ISO 13408-2:2018/FDAmd 1
(Amendment)Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
- Status
- Not Published
- Technical Committee
- ISO/TC 198 - Sterilization of health care products
- Drafting Committee
- ISO/TC 198/WG 9 - Aseptic processing
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 06-Oct-2026
- Completion Date
- 06-Oct-2026
Buy Documents
ISO 13408-2:2018/FDAmd 1 - Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
REDLINE ISO 13408-2:2018/FDAmd 1 - Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
ISO 13408-2:2018/FDAmd 1 - Traitement aseptique des produits de santé — Partie 2: Filtration stérilisante — Amendement 1
ISO 13408-2:2018/FDAmd 1 is an ISO amendment to Part 2 of the aseptic processing of health care products series, focused on sterilizing filtration. It updates the 2018 text to align references, terminology and process controls with ISO 13408-1:2023, and it adds clearer risk-based guidance for filter selection, integrity testing and validation.
What does ISO 13408-2:2018/FDAmd 1 specify?
ISO 13408-2:2018/FDAmd 1 specifies changes to the sterilizing filtration part of aseptic processing for health care products. In practice, it refines how organizations control contamination risk, qualify filters and filter systems, and document testing and maintenance.
The amendment is organized by affected clauses and updates the following areas:
- Clause 2 - normative references
- Clause 3 - terms and definitions
- Clause 4 - general requirements
- Clause 5.2.2 - filter selection factors
- Clause 6 - risk management and process controls
- Clause 7.1.2 - bioburden and masking risk
- Clause 8.4.2 - integrity testing before use
- Clause 9.2.1.5 - bacterial challenge testing
- Clauses 10.4, 11.4, 12.2, 12.3.1 and 12.3.3 - records, maintenance and review
- Bibliography
What are the key requirements of ISO 13408-2:2018/FDAmd 1?
Risk management and documented control
ISO 13408-2:2018/FDAmd 1 places sterilizing filtration activities under quality risk management (QRM) principles. Clause 4.1 requires controlled processes for documentation, management responsibility, resources, supplier inputs, process understanding, traceability and nonconforming product handling.
Clause 4.2 requires filtration-specific training to be implemented and documented. That matters because operators need to understand filtration procedures, integrity testing, failure investigation, assembly, installation, cleaning and sterilization before they run the process.
Clause 4.3 requires specified purchasing procedures and a written agreement with the filter manufacturer about changes in manufacturing conditions that could affect defined fluid and process parameters. Clause 4.4 requires calibration of all equipment, including test instrumentation. In practice, this means the filtration process depends on controlled supply, traceable filters and trustworthy measurements.
Filter selection, integrity testing and PUPSIT
Clause 5.2.2 adds selection factors for the filter and the process, including the fluid’s effect on the membrane, fluid bioburden, process conditions such as flow rate and hold times, and the effect of sterilizing the filter on performance. These points matter because a filter that works in one fluid or cycle may not behave the same in another.
Clause 6.2.2 requires a scientifically based risk assessment when selecting filters and filtration equipment. The amendment adds explicit consideration of PUPSIT, which is the pre-use-post-sterilization integrity test. The practical point is that the user must weigh the risk of flawed filters being masked against the risk of contaminating the process through improper or inadequate pre-use testing.
Clause 6.4.5 states that integrity testing of the filtration system can be needed after sterilization and before fluid filtration when PUPSIT is indicated. Clause 8.4.2 ties the decision to omit a pre-use test to a documented risk assessment. In use, this means the decision must be justified, not assumed.
Validation, challenge testing and records
Clause 7.1.2 expands the note on bioburden control and filter flaw masking. It emphasizes keeping pre-sterilizing filtration bioburden well below validated retention performance and understanding fluid chemistry and processing conditions that might swell, occlude or bind the membrane.
Clause 9.2.1.5 requires the bacterial challenge test fluid to be the fluid to be filtered where possible, with viability of the challenge organism assessed over the worst-case test time. If the fluid is inhibitory, a simulation fluid or changed simulation conditions are used. This affects validation planning because the test must reflect the real process as closely as practical.
