control of a sterilization process comprise a number of
discrete but interrelated activities, e.g. calibration, equipment maintenance, product definition, process
definition, installation qualification (IQ), OQ and PQ, during which, along with other characteristics,
compatibility of product and materials will be ascertained. While the activities required by this
document have been grouped together and are presented in a particular order, this document 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. It is
possible that performing these different activities will involve a number of either separate individuals
or organizations, or both, each of whom undertake one or more of these activities. This document
does not specify the particular individuals or organizations who are responsible for carrying out the
activities.
The requirements of this document are applicable to all settings where moist heat sterilization of
medical devices is carried out. However, this document or part of it can be applied to the moist heat
sterilization of other products.
Medical devices processed in an industrial setting can, in certain circumstances, be manufactured
using standardised processes that result in product with a known and controlled bioburden prior to
sterilization. Medical devices processed in health care facilities can include a wide variety of product
with varying levels of bioburden. Appropriate and thorough cleaning and, where necessary for safe
handling, decontamination processes, are used prior to presenting product for sterilization. Mixed
product loads are common in facilities reprocessing medical devices with throughput volumes dictated
by historical and predicted demand for sterile product.
Annex A provides guidance on the principles of moist heat sterilization and provides a rationale for
the requirements. Specific guidance for health care facilities is given in Annex F and for industrial
applications, in Annex H. The numbering and structure of the clauses in Annex F and Annex H
correspond to the numbering and structure of the clauses in the normative requirements section of this
document.
An overview of the purpose of each normative section is provided at the beginning of Clauses 5 to 12
(see ISO 14937). Table A.1 summarises the purpose of each normative section and suggests the roles
and responsibilities for the organisations and personnel involved in each element of the development,
validation and routine control of a moist heat sterilization process and moist heat sterilizer.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 17665:2023(E)
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
This document provides requirements for the development, validation and routine control of moist
heat sterilization processes for medical devices. It also contains guidance which is intended to explain
the requirements set forth in the normative sections. The guidance given is intended to promote good
practice related to moist heat sterilization processes according to this document. The application
within industrial and health care settings is considered.
1.1 Inclusions
Moist heat sterilization processes covered by this document include, but are not limited to:
a) saturated steam sterilization in which air is removed by passive purging (gravity displacement
principle);
b) saturated steam sterilization in which air is removed by active air removal (dynamic air removal,
pre-vacuum/fractionated vacuum principle);
c) contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;
d) contained product sterilization in which heat transfer is achieved by water sprays;
e) contained product sterilization in which heat transfer is achieved by water immersion.
NOTE 1 See Annex D where the processes are explained further.
NOTE 2 Although the scope of this document is limited to medical devices, it specifies requirements and
provides guidance that can be applicable to other health care products and industrial applications.
1.2 Exclusions
1.2.1 This document does not specify requirements 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.
NOTE 1 See ISO 22442­1, ISO 22442­2 and ISO 22442­3.
NOTE 2 Specific regulations have been produced in particular countries for the processing of materials
potentially contaminated with these agents.
1.2.2 This document does not apply to those sterilization processes that are based on a combination
of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
1.2.3 This document does not detail a specified requirement for designating a medical device as
“sterile.”
NOTE National or regional requirements can designate medical devices as “sterile.” See, for example,
EN 556­1 or ANSI/AAMI ST67.
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ISO/FDIS 17665:2023(E)
1.2.4 This document does not specify requirements for occupational safety associated with the
design and operation of moist heat sterilization facilities.
NOTE There can be applicable national or regional regulations for operational safety.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references,
...