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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Status
Published
Publication Date
14-Aug-2016
Current Stage
9060 - Close of review
Start Date
03-Dec-2021
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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 18242:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
ISO 18242:2016(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

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
---------------------- Page: 2 ----------------------
ISO 18242:2016(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 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

© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 18242:2016(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.
iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 18242:2016(E)
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.

© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
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
...

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
---------------------- Page: 1 ----------------------
ISO/DIS 18242:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 2 ----------------------
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 2015 – All rights reserved. iii
---------------------- Page: 3 ----------------------
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 2015 – All rights reserved. iv
---------------------- Page: 4 ----------------------
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 2015 – All rights reserved. v
---------------------- Page: 5 ----------------------
ISO/DIS 18424:xxxx
© ISO 2015 – All rights reserved. 0
---------------------- Page: 6 ----------------------
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 2015 – All rights reserved. 1
---------------------- Page: 7 ----------------------
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 2015 – All rights reserved. 2
---------------------- Page: 8 ----------------------
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 accor
...

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