Clauses 10.4, 11.4, 12.2, 12.3.1 and 12.3.3 reinforce records retention, nonconforming product handling when records are unavailable, periodic verification of instrumentation accuracy and reliability, and retention of maintenance and review records. For users, that means the evidence for process control has to be complete and retrievable.
What terms does ISO 13408-2:2018/FDAmd 1 define?
- filter integrity test - a non-destructive physical technical operation that can be correlated to the bacterial retention capability of a filter assembly.
- fluid - a substance that continually deforms under applied shear force; examples include liquid, gas, vapour or plasma.
- sterilizing filtration - removal of viable microorganisms from fluids by passing the fluid through a filter under specified process conditions to produce a sterile filtrate.
- quality risk management (QRM) - the risk-based approach used here to control microbiological contamination and material effects on product quality.
- pre-use-post-sterilization integrity test (PUPSIT) - the integrity test performed after filter sterilization and before fluid filtration when indicated.
- bioburden - the microbial load in the fluid before sterilizing filtration, which must be controlled well below the validated retention performance of the system.
Who uses ISO 13408-2:2018/FDAmd 1?
ISO 13408-2:2018/FDAmd 1 is used by manufacturers of health care products, including teams responsible for aseptic processing and sterilizing filtration. It is also used by quality assurance, validation, microbiology, manufacturing and engineering staff who select filters, set up integrity testing, validate microbial retention and keep process records. Filter manufacturers and suppliers use it when agreeing change control and product traceability with users.
What changed in ISO 13408-2:2018/FDAmd 1 from the previous edition?
This amendment updates Clause 2 normative references to ISO 11139 and ISO 13408-1:2023, and removes ISO 13485 from that clause. It revises Clause 3 terms and definitions, including the wording for filter integrity test, fluid and sterilizing filtration.
It replaces Clause 4 with updated general requirements on QRM, training, purchasing, traceability and calibration. It adds filter-selection risk factors in 5.2.2, strengthens the risk-assessment language in 6.2.2, and adds PUPSIT-related wording in 6.4.5 and 8.4.2. It also updates the bacterial challenge test, records, maintenance and bibliography.
Which standards are used with ISO 13408-2:2018/FDAmd 1?
- ISO 11139 - provides the sterilization vocabulary used for the amended terms and definitions.
- ISO 13408-1:2023 - provides the general requirements for aseptic processing of health care products and is the main companion part cited throughout the amendment.
Clause 2 removes ISO 13485 from the normative references of this amendment.
What does the ISO 13408-2:2018/FDAmd 1 document contain?
ISO 13408-2:2018/FDAmd 1 contains targeted revisions to the sterilizing filtration requirements rather than a full rewritten standard. The document updates normative references, defined terms, risk management text and operational controls around filter selection, integrity testing, bioburden, validation and records.
It also adds guidance on when PUPSIT is considered, how to assess fluid effects on filter membranes, and how to handle fluids that interfere with bacterial challenge testing. The bibliography is updated with supporting references on filter masking, integrity testing and fluid effects.
Relations
- Effective Date
- 12-Feb-2026
- Amends
ISO 13408-2:2018 - Aseptic processing of health care products — Part 2: Sterilizing filtration - Effective Date
- 27-Jul-2024
Buy Documents
ISO 13408-2:2018/FDAmd 1 - Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
REDLINE ISO 13408-2:2018/FDAmd 1 - Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
ISO 13408-2:2018/FDAmd 1 - Traitement aseptique des produits de santé — Partie 2: Filtration stérilisante — Amendement 1
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Frequently Asked Questions
ISO 13408-2:2018/FDAmd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1". This standard covers: Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
ISO 13408-2:2018/FDAmd 1 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 13408-2:2018/FDAmd 1 has the following relationships with other standards: It is inter standard links to EN ISO 13408-2:2018/FprA1, ISO 13408-2:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 13408-2:2018/FDAmd 1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
Amendment
ISO 13408-2:2018/
FDAM 1
ISO/TC 198
Aseptic processing of health care
Secretariat: ANSI
products —
Voting begins on:
2026-10-06
Part 2:
Sterilizing filtration
Voting terminates on:
2026-12-01
AMENDMENT 1
Traitement aseptique des produits de santé —
Partie 2: Filtration stérilisante
AMENDEMENT 1
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO 13408-2:2018/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 13408-2:2018/FDAM 1:2026(en)
Amendment
ISO 13408-2:2018/
FDAM 1
ISO/TC 198
Aseptic processing of health care
Secretariat: ANSI
products —
Voting begins on:
Part 2:
Sterilizing filtration
Voting terminates on:
AMENDMENT 1
Traitement aseptique des produits de santé —
Partie 2: Filtration stérilisante
AMENDEMENT 1
© ISO 2026
All rights reserved.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
This ISO publication is protected by copyright and is owned by ISO and/or its licensors.
