ISO 18193:2021

INTERNATIONAL ISO
STANDARD 18193
First edition
2021-08
Cardiovascular implants and artificial
organs — Cannulae for extracorporeal
circulation
Implants cardiovasculaires et organes artificiels — Canules pour
circulation extracorporelle
Reference number
©
ISO 2021
© ISO 2021
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ii © ISO 2021 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 Biological characteristics . 4
4.1.1 Sterility and non-pyrogenicity . 4
4.1.2 Biocompatibility . 4
4.2 Physical characteristics . 4
4.2.1 Blood pathway integrity . 4
4.2.2 Connectors . 4
4.2.3 Kink resistance . 5
4.2.4 Pull strength. 5
4.2.5 External surface . 5
4.2.6 Integrity (corrosion, abrasion, degradation) . 5
4.2.7 Radio-detectability . 5
4.2.8 Distance markings . 5
4.2.9 Lumen markings . 5
4.3 Performance characteristics. 5
4.3.1 Pressure drop . 5
4.3.2 Collapse resistance . . 6
4.3.3 Recirculation . 6
4.3.4 Blood cell damage . 6
4.3.5 Shelf life . 6
5 Tests and measurements for conformity to this document . 6
5.1 General . 6
5.2 Biological characteristics . 7
5.2.1 Sterility and non-pyrogenicity . 7
5.2.2 Biocompatibility . 7
5.3 Physical characteristics . 7
5.3.1 Blood pathway integrity . 7
5.3.2 Connectors . 7
5.3.3 Kink resistance . 7
5.3.4 Pull strength. 8
5.3.5 Integrity (corrosion, abrasion, degradation) . 8
5.3.6 Radio-detectability . 8
5.4 Performance characteristics. 9
5.4.1 Pressure drop . 9
5.4.2 Collapse resistance . . 9
5.4.3 Recirculation . 9
5.4.4 Blood cell damage .10
5.4.5 Shelf life .11
6 Information supplied by the manufacturer .11
6.1 Information to be given on the cannula . .11
6.2 Information to be given on the packaging .12
6.2.1 Unit container .12
6.2.2 Shipping container .12
6.3 Information to be given in the accompanying documents .12
6.4 Information to be given in the accompanying documents in a prominent form .13
7 Packaging .13
Annex A (informative) Examples of connectors .14
Annex B (informative) Test set-up for kink resistance .24
Annex C (informative) Test set-up for recirculation .26
Annex D (informative) Test set-up for blood cell damage .29
Bibliography .33
iv © ISO 2021 – All rights reserved

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 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.
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.
Introduction
This document is intended to ensure that cannulae designed to enable extracorporeal circulation (ECC)
have been adequately tested for both their safety and function, and that cannulae characteristics are
appropriately disclosed when labelling the device.
This document therefore contains procedures to be used for the evaluation of ECC cannulae. Type
test procedures for determination of the cannulae performance and blood cell damage are described,
although limits for these characteristics are not specified. Ready identification of the performance
characteristics should, however, assist the user in the selection of cannulae that suits the needs of the
patient.
This document also includes minimum reporting requirements, which allows the user to compare
performance characteristics of cannulae of different designs in a standard way.
This document makes reference t
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