SIST EN ISO 13408-2:2018/oprA1:2025

SLOVENSKI STANDARD
01-december-2025
Aseptična proizvodnja izdelkov za zdravstveno nego - 2. del: Sterilizacija s
filtracijo - Dopolnilo A1 (ISO 13408-2:2018/DAmd1:2025)
Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1
(ISO 13408-2:2018/DAmd1:2025)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge – Teil 2:
Sterilfiltration – Änderung 1 (ISO 13408 2:2018/DAmd 1:2025)
Traitement aseptique des produits de santé - Partie 2: Filtration stérilisante -
Amendement 1 (ISO 13408-2:2018/DAmd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 13408-2:2018/prA1:2025
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
Amendment
ISO 13408-2:2018/
DAM 1
ISO/TC 198
Aseptic processing of health care
Secretariat: ANSI
products —
Voting begins on:
Part 2:
2025-10-24
Sterilizing filtration
Voting terminates on:
2026-01-16
AMENDMENT 1
Traitement aseptique des produits de santé —
Partie 2: Filtration stérilisante
AMENDEMENT 1
ICS: 11.080.01
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 13408-2:2018/DAM 1:2025(en)

DRAFT
ISO 13408-2:2018/DAM 1:2025(en)
Amendment
ISO 13408-2:2018/
DAM 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
ICS: 11.080.01
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
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BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO 13408-2:2018/DAM 1:2025(en)

ii
ISO 13408-2:2018/DAM 1:2025(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 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/DAM 1:2025(en)
Aseptic processing of health care products —
Part 2:
Sterilizing filtration
AMENDMENT 1
Clause 2, Normative references
1)
Replace the reference and title of “ISO 11139, …” with:
ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related
equipment and process standards
Add the following reference:
ISO 11139:2018/Amd 1:2024, Sterilization of health care products — Vocabulary of terms used in
sterilization and related equipment and process standards — Amendment 1: Amended and additional terms
and definitions
Delete ISO 13408-1:2008 and ISO 13408-1:2008/Amd. 1 and replace with the following:
ISO 13408-1:2023, Aseptic processing of health care products — Part 1: General requirements

Remove entry for ISO 13485, Medical devices — Quality management systems — Requirements for regulatory
purposes and move to the Bibliography as:
[10] ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

Remove entry for ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for
the development, validation and routine control of a sterilization process for medical devices and move to the
Bibliography as:
[11] ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices

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]

ISO 13408-2:2018/DAM 1:2025(en)

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
Add source:
[SOURCE: ISO 10993-12:2021, 3.7, modified — The wording of the term and definition has been modified.]

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 Example, Note 1 to
entry and 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 13408-2:2018/DAM 1:2025(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 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, Quality system elements
Replace the text of Clause 4 with the ISO/TC 198 Common Clause 4 text, with minor modifications, as follows:
4  General
4.1  Sterilising 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 sterilising 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 sterilising
filtration processes to further reduce risks to product quality,
— establishment of and maintenance of the sterilising filtration process,
— investment in sterilising 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.

ISO 13408-2:2018/DAM 1:2025(en)
NOTE Quality management is a management function that directs and controls an organisation in rela-
tion to quality. The essential concepts of good manufacturing practice (GMP), quality control and quality
assurance are interconnected within the context of quality management. Their significance in sterilising
filtration of medicines and CBHPs is described in national and regional codes of GMP. For medical devices,
ISO 13485 covers all stages of the product lifecycle in the context of quality management systems for
regulatory purposes. National and/or regional regulatory requirements for the provision of health care
products can require the implementation of a full quality management system and the assessment of that
system by a recognized conformity assessment body.
4.2  Operator training specific to filtration activities shall be implemented and documented for the
following:
a) filtration procedures, modes of failure and needed precautions;
b) integrity test theory and practice;
c) failure investigation procedures and measures taken in case of integrity test deviations;
d) filter assembly procedure (including aseptic technique if required);
e) filter installation, cleaning and sterilization procedures.
4.3  Procedures for purchasing filters and filtration equipment shall be specified.
There shall be a written agreement between the filter user and filter manufacturer that the filter
manufacturer will notify the filter user of any changes in the filter manufacturing conditions with
potential to affect the defined fluid and process parameters.
Procedures for identification and traceability of filters shall be specified.
4.4  A process shall be specified for the calibration of all equipment, including instrumentation for test
purposes, used in meeting the requirements of this document.

5.2.2
Add an additional bullet point as d) and rename the following bullet points accordingly [i.e. d) becomes e), .]:
d) potential for the fluid to alter the characteristics of the filter membrane, for instance, to cause a
[12]
change to the filter integrity test value between pre- and post-testing , e.g. a shift in bubble point
value;
6.2.1
Replace the text with the following:
6.2.1  The following additional requirements to ISO 13408-1:2023, Clauses 5 and 6 concerning risk
management apply.
6.2.2
Modify the introductory paragraph as follows:
6.2.2  A scientifically based risk assessment shall be performed during the selection of filter(s) and
filtration equipment, to confirm feasibility of the sterilizing filtration process and its controls to reduce
the risk of microbiological contamination. The risk assessment shall include, but is not limited to the
following:
ISO 13408-2:2018/DAM 1:2025(en)

6.2.2
Add a NOTE to c) as follows:
NOTE When PUPSIT is a consideration, the risk assessment includes deliberation of the risks and benefits
across the sterilizing filtration process, as well as to the finished product and the patient, for example,
the risk of loss of sterility assurance for finished product via microbiological contamination due to filter
[13],
flaw masking versus the risk of loss of sterility assurance for finished product via microbiological
contamination of the process due to improper or inadequate performance of PUPSIT. See also 4.3, 5.2.2,
6.2.3, 7.1.2 and 8.4.2.
6.4.5
Modify text of b) to address the updated reference to the following:
b) To maintain the sterility of the filtrate (see ISO 13408-1:2023, Clause 7).

6.4.5
Modify g) as follows:
g) To permit integrity testing of the filtration system, i.e. the sterilizing filter in its housing, post
sterilization and prior to fluid filtration where pre-use–post-sterilization integrity test (PUPSIT) is
indicated.
7.1.2, NOTE
Replace with the following:
NOTE 1 The intention is that the pre-sterilizing filtration bioburden is controlled and maintained at a level
substantially below the validated retention performance of the filtration system. A sound knowledge of
the chemistry of the fluid to be filtered is necessary to understand the potential for this fluid to adversely
affect the sterilizing filter with the potential for filter flaw masking e.g. occlusion, swelling or binding of
the membrane. In addition, it is necessary to determine processing conditions that do not pose a risk of
microscopic filter flaw masking and those that could favour such filter flaw masking.
NOTE 2 For microscopic filter flaw masking to occur, filter flaws need to be sufficiently small to not be
detected during pre-sterilization or post-use filter testing, but to then become large enough to allow
passage of microbiological contamination after filter sterilization, and to then become sufficiently small
again to be closed or masked due to the f
...