ISO 13408-2:2018/FDAmd 1

• 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 9 - Aseptic processing
• Current Stage: 5000 - FDIS registered for formal approval
• Start Date: 21-Jul-2026
• Completion Date: 08-May-2026

• Consolidates: EN ISO 13408-2:2018/prA1:2025 - Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAmd1:2025)
• 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

Overview

ISO 13408-2:2018/FDAmd 1 is an amendment to ISO 13408-2, the standard for aseptic processing of health care products - Part 2: Sterilizing filtration. This update focuses on the sterilizing filtration process, supporting better alignment with current terminology, risk management practices, and related ISO references.

For organizations involved in medical device sterilization, pharmaceutical manufacturing, and other health care product workflows, this amendment helps clarify expectations for filter integrity testing, process control, and documentation. It is especially relevant where sterile filtrate quality and microbiological control are critical to product safety.

Key Topics

This amendment strengthens several practical aspects of sterilizing filtration standards:

• Normative references updates

  • Replaces and removes selected references to align with current ISO documents
  • Adds reference to ISO 11139 and updates related standards usage

• Definitions and terminology

  • Revises and adds terms connected with filtration, fluids, and microorganisms
  • Improves consistency with broader sterilization of health care products vocabulary

• Risk management

  • Emphasizes quality risk management (QRM) in sterilizing filtration activities
  • Highlights the need to manage microbiological contamination and product quality risks
  • Supports documented decision-making across the product lifecycle

• Operator competence and process control

  • Reinforces training for filtration procedures, failure modes, integrity testing, and installation
  • Confirms the importance of equipment calibration, traceability, and maintenance records

• Integrity testing and PUPSIT

  • Clarifies considerations for pre-use - post-sterilization integrity test (PUPSIT)
  • Notes the need for documented risk assessment when deciding whether to omit pre-use integrity testing

• Bioburden and filter performance

  • Addresses factors that may affect filter membrane behavior and integrity test values
  • Notes the potential for filter flaw masking and the importance of process conditions

Applications

ISO 13408-2:2018/FDAmd 1 is useful for teams responsible for:

• Aseptic manufacturing
• Sterilizing-grade filtration systems
• Quality assurance and validation
• Filter selection and qualification
• Regulatory compliance and audit preparation
• Documentation of filtration records and maintenance

It provides practical value for manufacturers seeking to strengthen sterilization validation, improve filtration reliability, and support safer health care product outcomes.

Related Standards

Key related standards and references include:

• ISO 13408-2 - Aseptic processing of health care products - Part 2: Sterilizing filtration
• ISO 13408-1:2023 - Aseptic processing of health care products - Part 1: General requirements
• ISO 11139 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 10993-12:2021 - Biological evaluation of medical devices - Sample preparation and reference materials

This amendment supports organizations seeking a clearer, more current framework for aseptic processing, sterile filtration, and health care product sterilization compliance.

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
photocopying, scanning, recording, or posting on internal or external digital platforms. TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
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: [phone]
Email: [e-mail]
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
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Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
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
...