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
The content of this ISO publication is provided under licence, not sold. Use is subject to the applicable licence terms issued by ISO,
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
an ISO member body, or an authorized third-party distributor.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
Except as required for implementation or expressly permitted by a separate licence, no part of this ISO publication may be
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
reproduced, distributed, modified, used, or made available in any form or by any means – electronic or mechanical, including
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
Any use beyond the scope of the granted rights is prohibited and may result in legal action.
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
Reference number
ISO 13408-2:2018/FDAM 1:2026(en) © ISO 2026
ii
ISO 13408-2:2018/FDAM 1:2026(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 204,
Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
A list of all parts in the ISO 13408 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.
iii
ISO 13408-2:2018/FDAM 1:2026(en)
Aseptic processing of health care products —
Part 2:
Sterilizing filtration
AMENDMENT 1
Clause 2, Normative references
Remove the reference to ISO 11139.
Replace the references to ISO 13408-1:2008 and ISO 13408-1:2008/Amd 1 with the following:
ISO 13408-1:2023, Aseptic processing of health care products — Part 1: General requirements
Remove the reference to ISO 13485.
Clause 3, Terms and definitions
Replace first sentence with the following:
For the purposes of this document, the terms and definitions given in ISO 13408-1 and the following
apply.
3.1
Add source:
[SOURCE: ISO 11139:2018, 3.19, modified — “microorganisms from a liquid bacterial suspension” has been
changed to “organisms from liquid bacterial suspension”.]
3.2
Add source:
[SOURCE: ISO 11139:2018, 3.23, modified — Note 1 to entry added.]
3.3
Add source:
[SOURCE: ISO 11139:2018, 3.41]
3.4
ISO 13408-2:2018/FDAM 1:2026(en)
Modify source as follows:
[SOURCE: ISO 10993-12:2021, 3.7, modified — The term “extractable substance” has been changed to
“extractable”; “medical device” has been changed to “filter”; “conditions of clinical use” has been changed to
“normal use conditions”.]
3.5
Add source:
[SOURCE: ISO 11139:2018, 3.117]
3.6, 3.7
Switch order of 3.6 and 3.7 to retain alphabetical order of terms and definitions and add sources to read as
follows:
3.6
filter integrity test
non-destructive physical technical operation that can be correlated to the bacterial retention capability of a
filter assembly
[SOURCE: ISO 11139:2018, 3.118]
3.7
fluid
substance that continually deforms (flows) under applied shear force
EXAMPLE Liquid, gas, vapour or plasma.
Note 1 to entry: The filtrate of the fluid subjected to the sterilizing filtration (3.11) process might be the product to
be produced, a part of the formulation, a gas used to provide overpressure or a process gas released into the aseptic
processing area (e.g. gases released from air actuated valves).
[SOURCE: ISO 11139:2018, 3.120, modified — Note 1 to entry added.]
3.8
Add source:
[SOURCE: ISO 11139:2018, 3.152]
3.9
Add source:
[SOURCE: ISO 11139:2018, 3.176, modified — Note 1 to entry added.]
3.10
Add source:
[SOURCE: ISO 11139:2018, 3.196, modified — Note 1 to entry added.]
