oSIST prEN ISO 11607-3:2025
(Main)Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.
This document applies to both preformed sterile barrier systems and sterile barrier systems.
This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.
This document is intended to be used prior to process validation.
NOTE ISO 11607-2 provides requirements for process specification and process validation.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Anforderungen an die Prozessentwicklung der Formgebung, Siegelung und des Zusammenstellens (ISO/DIS 11607-3:2025)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Exigences relatives à la mise au point des procédés de formage, scellage et assemblage (ISO/DIS 11607-3:2025)
Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Zahteve za razvoj procesa oblikovanja, tesnjenja in sestavljanja (ISO/DIS 11607-3:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Zahteve za
razvoj procesa oblikovanja, tesnjenja in sestavljanja (ISO/DIS 11607-3:2025)
Packaging for terminally sterilized medical devices - Part 3: Requirements for process
development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3:
Anforderungen an die Prozessentwicklung der Formgebung, Siegelung und des
Zusammenstellens (ISO/DIS 11607-3:2025)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Exigences
relatives à la mise au point des procédés de formage, scellage et assemblage (ISO/DIS
11607-3:2025)
Ta slovenski standard je istoveten z: prEN ISO 11607-3
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 11607-3
ISO/TC 198
Packaging for terminally sterilized
Secretariat: ANSI
medical devices —
Voting begins on:
Part 3: 2025-09-01
Requirements for process
Voting terminates on:
2025-11-24
development for forming, sealing
and assembly
Emballages des dispositifs médicaux stérilisés au stade
terminal —
Partie 3: Exigences relatives au développement des procédés de
formage, scellage et assemblage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 11607-3:2025(en)
DRAFT
ISO/DIS 11607-3:2025(en)
International
Standard
ISO/DIS 11607-3
ISO/TC 198
Packaging for terminally sterilized
Secretariat: ANSI
medical devices —
Voting begins on:
Part 3:
Requirements for process
Voting terminates on:
development for forming, sealing
and assembly
Emballages des dispositifs médicaux stérilisés au stade
terminal —
Partie 3: Exigences relatives au développement des procédés de
formage, scellage et assemblage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11607-3:2025(en)
ii
ISO/DIS 11607-3:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Quality systems .3
4.2 Risk management .3
4.3 Sampling .3
4.4 Test methods .3
4.5 Documentation .3
5 Process development. 3
5.1 General .3
5.2 Process development activities .3
5.3 Predetermined SBS specification(s) .4
5.4 Draft process specification . .5
5.5 Initial process risk analysis .5
5.6 Process variables .6
5.7 Initial process control and monitoring plans .7
5.8 Process specification .7
5.9 Process risk management plan .7
6 Process equivalence . 7
Annex A (informative) Guidance on establishing process parameters .11
Annex B (informative) First principles of heat sealing materials .16
Annex C (informative) Minimum heat sealing equipment features to support subsequent
validation, process control and monitoring .20
Annex D (informative) Guidance on evaluating the equivalence of sealing outputs .24
Bibliography .27
iii
ISO/DIS 11607-3:2025(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,
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).
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 102,
Sterilizers for medical purposes, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
A list of all parts in the ISO 11607 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.
iv
ISO/DIS 11607-3:2025(en)
Introduction
ISO 11607-1 and ISO 11607-2 specify requirements for the design and validation of sterile barrier systems for
terminally sterilized medical devices, and the validation requirements for manufacturing processes of sterile
barrier systems, respectively. The heat sealing of a sterile barrier system is critical to the maintenance of
sterile barrier integrity to the point of use, however, there is little content available for process development
in the current edition of ISO 11607-2.
This document specifies requirements for the development of heat sealing processes to meet sterile barrier
seal design requirements. A thorough development process with a high-quality output is an important
input to an efficient validation of the process. While a successful validation is essential to ensure the safety
of terminally sterilized medical devices, there is no intention to imply that the approach proposed in this
document is the only valid approach. User of this document can use it if they find it appropriate. Additionally,
this document specifies a process for documenting the equivalence of sealing processes which can be a
benefit to users in support of change control activities since it can create the basis to leverage the efforts
over a range of sealing equipment.
This document is intended for use by industrial manufacturers engaged in the design and development of
sterile barrier systems and sealing processes. Effective application of the requirements within requires
proficiency in design of experiment (DOE) methodologies and access to the requisite testing resources for
result evaluation. Producers of prefo
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