ISO 8637-3:2018

INTERNATIONAL ISO
STANDARD 8637-3
First edition
2018-07
Extracorporeal systems for blood
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
©
ISO 2018
© ISO 2018
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ii © ISO 2018 – All rights reserved

Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Requirements . 2
4.1 Biological safety . 2
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 and ports . 3
4.4.4 Volume of the blood compartment . 5
4.4.5 Pressure drop of the blood compartment . 5
4.5 Performance characteristics. 5
4.5.1 Filtration rate . 5
4.5.2 Sieving coefficient . 5
4.5.3 Haemolytic characteristics . 6
4.6 Expiry date. 6
5 Test methods . 6
5.1 General . 6
5.2 Biological safety . 6
5.3 Sterility . 6
5.4 Non-pyrogenicity . 6
5.5 Mechanical characteristics. 7
5.5.1 Structural integrity . 7
5.5.2 Blood compartment integrity . 7
5.5.3 Blood compartment ports . 7
5.5.4 Blood compartment volume . 7
5.6 Plasma filtrate port. 7
5.7 Pressure drop . 7
5.7.1 Test solution. 7
5.7.2 Pressure drop test procedure . 7
5.8 Performance characteristics. 8
5.8.1 Filtration rate . 8
5.8.2 Sieving coefficient . 8
5.8.3 Haemolytic characteristics .10
5.9 Expiry date.10
6  Labelling .10
6.1 Labelling on the device .10
6.2 Labelling on unit containers .11
6.3 Labelling on the outer containers.11
6.4 Information to be given in the accompanying documentation .12
Bibliography .14
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following
URL: 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 first edition of ISO 8637-3:2018 cancels and replaces the second edition of ISO 13960:2010, which
has been technically revised. The following changes have been made:
— the Figures relating to connector dimensions have been revised.
A list of all the parts in the ISO 8637 series can be found on the ISO website.
iv © ISO 2018 – All rights reserved

Introduction
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.
If the plasmafilter is used with an extracorporeal circuit, the dimensions of the blood ports and filtrate
ports 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.
This document reflects the consensus of physicians, manufacturers and other interested parties for
devices that are approved for clinical use.
INTERNATIONAL STANDARD ISO 8637-3:2018(E)
Extracorporeal systems for blood purification —
Part 3:
Plasmafilters
1 Scope
This document specifies requirements and acceptance criteria (including test methods) for safety
related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have
been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of
ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access
devices, oxygenators or active medical devices. This document does not address the replacement fluid.
2  Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8637-1, Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions wi
...