ISO 13408-2:2018/FDAM 1:2026(en)
3.11
Add source for entry 3.11 and change cross-reference 3.6 to 3.7 to read as follows:
3.11
sterilizing filtration
removal of viable microorganisms (3.9) from fluids (3.7) by passage of the fluid through a filter (3.5) under
specified process conditions resulting in a sterile filtrate
[SOURCE: ISO 11139:2018, 3.276]
Clause 4
Replace the text of Clause 4 with the ISO/TC 198 Common Clause 4 text, with minor modifications, as follows:
4 General
4.1 Sterilizing filtration activities are undertaken in accordance with quality risk management (QRM)
principles to manage microbiological contamination and material effects risks to product quality. To
ensure the consistent implementation of the requirements specified in this document, the necessary
processes shall be established, implemented and maintained. Processes of particular importance in
relation to sterilizing filtration include, but are not limited to:
— control of documentation, including records;
— assignment of management responsibility;
— provision of adequate resources, including competent human resources and infrastructure;
— control of the product provided by external parties;
— judicious decision-making during product lifecycle, including modernizing and improving sterilizing
filtration processes to further reduce risks to product quality;
— establishment of and maintenance of the sterilizing filtration process;
— investment in sterilizing filtration process understanding and monito
...
ISO 13408-2:2018/FDAMFDAmd 1:2026(en)
ISO/TC 198/WG 9
Secretariat: ANSI
Date: 2026-05-0609-22
Aseptic processing of health care products — —
Part 2:
Sterilizing filtration —
AMENDMENT 1
Traitement aseptique des produits de santé —
Partie 2: Filtration stérilisante
AMENDEMENT 1
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ISO #####-#:####(X)
FDIS stage
© ISO #### – All rights reserved
ISO 13408-2:2018/FDAMFDAmd 1:2026(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
iii
ISO #####-#:####(X 13408-2:2018/FDAmd 1(en)
Contents
© ISO #### 2026 – All rights reserved
iv
ISO 13408-2:2018/FDAMFDAmd 1:2026(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'sISO’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 204,
Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
A list of all parts in the ISO 13408 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.
v
ISO 13408-2:2018/FDAM 1:2026(en)
Aseptic processing of health care products —
—
Part 2:
Sterilizing filtration
AMENDMENT 1
Clause 2, Normative references
ReplaceRemove the reference to ISO 11139 with:.
ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related
equipment and process standards
Replace the references to ISO 13408-1:2008 and ISO 13408-1:2008/Amd 1 with the following:
ISO 13408-1:2023, Aseptic processing of health care products — Part 1: General requirements
Remove the reference to ISO 13485.
Clause 3, Terms and definitions
Replace first sentence with the following:
For the purposes of this document, the terms and definitions given in ISO 13408-1 and the following apply.
3.1
Add source:
[SOURCE: ISO 11139:2018, 3.19, modified — “microorganisms from a liquid bacterial suspension” has been
changed to “organisms from liquid bacterial suspension”.]
3.2
Add source:
[SOURCE: ISO 11139:2018, 3.23, modified — Note 1 to entry added.]
3.3
Add source:
[SOURCE: ISO 11139:2018, 3.41]
3.4
Modify source as follows:
[SOURCE: ISO 10993-12:2021, 3.7, modified — The term “extractable substance” has been changed to
“extractable”; “medical device” has been changed to “filter”; “conditions of clinical use” has been changed to
“normal use conditions”.]
3.5
Add source:
[SOURCE: ISO 11139:2018, 3.117]
3.6, 3.7
Switch order of 3.6 and 3.7 to retain alphabetical order of terms and definitions and add sources to read as
follows:
3.6
filter integrity test
non-destructive physical technical operation that can be correlated to the bacterial retention capability of a
filter assembly
[SOURCE: ISO 11139:2018, 3.118]
3.7
fluid
substance that continually deforms (flows) under applied shear force
EXAMPLE Liquid, gas, vapour or plasma.
Note 1 to entry: The filtrate of the fluid subjected to the sterilizing filtration (3.11) process might be the product to be
produced, a part of the formulation, a gas used to provide overpressure or a process gas released into the aseptic
processing area (e.g. gases released from air actuated valves).
[SOURCE: ISO 11139:2018, 3.120, modified — Note 1 to entry added.]
