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
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
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.
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
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.
General Information
Relations
Buy Standard
Standards Content (Sample)
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
---------------------- Page: 1 ----------------------
ISO 17665:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
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 .
...
Norme
internationale
ISO 17665
Première édition
Stérilisation des produits de
2024-03
santé — Chaleur humide —
Exigences pour le développement, la
validation et le contrôle de routine
d’un procédé de stérilisation des
dispositifs médicaux
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine control
of a sterilization process for medical devices
Numéro de référence
ISO 17665:2024(fr) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 17665:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
© ISO 2024 – Tous droits réservés
ii
---------------------- Page: 2 ----------------------
ISO 17665:2024(fr)
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
1.1 Inclusions.1
1.2 Exclusions .1
2 Références normatives . 2
3 Termes et définitions . 2
4 Généralités .13
5 Caractérisation de l’agent stérilisant. 14
5.1 Agent stérilisant .14
5.2 Efficacité microbicide .14
5.3 Effets sur les matériaux .14
5.4 Considération environnementale . 15
6 Caractérisation du procédé et de l’équipement .15
6.1 Généralités . 15
6.2 Caractérisation du procédé . 15
6.3 Procédés de stérilisation à la vapeur saturée .16
6.4 Procédé de
...
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
---------------------- Page: 1 ----------------------
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
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 17665:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
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 .
...
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
---------------------- Page: 1 ----------------------
ISO/FDIS 17665:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 17665:2023(E)
© ISO 2023 – All rights reserved iii
© ISO 2023 – All rights reserved iii
---------------------- Page: 3 ----------------------
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.
iv © ISO 2023 – All rights reserved
iv © ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 17665:2023(E)
Introduction
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.