EN ISO 17665:2024
(Main)Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
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.
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 17665:2024)
Dieses Dokument enthält Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung von Verfahren für die Sterilisation von Medizinprodukten durch feuchte Hitze. Es 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 des Gesundheitswesens wird berücksichtigt.
1.1 Im Anwendungsbereich enthalten
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 passives Ausspülen verdrängt wird (Prinzip der Verdrängung durch die Schwerkraft);
b) Sterilisation mit gesättigtem Dampf, bei der Luft durch aktive Entlüftung entfernt wird (dynamische Entlüftung, Prinzip des Vorvakuums/fraktionierten Vakuums);
c) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Dampf oder 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, schreibt es Anforderungen fest und gibt Anleitungen, die auf weitere Produkte für die Gesundheitsfürsorge und industrielle Anwendungen anwendbar sein können.
1.2 Im Anwendungsbereich nicht enthalten
1.2.1 Dieses Dokument legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens zur Inaktivierung der Erreger fest, die spongiforme Enzephalopathien wie Scrapie, bovine spongiforme Enzephalitis und Creutzfeldt-Jakob-Krankheit auslösen.
ANMERKUNG 1 Siehe auch ISO 22442 1, ISO 22442 2 und ISO 22442 3.
ANMERKUNG 2 In bestimmten Ländern wurden spezifische Bestimmungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet.
1.2.2 Dieses Dokument ist nicht anwendbar für diejenigen Sterilisationsverfahren, deren Grundlage eine Kombination von feuchter Hitze mit anderen biologisch abtötenden Mitteln (z. B. Formaldehyd) als sterilisierendes Agens ist.
1.2.3 Dieses Dokument legt keine im Einzelnen festgeschriebenen Anforderung zur Bezeichnung eines Medizinprodukts als „steril“ fest.
ANMERKUNG Nationale oder regionale Anforderungen können Medizinprodukte als „steril“ kennzeichnen. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
1.2.4 Dieses Dokument legt keine Anforderungen für die Arbeitssicherheit fest, die mit der Gestaltung und dem Betrieb von Einrichtungen zur Sterilisation mit feuchter Hitze zusammenhängen.
ANMERKUNG Es könnten nationale oder regionale Bestimmungen für die Betriebssicherheit anwendbar sein.
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 17665:2024)
Le présent document spécifie les exigences relatives au développement, à la validation et au contrôle de routine des procédés de stérilisation des dispositifs médicaux à la chaleur humide. Il contient également des recommandations destinées à expliquer les exigences spécifiées dans les sections normatives. Les recommandations fournies sont destinées à promouvoir les bonnes pratiques relatives aux procédés de stérilisation à la chaleur humide conformément au présent document. Les applications dans les installations industrielles et les établissements de soins de santé sont prises en considération.
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 17665:2024)
Ta dokument podaja zahteve za razvoj, validacijo in rutinsko kontrolo postopkov sterilizacije z vlažno toploto za medicinske pripomočke. Vsebuje tudi smernice, ki pojasnjujejo zahteve, določene v normativnih razdelkih. Podane smernice so namenjene spodbujanju dobre prakse v zvezi s postopki sterilizacije z vlažno toploto v skladu s tem dokumentom. Pri tem je upoštevana uporaba v industrijske in zdravstvene namene.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO 17665:2024)
Sterilization of health care products - Moist heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO
17665:2024)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 17665:2024)
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 17665:2024)
Ta slovenski standard je istoveten z: EN ISO 17665:2024
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.
