ISO 18242:2016
(Main)Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
ISO 18242:2016 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. It does not apply to - centrifugal pumps used as ventricular assist devices, and - other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
Implants cardiovasculaires et systèmes extracorporels — Pompes sanguines centrifuges
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Standards Content (Sample)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18242
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-04-27 2015-07-27
Cardiovascular implants and extracorporeal systems —
Centrifugal blood pumps
Titre manque
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18242:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
ISO/DIS 18242:2015(E)
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
ISO/DIS 18424:xxxx
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
5 Tests and measurements to determine compliance with this International Standard . 4
6 Information supplied by the manufacturer . 7
7 Packaging . 8
ISO/DIS 18424:xxxx
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,
Part 3.
Draft International Standards adopted by the technical committees are circulated to the member
bodies for voting. Publication as an International Standard requires approval by at least 75 % of
the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may
be the subject of patent rights. ISO shall not be held responsible for identifying any or all such
patent rights.
International Standard ISO 18242 was prepared by Technical Committee ISO/TC 150, TC
Implants for surgery, Subcommittee 2, Cardiovascular implants and extracorporeal systems.
ISO/DIS 18424:xxxx
Introduction
This International Standard 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 labeling the device.
This International Standard 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 International Standard 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 International Standard 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 International Standard.
Such studies may be part of a manufacturer's quality system.
This International Standard contains only those requirements that are specific to centrifugal blood
pumps. Nonspecific requirements are covered by references to other International Standards
listed in the normative references section.
ISO/DIS 18424:xxxx
ISO/DIS 18424:xxxx
DRAFT INTERNATIONAL STANDARD ISO/DIS 18242:xxxx
Cardiovascular implants and extracorporeal systems —
Centrifugal Blood Pumps
1 Scope
This International Standard 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 International Standard does not apply to:
- centrifugal pumps used as ventricular assist devices;
- other components of extracorporeal circuits (e.g., blood tubing, pump console/driver);
.
2 Normative references
The following referenced documents are indispensible for the application of this document. For
dated references, only the most recent 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
ISO 10993-4, Biological evaluation of medical devices-Part4: 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 11658, Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface
modifications for extracorporeal perfusion systems
ISO/DIS 18424:xxxx
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
ASTM F1830, Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
centrifugal blood pump
extracorporeal device designed to produce rotational flow by means of radial force
3.2
blood pathway
paths of the pump containing blood during intended clinical use
3.3 operating variables
settings of controls that affect the function of the device
3.4 blood cell damage
loss or destruction of cellular components of the blood
3.5 platelet reduction
percentage reduction of platelets contained in a circuit incorporating a centrifugal pump as a
function of time
3.6 plasma-free hemoglobin level
concentration of plasma-free hemoglobin in a circuit incorporating a pump, as a function of time
3.6.1
normalized Index of Hemolysis
NIH
grams of plasma-free hemoglobin released after pumping 100 l of blood
3.7 white blood cell reduction
percentage reduction of white blood cells contained in a circuit incorporating a centrifugal pump
as a function of time
3.8 blood analogue
test solution which simulates blood viscosity between 2 cP to 3,5 cP
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in
accordance with 5.2.1.
ISO/DIS 18424:xxxx
4.1.2 Biocompatibility
All parts of the blood pathway shall be biocompatible with respect to their intended use.
Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
When determined in accordance with 5.3.1., the blood pathway shall not leak.
4.2.2 Prime volumes
When determined in accordance with 5.3.2, the volume of the blood pathway shall be within the
tolerances specified by the manufacturer (see 6.3).
4.2.3 Connector integrity
When determined in accordance with 5.3.3, the inlet and outlet ports shall allow a secure
connection.
NOTE Connectors of a type that allow connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5
mm or 12,7 mm, or a type that complies with ISO 7199.
4.3 Performance characteristics
4.3.1 Hydraulic Performance
When determined in accordance with 5.4.1, the flow rates, pressure and revolutions per minute
(rpm) shall be within the range of values specified by the manufacturer (see 6.3).
4.3.2 Blood cell damage
4.3.2.1 Plasma-free hemoglobin
When determined in accordance with 5.4.2, the rate of generation of plasma-free hemoglobin
shall be within the range of values specified by the manufacturer.
NOTE Testing performed at the maximum rated flow specified by the manufacturer and using an appropriate
circuit blood volume, is one way to comply with this requirement.
4.3.2.2 Platelet reduction
When determined in accordance with 5.4.2, the percentage reduction of platelets shall be within
the range of values specified by the manufacturer.
4.3.2.3 White blood cell reduction
When determined in accordance with 5.4.2, the percentage reduction of white blood cells shall be
within the range of values specified by the manufacturer.
4.3.3 Bearing durability
ISO/DIS 18424:xxxx
When determined in accordance with 5.4.4, the bearing shall remain functional over the duration
of the testing specified by the manufacturer, unless the device is bearingless.
4.3.4 Shelf life
When tested in accordance with 5.4.4, test results shall demonstrate the rated shelf life, as
specified by the manufacturer.
5 Tests and measurements to determine compliance with this International
Standard
5.1 General
5.1.1 Tests and measurements
Tests and measurements shall be performed with the device under test prepared according to the
manufacturer's instructions for intended clinical use and in accordance with the manufacturer’s
specified test methodology.
5.1.2 Operating variables
Operating variables shall be those specified by the manufacturer for intended clinical use, unless
otherwise specified.
5.1.3 Temperature
The temperature of the test liquid(s) shall be representative of a range of the intended
temperatures during clinical use of the device (e.g., hypothermic, normothermic, and/or
hyperthermic). Tests should be performed at multiple temperatures over the range of the
intended clinical use, or justification for testing at a single temperature should be provided (e.g.,
why this temperature is representative of the worst case condition).
5.1.4 Relationship between variables
If the relationship between variables is non-linear, sufficient determinations shall be made to
permit valid interpolation between data points.
5.1.5 Procedures
The test or measurement procedures are to be regarded as reference procedures. Other
procedures can be accepted, provided that the alternative procedure has been shown to be of
comparable precision and reproducibility.
5.1.6 Driver/Console
The specific driver(s)/console(s) used for testing of the rotary pump shall be specifically identified
in the test procedure.
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
Compliance shall be verified by inspection of the manufacturer's documentation on sterili
...
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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
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.
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 te
...
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