3.8
Add source:
[SOURCE: ISO 11139:2018, 3.152]
© ISO #### 2026 – All rights reserved
ISO 13408-2:2018/FDAMFDAmd 1:2026(en)
3.9
Add source:
[SOURCE: ISO 11139:2018, 3.176, modified — Note 1 to entry added.]
3.10
Add source:
[SOURCE: ISO 11139:2018, 3.196, modified — Note 1 to entry added.]
3.11
Add source for entry 3.11 and change cross-reference 3.6 to 3.7 to read as follows:
3.11
sterilizing filtration
removal of viable microorganisms (3.9) from fluids (3.7) by passage of the fluid through a filter (3.5) under
specified process conditions resulting in a sterile filtrate
[SOURCE: ISO 11139:2018, 3.276]
Clause 4
Replace the text of Clause 4 with the ISO/TC 198 Common Clause 4 text, with minor modifications, as follows:
4 General
4.1 Sterilizing filtration activities are undertaken in accordance with quality risk management (QRM)
principles to manage microbiological contamination and material effects risks to product quality. To
ensure the consistent implementation of the requirements specified in this document, the necessary
processes shall be established, implemented and maintained. Processes of particular importance in
relation to sterilizing filtration include, but are not limited to:
— — control of documentation, including records;
— — assignment of management responsibility;
— — provision of adequate resources, including competent human resources and
infrastructure;
— — control of the product provided by external parties;
— — judicious decision-making during product lifecycle, including modernizing and
improving sterilizing filtration processes to further reduce risks to product quality;
— — establishment of and maintenance of the sterilizing filtration process;
— — investment in sterilizing filtration process understanding and monitoring of
process performance;
— — identification and traceability of the product throughout the process; and
— — control of a non-conforming product including related corrective and preventive
actions.
NOTE Quality management is a management function that direc
...
PROJET FINAL
Amendement
ISO 13408-2:2018/
FDAM 1
ISO/TC 198
Traitement aseptique des produits
Secrétariat: ANSI
de santé —
Début de vote:
2026-10-06
Partie 2:
Filtration stérilisante
Vote clos le:
2026-12-01
AMENDEMENT 1
Aseptic processing of health care products —
Part 2: Sterilizing filtration
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO 13408-2:2018/FDAM 1:2026(fr) © ISO 2026
PROJET FINAL
ISO 13408-2:2018/FDAM 1:2026(fr)
Amendement
ISO 13408-2:2018/
FDAM 1
ISO/TC 198
Traitement aseptique des produits
Secrétariat: ANSI
de santé —
Début de vote:
Partie 2: 2026-10-06
Filtration stérilisante
Vote clos le:
2026-12-01
AMENDEMENT 1
Aseptic processing of health care products —
Part 2: Sterilizing filtration
AMENDMENT 1
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2026
LES DESTINATAIRES DU PRÉSENT PROJET SONT
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ISO 13408-2:2018/FDAM 1:2026(fr) © ISO 2026
ii
ISO 13408-2:2018/FDAM 1:2026(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
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d'un ou de plusieurs brevets. L'ISO ne prend pas position quant à la preuve, à la validité et à l'applicabilité
de tout droit de propriété revendiqué à cet égard. À la date de publication du présent document, l'ISO
n'avait pas reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d'avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l'adresse www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
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Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/iso/fr/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 198, Stérilisation des produits de santé,
en collaboration avec le comité technique CEN/TC 204, Stérilisation des dispositifs médicaux, du Comité
européen de normalisation (CEN), conformément à l'accord de coopération technique entre l'ISO et le CEN
(Accord de Vienne).
Une liste de toutes les parties de la série ISO 13408 se trouve sur le site web de l'ISO.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l'adresse www.iso.org/fr/members.html.
iii
ISO 13408-2:2018/FDAM 1:2026(fr)
Traitement aseptique des produits de santé —
Partie 2:
Filtration stérilisante
AMENDEMENT 1
Article 2, Références normatives
Supprimer la référence à l'ISO 11139.
