ISO 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: 6000 - International Standard under publication
• Completion Date: 03-Nov-2023

Relations

• 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
• 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

Standards Content (Sample)

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
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: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
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

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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 .
...

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
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: [phone]
EmailE-mail: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
ii © ISO 2023 – All rights reserved

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ISO/FDIS 17665:2023(E)


© ISO 2023 – All rights reserved iii
© ISO 2023 – All rights reserved iii

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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.
iv © ISO 2023 – All rights reserved
iv © ISO 2023 – All rights reserved

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ISO/FDIS 17665:2023(E)
Introduction
...