ISO 18242:2016

INTERNATIONAL ISO
STANDARD 18242
First edition
2016-09-01
Cardiovascular implants and
extracorporeal systems — Centrifugal
blood pumps
Implants cardiovasculaires et systèmes extracorporels — Pompes
sanguines centrifuges
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

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 Connector integrity . 3
4.3 Performance characteristics. 3
4.3.1 Hydraulic performance . 3
4.3.2 Blood cell damage . 3
4.3.3 Bearing durability . 4
4.3.4 Shelf life . 4
5 Tests and measurements to determine compliance with this document .4
5.1 General . 4
5.1.1 Tests and measurements . 4
5.1.2 Operating variables . 4
5.1.3 Temperature . 4
5.1.4 Relationship between variables. 4
5.1.5 Procedures . 5
5.1.6 Driver/console . 5
5.2 Biological characteristics . 5
5.2.1 Sterility and non-pyrogenicity . 5
5.2.2 Biocompatibility . 5
5.3 Physical characteristics . 5
5.3.1 Blood pathway integrity . 5
5.3.2 Prime volume . 5
5.3.3 Connectors . 5
5.4 Performance characteristics. 6
5.4.1 Hydraulic performance . 6
5.4.2 Blood cell damage . 6
5.4.3 Bearing wear . 7
5.4.4 Shelf life . 7
6 Information supplied by the manufacturer . 7
6.1 Information on the device . 7
6.2 Information on the packaging . 8
6.2.1 Unit container . 8
6.2.2 Shipping container . 8
6.3 Information in the accompanying documents . 8
6.4 Information in the accompanying documents in a prominent form . 9
7 Packaging . 9
Bibliography .10
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
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on the ISO list of patent declarations received (see www.iso.org/patents).
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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.
iv © ISO 2016 – All rights reserved

Introduction
This document is intended to ensure that devices designed to provide continuous flow of blood in
support of, or as a substitution for, the normal pumping function of the heart have been adequately tested
for both their safety and function, and that extracorporeal device characteristics are appropriately
disclosed when labelling the device.
This document therefore contains procedures to be used for evaluation of extracorporeal centrifugal
blood pumps. Test procedures for determination of the hydraulic performance, 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 centrifugal blood pump 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 centrifugal blood pumps 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 centrifugal blood pumps. Non-
specific requirements are covered by references to other International Standards listed in Clause 2.
INTERNATIONAL STANDARD ISO 18242:2016(E)
Cardiovascular implants and extracorporeal systems —
Centrifugal blood pumps
1 Scope
This document specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps,
whether coated, non-surface modified, or surface-modified, intended for producing blood flow during
extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion
during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted
venous drainage, or extracorporeal membrane oxygenation.
This document does not apply to
— centrifugal pumps used as ventricular assist devices, and
— other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
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 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 — Part4: Selection of tests for interactions 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, Sterilization of health-care products — Ethylene oxide — Requirements for the 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 medi
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