Remplacer les références à l'ISO 13408-1:2008 et à l'ISO 13408-1:2008/Amd 1 par ce qui suit:
ISO 13408-1:2023, Traitement aseptique des produits de santé — Partie 1: Exigences générales
Supprimer la référence à l'ISO 13485.
Article 3, Termes et définitions
Remplacer la première phrase par ce qui suit:
Pour les besoins du présent document, les termes et définitions de l'ISO 13408-1 ainsi que les suivants,
s'appliquent.
3.1
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.19, modifié — “micro-organismes d'une suspension bactérienne liquide” a été
remplacé par “organismes d'une suspension bactérienne liquide”.]
3.2
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.23, modifié — La Note 1 à l'article a été ajoutée.]
3.3
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.41]
3.4
ISO 13408-2:2018/FDAM 1:2026(fr)
Modifier la source comme suit:
[SOURCE: ISO 10993-12:2021, 3.7, modifié — Le terme “substance extractible” a été remplacé par
“extractible”; “dispositif médical” a été remplacé par “filtre”; “conditions d'utilisation clinique” a été remplacé
par “conditions normales d'utilisation”.]
3.5
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.117]
3,6, 3.7
Inverser l'ordre de 3.6 et 3.7 pour conserver l'ordre alphabétique des termes et définitions et ajouter les
sources à consulter comme suit:
3.6
essai d'intégrité du filtre
opération technique non destructive qui peut être corrélée à la capacité de rétention bactérienne d'un filtre
complet
[SOURCE: ISO 11139:2018, 3.118]
3.7
fluide
substance qui se déforme en permanence (s'écoule) sous l'effet d'une force de cisaillement appliquée
EXEMPLE Liquide, gaz, vapeur ou plasma.
Note 1 à l'article: Le filtrat du fluide soumis au processus de filtration stérilisante (3.11) peut être le produit à obtenir,
une partie de la formulation, un gaz utilisé pour fournir une surpression ou un gaz de traitement libéré dans la zone de
traitement aseptique (par exemple: gaz dégagés par des valves à commande pneumatique).
[SOURCE: ISO 11139:2018, 3.120, modifié — La Note 1 à l'article a été ajoutée.]
3.8
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.152]
3.9
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.176, modifié — La Note 1 à l'article a été ajoutée.]
3.10
Ajouter la source:
[SOURCE: ISO 11139:2018, 3.196, modifié — La Note 1 à l'article a été ajoutée.]
ISO 13408-2:2018/FDAM 1:2026(fr)
3.11
Ajouter la source pour l'entrée 3.11 et remplacer la référence 3.6 par 3.7 comme suit:
3.11
filtration stérilisante
élimination de micro-organismes (3.9) viables de fluides (3.7) en faisant passer le fluide au travers d'un
filtre (3.5) dans les conditions spécifiées du processus, ce qui permet d'obtenir un filtrat stérile
[SOURCE: ISO 11139:2018, 3.276]
Article 4
Remplacer le texte de l'Article 4 par le texte de l'Article 4 commun de l'ISO/TC 198, avec des modifications
mineures, comme suit:
4 Généralités
4.1 Les activités de filtration stérilisante sont entreprises conformément aux principes de gestion des
risques de qualité (QRM), pour gérer les risques de contamination microbiologique et des effets ayant
trait aux matériaux en lien avec la qualité du produit. Afin de garantir la mise en œuvre cohérente des
exigences spécifiées dans le présent document, il faut établir, mettre en place et entretenir les procédés
requis. Les procédés suivants, notamment, revêtent une importance particulière dans le cadre de la
filtration stérilisante:
— le contrôle de la documentation, y compris des enregistrements;
— l'attribution des responsabilités de la direction;
— l'allocation des ressources adéquates, y compris des ressources humaines et des infrastructures
appropriées;
— le contrôle des produits fournis par des tiers;
— la prise de décisions judicieuses au cours du cycle de vie du produit, y compris la modernisation
et l'amélioration des procédés de filtration stérilisante pour renforcer la réduction des risques en
lien avec la qualité du produit;
— l'établissement et la préservation du procédé de filtration stérilisante;
— l'investissement dans la compréhe
...