prEN ISO 17665
(Main)Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 17665:2022)
Dieses Dokument enthält Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung von Verfahren für die Sterilisation von Medizinprodukten durch feuchte Hitze. Die Norm enthält außerdem Leitfäden, die die in den normativen Abschnitten dargelegten Anforderungen erläutern sollen. Die vorgelegten Leitfäden sind dafür vorgesehen, bewährte Praktiken in Bezug auf Sterilisationsverfahren mit feuchter Hitze, die diesem Dokument entsprechen, zu unterstützen. Die Anwendung in industriellen Umgebungen und in Einrichtungen der Gesundheitsfürsorge wird berücksichtigt.
1.1 Im Anwendungsbereich enthalten
1.1.1 Zu den durch dieses Dokument erfassten Sterilisationsverfahren mit feuchter Hitze gehören, ohne darauf begrenzt zu sein:
a) Sterilisation mit gesättigtem Dampf, bei der Luft durch Dampf verdrängt wird;
b) Sterilisation mit gesättigtem Dampf, bei der Luft durch aktive Entlüftung (Zwangsentlüftung) entfernt wird;
c) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Dampf-Luft-Gemische erreicht wird;
d) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Wasserberieselung erreicht wird;
e) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Eintauchen in Wasser erreicht wird.
ANMERKUNG 1 Siehe Anhang D, in dem die Verfahren eingehender erläutert werden.
ANMERKUNG 2 Obgleich der Anwendungsbereich dieses Dokuments auf Medizinprodukte begrenzt ist, legt es Anforderungen fest und gibt Anleitungen, die auf weitere Produkte für die Gesundheitsfürsorge und industrielle Anwendungen anwendbar sein können.
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/DIS 17665:2022)
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO/DIS 17665:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 17665:2022
01-november-2022
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 17665:2022)
Sterilization of health care products - Moist heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO/DIS
17665:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 17665:2022)
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/DIS 17665:2022)
Ta slovenski standard je istoveten z: prEN ISO 17665
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 17665:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 17665:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 17665:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17665
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-01 2022-11-24
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 17665:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
---------------------- Page: 3 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17665
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 17665:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
---------------------- Page: 4 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(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 .12
5 Sterilizing agent characterization .13
5.1 Sterilizing agent . 13
5.2 Microbicidal effectiveness . .13
5.3 Effects on materials . 13
5.4 Environmental consideration .13
6 Process and equipment characterization .14
6.1 General . 14
6.2 Process characterization . 14
6.3 Saturated steam sterilization processes . 15
6.4 Contained product sterilization processes . 16
6.5 Equipment . 16
7 Product definition .18
8 Process definition .19
9 Validation . .21
9.1 General . 21
9.2 Installation qualification (IQ) . 22
9.3 Operational qualification (OQ) . 23
9.4 Performance qualification (PQ) . 23
9.5 Review and approval of validation . 25
10 Routine monitoring and control.25
10.1 Routine monitoring . 25
10.2 Operational status . 25
10.3 Process success verification .26
10.4 Evaluation of additional data for saturated steam sterilization processes .26
10.5 Evaluation of additional data for sterilization processes for contained product . 27
10.6 Record retention . 27
11 Product release from sterilization .27
12 Maintaining process effectiveness .27
12.1 Purpose . 27
12.2 Demonstration of continued effectiveness . 27
12.3 Recalibration .28
12.4 Equipment maintenance .28
12.5 Requalification .28
12.6 Assessment of change . 29
Annex A (informative) Guidance on the principles of moist heat sterilization and rationales
for requirements .30
Annex B (informative) Establishment and evaluation of a sterilization process primarily
based on microbiological inactivation .59
Annex C (informative) Establishing a sterilization process primarily based on the
measurement of physical parameters .72
iii
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
Annex D (informative) Operating cycles .81
Annex E (informative) Temperature and pressure of saturated steam for use in moist heat
sterilization .87
Annex F (informative) Guidance on the application of normative requirements in health
care facility settings .92
Annex G (informative) Guidance on the designation of a medical device to a product family
and processing category for sterilization by moist heat .116
Annex H (informative) Guidance on the application of the normative requirements in the
industrial setting . 123
Bibliography . 148
iv
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces ISO 17665-1, ISO/TS 17665-2 and ISO/TS 17665-3, which have
been technically revised and merged into a single document.
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.html.
v
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(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, 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 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 so in practice saturated steam is not used in production steam sterilizers. Mixtures of steam
and non-condensable gases, albeit in very low levels, will be supplied to the sterilizer and employed as
the sterilizing agent, moist heat.
ISO 17665 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 incoming raw materials and/or components;
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;
vi
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(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 17664-1) be regarded as special cases. 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 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 supported by appropriate normative Annexes. 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 may 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. While
the activities required by this document have been grouped together and are presented in a particular
order, the 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 may be iterative. It is possible that performing these different activities will involve a number
of separate individuals and/or organizations, 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 standard 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, such as 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.
vii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
oSIST prEN ISO 17665:2022
---------------------- Page: 10 ----------------------
oSIST prEN ISO 17665:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 17665:2022(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 standard 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
1.1.1 Moist heat sterilization processes covered by this document include but are not limited to:
a) Saturated steam sterilization in which air is removed by venting;
b) Saturated steam sterilization in which air is removed by active air removal;
c) Contained product sterilization in which heat transfer is achieved by 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 See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
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 Attention is drawn to national or regional requirements for designating 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 could be applicable national or regional regulations for operational safety.
1
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
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, S
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.