Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps

ISO 18241:2016 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.

Implants cardiovasculaires et systèmes extracorporels — Systèmes de pontage cardiopulmonaire — Pièges à bulles veineuses

General Information

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 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
---------------------- Page: 1 ----------------------
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

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 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

© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
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.
iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
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.
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
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/
© ISO 2016 – All rights reserved 1
---------------------- Page: 6 ----------------------
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
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 18241
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-05-08 2015-08-08
Cardiovascular implants and extracorporeal systems —
Cardiopulmonary bypass systems — Venous bubble traps
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 18241:2015(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 18241:2015(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 18241:2015(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Biological characteristics ............................................................................................................................................................... 2

4.1.1 Sterility and non-pyrogenicity ............................................................................................................................. 2

4.1.2 Biocompatibility ............................................................................................................................................................... 2

4.2 Physical characteristics ................................................................................................................................................................... 2

4.2.1 Blood pathway integrity ............................................................................................................................................ 2

4.2.2 Prime volume ...................................................................................................................................................................... 2

4.2.3 Connectors ............................................................................................................................................................................ 2

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 ................................................................................................................................................................................... 3

5 Tests and measurements to determine compliance with this International Standard ..............3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Biological characteristics ............................................................................................................................................................... 3

5.2.1 Sterility and non-pyrogenicity ............................................................................................................................. 3

5.2.2 Biocompatibility ............................................................................................................................................................... 3

5.3 Physical characteristics ................................................................................................................................................................... 4

5.3.1 Determination of blood pathway integrity ................................................................................................ 4

5.3.2 Prime volume ...................................................................................................................................................................... 4

5.3.3 Connectors ............................................................................................................................................................................ 4

5.4 Performance characteristics........................................................................................................................................................ 4

5.4.1 Blood cell damage ........................................................................................................................................................... 4

5.4.2 Air removal efficiency .................................................................................................................................................. 5

5.4.3 Venous bubble trap flow rate and pressure drop ................................................................................ 6

5.4.4 Shelf life or expiry date ........................................................................................................................................... .... 6

6 Information supplied by the manufacturer ............................................................................................................................. 6

6.1 Information to be given on the venous bubble trap ................................................................................................ 6

6.2 Information to be given on the packaging ....................................................................................................................... 6

6.2.1 Information to be given on the unit container ....................................................................................... 6

6.2.2 Information to be given on the shipping container ........................................................................... 7

6.3 Information to be given in the accompanying documents ................................................................................ 7

6.4 Information to be given in the accompanying documents in a prominent form ........................... 7

7 Packaging ..................................................................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 18241:2015(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. 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. 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 WTO principles in the Technical Barriers

to Trade (TBT), see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,

Cardiovascular implants and extracorporeal systems.
iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 18241:2015(E)
Introduction

This International Standard 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 labelling the device.

This International Standard 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 International Standard 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 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 venous bubble traps.

Nonspecific requirements are covered by references to other International Standards listed in the

normative references section.”
© ISO 2015 – All rights reserved v
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 18241:2015(E)
Cardiovascular implants and extracorporeal systems —
Cardiopulmonary bypass systems — Venous bubble traps
1 Scope

This International Standard 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, in whole or in part, are normatively referenced in this document and are

indispensable for its application. 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 10993-7, 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 b
...

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