EN ISO 17665
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17665-1:2006, CEN ISO/TS 17665-
2:2009
English Version
Sterilization of health care products - Moist heat -
Requirements for the development, validation and routine
control of a sterilization process for medical devices (ISO
17665:2024)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die
Exigences pour le développement, la validation et le Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
contrôle de routine d'un procédé de stérilisation des an die Entwicklung, Validierung und Lenkung der
dispositifs médicaux (ISO 17665:2024) Anwendung eines Sterilisationsverfahrens für
Medizinprodukte (ISO 17665:2024)
This European Standard was approved by CEN on 3 December 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17665:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 9
European foreword
This document (EN ISO 17665:2024) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2024, and conflicting national standards
shall be withdrawn at the latest by November 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17665-1:2006 and CEN ISO/TS 17665-2:2009.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA or ZB, which is an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 17665:2024 has been approved by CEN as EN ISO 17665:2024 without any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail. In this context, the definition of ‘medical device’ in this standard is a modified
version of the definition prepared by the Global Harmonization Task Force with modification to the
Note in the definition.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — – Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/745
11.3 4,5,6,7,8,9,10,11,12 This standard provides requirements for
the development, validation and routine
control of a sterilization process using
moist heat for medical devices, including
requirements that the medical device is
safe and performs as intended after
treatment. It could also be applied to the
development, validation and routine
control of a process for attainment of a
specific microbial state other than sterility.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which treatment by moist
heat is appropriate.
This relevant General Safety and
Performance Requirement is only partly
addressed in this European Standard.
Design and packaging for maintenance of a
specific microbial state during
transportation and storage are not covered.
Aspects of manufacture other than those
related to attainment of a specific microbial
state using moist heat are not covered.
11.4 first sentence only 4,5,6,7,8,9,10,11,12 This standard provides requirements for
the development, validation and routine
control of a sterilization process using
moist heat for medical devices, including
requirements that the sterilized medical
device is safe and performs as intended
after sterilization. This General Safety and
Performance Requirement is addressed
only with regard to devices for which
sterilization by moist heat is appropriate.
This relevant General Safety and
Performance Requirement is only partly
addressed in this European Standard.
Design and packaging for maintenance of
sterility during transportation and storage
are not covered. Aspects of manufacture
other than those related to attainment of
sterility by moist heat are not covered.
Evidence that the integrity of the packaging
General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/745
is maintained to the point of use is not
covered.
11.5 4,5,6,7,8,9,10,11,12 This standard provides requirements for
the development, validation and routine
control of a sterilization process using
moist heat for medical devices, including
requirements that the sterilized medical
device is safe and performs as intended
after sterilization. This General Safety and
Performance Requirement is addressed
only with regard to devices for which
sterilization by moist heat is appropriate.
This relevant General Safety and
Performance Requirement is only partly
addressed in this European Standard.
Packaging for maintenance of sterility is
not covered. Aspects of manufacture other
than those related to attainment of sterility
using moist heat are not covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 11140-1 ISO 11140-1:2014 Sterilization of health care EN ISO 11140-1:2014
products — Chemical
indicators — Part 1:
General requirements
ISO 11140-3 ISO 11140-3:2007 Sterilization of health care EN ISO 11140-3:2009
products — Chemical
indicators — Part 3: Class 2
indicator systems for use in
the Bowie and Dick-type
steam penetration test
ISO 11140-4 ISO 11140-4:2007 Sterilization of health care EN ISO 11140-4:2007
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 ISO 11140-5:2007 Sterilization of health care None
products — Chemical
For applicable standard edition
indicators — Part 5: Class 2
see Column 2
indicators for Bowie and
Dick-type air removal tests
ISO 11140-6 ISO 11140-6:2022 Sterilization of health care EN ISO 11140-6:2022
products — Chemical
indicators — Part 6: Type 2
indicators and process
challenge devices for use in
performance testing of
small steam sterilizers.
ISO 11607-1 ISO 11607-1:2019 Packaging for terminally EN ISO 11607-
sterilized medical devices 1:2020+A11:2022
— Part 1: Requirements for
materials, sterile barrier
systems and packaging
systems
ISO 11607-2 ISO 11607-2:2019 Packaging for terminally EN ISO 11607-
sterilized medical devices 2:2020+A11:2022
— Part 2: Validation
requirements for forming,
sealing and assembly
processes
ISO 11737-1 ISO 11737- Sterilization of health care EN ISO 11737-1:2018+A1:2021
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
1:2018/amd1:2021 products — Microbiological
methods — Part 1:
Determination of a
population of
microorganisms on
products
ISO 11737-2 ISO 11737-2:2019 Sterilization of health care EN ISO 11737-2:2020
products — Microbiological
methods — Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a
sterilization process
ISO 11138-1 ISO 11138-1:2017 Sterilization of health care EN ISO 11138-1:2017
products — Biological
indicators — Part 1:
General requirements
ISO 11138-3 ISO 11138-3:2017 Sterilization of health care EN ISO 11138-3:2017
products — Biological
indicators — Part 3:
Biological indicators for
moist heat sterilization
processes
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
Annex ZB
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZB.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/746, the differences shall be indicated in the Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/746, the definitions set out in this
Regulation prevail. In this context, the definition of ‘medical device’ in this standard is a modified
version of the definition prepared by the Global Harmonization Task Force with modification to the
Note in the definition.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the In vitro Diagnostic
Regulation (EU) 2017/746).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZB.1, it means that it is
not addressed by this European Standard.
