ISO 18241:2016

INTERNATIONAL ISO
STANDARD 18241
First edition
2016-08-15
Cardiovascular implants and
extracorporeal systems —
Cardiopulmonary bypass systems —
Venous bubble traps
Implants cardiovasculaires et systèmes extracorporels — Systèmes de
pontage cardiopulmonaire — Pièges à bulles veineuses
Reference number
ISO 18241:2016(E)
©
ISO 2016

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ISO 18241:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved

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ISO 18241:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Biological characteristics . 3
4.1.1 Sterility and non-pyrogenicity . 3
4.1.2 Biocompatibility . 3
4.2 Physical characteristics . 3
4.2.1 Blood pathway integrity . 3
4.2.2 Prime volume . 3
4.2.3 Connectors . 3
4.3 Performance characteristics. 3
4.3.1 Blood cell damage . 3
4.3.2 Air removal efficiency . 3
4.3.3 Flow rate capacity . 3
4.3.4 Shelf life . 4
5 Tests and measurements to determine compliance with this document .4
5.1 General . 4
5.2 Biological characteristics . 4
5.2.1 Sterility and non-pyrogenicity . 4
5.2.2 Biocompatibility . 4
5.3 Physical characteristics . 4
5.3.1 Blood pathway integrity . 4
5.3.2 Prime volume . 4
5.3.3 Connectors . 4
5.4 Performance characteristics. 5
5.4.1 Blood cell damage . 5
5.4.2 Air removal efficiency . 6
5.4.3 Flow rate and pressure drop . 6
5.4.4 Shelf life . 7
6 Information supplied by the manufacturer . 7
6.1 Information on the venous bubble trap . 7
6.2 Information on the packaging . 7
6.2.1 Information on the unit container . 7
6.2.2 Information on the shipping container . 7
6.3 Information in the accompanying documents . 8
6.4 Information in the accompanying documents in a prominent form . 8
7 Packaging . 8
Bibliography . 9
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ISO 18241:2016(E)

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 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.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
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ISO 18241:2016(E)

Introduction
This document is intended to ensure that devices designed to remove air entering the venous line
during surgical procedures requiring extracorporeal circulatory support have been adequately tested
for both their safety and function, and that extracorporeal device characteristics are appropriately
disclosed when labeling the device.
This document therefore contains procedures to be used for evaluation of extracorporeal venous bubble
traps. Test procedures for determination of the air removal efficiency, blood cell damage and other
performance characteristics 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 a venous bubble trap that will suit the needs of the patient.
This document also includes minimum reporting requirements, which will allow the user to compare
performance characteristics of venous bubble traps of different designs in a standard way.
This document makes reference to other International Standards in which methods for determination
of characteristics common to medical devices can be found.
Requirements for animal and clinical studies have not been included in this document.
Such studies may be part of a manufacturer’s quality system.
This document contains only those requirements that are specific to venous bubble traps. Nonspecific
requirements are covered by references to other International Standards listed in the normative
references section.
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INTERNATIONAL STANDARD ISO 18241:2016(E)
Cardiovascular implants and extracorporeal systems —
Cardiopulmonary bypass systems — Venous bubble traps
1 Scope
This document specifies requirements for sterile, single-use, venous bubble traps intended to remove
air entering the venous line during surgical procedures requiring extracorporeal circulatory support,
which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or
venovenous bypass for liver transplantation.
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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment
— Part 2: Lock fittings
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 interaction with blood
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses.
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at http://www.electropedia.org/
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ISO 18241:2016(E)

3.1
venous bubble trap
device for removing air from the venous line of an extracorporeal circuit
3.2
blood pathway
blood-contacting surfaces of
...