ISO 8637-3:2024

International
Standard
ISO 8637-3
Second edition
Extracorporeal systems for blood
2024-05
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
ISO 8637-3:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 8637-3:2024(en)
Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 3
4.1 Biological safety and haemocompatibility .3
4.2 Sterility .3
4.3 Non-pyrogenicity .3
4.4 Mechanical characteristics .3
4.4.1 Structural integrity.3
4.4.2 Blood compartment integrity .3
4.4.3 Connectors .4
4.5 Performance characteristics .5
4.5.1 Plasma filtration rate .5
4.5.2 Sieving coefficient .6
4.5.3 Blood compartment volume .6
4.5.4 Blood compartment pressure drop .6
4.5.5 Haemolytic characteristics .6
4.6 Expiry date .6
5 Test methods . 6
5.1 General .6
5.2 Biological safety and haemocompatibility .7
5.3 Sterility .7
5.4 Non-pyrogenicity .7
5.5 Mechanical characteristics .7
5.5.1 Structural integrity.7
5.5.2 Blood compartment integrity .7
5.5.3 Connectors .8
5.6 Performance characteristics .11
5.6.1 Test solution .11
5.6.2 Plasma filtration rate — Test procedure .11
5.6.3 Sieving coefficient .11
5.6.4 Blood compartment volume . 13
5.6.5 Blood compartment pressure drop . 13
5.6.6 Haemolytic characteristics . 13
5.7 Expiry date .14
6  Labelling . 14
6.1 Labelling on the device.14
6.2 Labelling on unit containers . 15
6.3 Labelling on the outer containers . 15
6.4 Information to be given in the accompanying documentation .16
7  Packaging. 17
Bibliography .18

iii
ISO 8637-3:2024(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 document 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 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 8637-3:2018), which has been technically
revised.
The main changes are as follows:
— terms and definitions have been aligned with those defined in other parts of the ISO 8637 series;
— additional figures relating to a gauge to test dimensional compliance of connectors have been added;
— test methods for measurement of the sieving coefficient and haemolytic characteristics have been
revised;
— requirements for accompanying documentation have been revised and extended to ensure that the risk
of inadvertent use of a plasmafilter for haemofiltration is minimized.
A list of all the parts in the ISO 8637 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 8637-3:2024(en)
Introduction
This document is concerned with filters intended to perform plasma filtration in humans. If such a filter
is used with an extracorporeal circuit, the dimensions of the blood compartment connectors and filtrate
compartment connectors have been specified to ensure compatibility of the device with the extracorporeal
blood circuit specified in ISO 8637-2. The design and dimensions have been selected to minimize the risk of
leakage of blood and the ingress of air.
It was not found practicable to specify materials of construction. Therefore, this document only requires
that materials used have been tested, and that the testing methods and the results are made available upon
request.
There is no intention to specify, or to set limits on, the performance characteristics of the devices because
such restrictions are unnecessary for the qualified user and would limit the alternatives available when
choosing a device for a specific application.

v
International Standard ISO 8637-3:2024(en)
Extracorporeal systems for blood purification —
Part 3:
Plasmafilters
1 Scope
This document specifies requirements and test methods for plasmafilters, which are devices intended
to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the
requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter colle
...