Table ZB.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/746 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, performance
studies, clinical evidence or post-market performance follow-up.
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/746
11.2 4,5,6,7,8,9,10,11,12 This standard provides requirements
for the development, validation and
routine control of a sterilization
process using moist heat for medical
devices, including requirements that
the sterilized medical device is safe
and performs as intended after
sterilization. It could also be applied to
the development, validation and
routine control of a process for
attainment of a specific microbial state
other than sterility.
This General Safety and Performance
Requirement is addressed only with
regard to devices for which treatment
by moist heat is appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging for
maintenance of sterility or another
specific microbial state during
transportation and storage are not
covered. Aspects of manufacture other
than those related to attainment of
sterility or another specific microbial
state using moist heat are not covered.
11.3 4,5,6,7,8,9,10,11,12 This standard provides requirements
for the development, validation and
routine control of a sterilization
process using moist heat for medical
devices, including requirements that
the sterilized medical device is safe
and performs as intended after
sterilization. This General Safety and
Performance Requirement is
addressed only with regard to devices
for which sterilization by moist heat is
appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/746
Standard. Packaging for maintenance
of sterility is not covered. Aspects of
manufacture other than those related
to attainment of sterility using moist
heat are not covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 17665
First edition
Sterilization of health care
2024-03
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
Reference number
ISO 17665:2024(en) © ISO 2024
ISO 17665:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 17665:2024(en)
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 . .14
5.3 Effects on materials .14
5.4 Environmental consideration .14
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 .17
7 Product definition .18
8 Process definition .20
9 Validation . .22
9.1 General . 22
9.2 Installation qualification (IQ) . 23
9.3 Operational qualification (OQ) . 23
9.4 Performance qualification (PQ) .24
9.5 Review and approval of validation . 26
10 Routine monitoring and control.26
10.1 Routine monitoring . 26
10.2 Operational status . 26
10.3 Process verification .27
10.4 Evaluation of additional data for saturated steam sterilization processes .27
10.5 Evaluation of additional data for contained product sterilization processes. .27
10.6 Record retention . 28
11 Product release from sterilization .28
12 Maintaining process effectiveness .28
12.1 Purpose . 28
12.2 Demonstration of continued effectiveness . 28
12.3 Recalibration . 29
12.4 Equipment maintenance . 29
12.5 Requalification . 29
12.6 Assessment of change . 30
Annex A (informative) Guidance on the principles of moist heat sterilization and rationales for
requirements .31
Annex B (informative) Establishment and evaluation of a sterilization process primarily based
on microbiological inactivation .59
Annex C (informative) Establishment and evaluation of a sterilization process primarily based
on the measurement of physical parameters .73
iii
ISO 17665:2024(en)
Annex D (informative) Examples of moist heat sterilization cycles .83
Annex E (informative) Temperature and pressure of saturated steam for use in moist heat
sterilization .89
Annex F (informative) Guidance on the application of the normative requirements in health
care facilities .93
Annex G (informative) Guidance on the designation of a medical device to a product family and
processing category for sterilization by moist heat.118
Annex H (informative) Guidance on the application of the normative requirements in industrial
settings .126
Bibliography .150
iv
ISO 17665:2024(en)
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,
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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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)
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this may not represent the latest information, which may be obtained from the patent database available at
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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 first edition cancels and replaces 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 17665-1, ISO/TS 17665-2 and ISO/TS 17665-3 into a single standard.
A list of all parts in the ISO 17665 series can be found on the ISO website.
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 17665:2024(en)
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
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 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 17665:2024(en)
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 (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
docume
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