ISO 15676:2016
(Main)Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile". It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
Implants cardiovasculaires et organes artificiels — Exigences pour les paquets de tubes à usage unique pour pontage cardiopulmonaire et oxygénation des membranes extracorporelles
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INTERNATIONAL ISO
STANDARD 15676
Second edition
2016-08-15
Cardiovascular implants and artificial
organs — Requirements for single-
use tubing packs for cardiopulmonary
bypass and extracorporeal membrane
oxygenation (ECMO)
Implants cardiovasculaires et organes artificiels — Exigences pour les
paquets de tubes à usage unique pour pontage cardiopulmonaire et
oxygénation des membranes extracorporelles
Reference number
ISO 15676:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO 15676:2016(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 15676:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
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 General. 3
4.2.2 Dimensions . 3
4.2.3 Material properties . 3
4.3 Performance characteristics. 3
4.3.1 Priming volume . 3
4.3.2 Life to failure testing . 4
4.3.3 Spallation . 4
4.3.4 Shelf life . 4
5 Tests and measurements . 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 . 5
5.3.1 Blood pathway integrity . 5
5.3.2 Connections . 5
5.3.3 Tubing material property testing . 5
5.4 Performance characteristics. 5
5.4.1 Tubing life . 5
5.4.2 Spallation in tubing used in roller pumps . 5
5.4.3 Shelf life . 6
6 Information supplied by the manufacturer . 6
6.1 Information on the tubing pack . 6
6.1.1 Information on the unit container . 6
6.1.2 Information on the shipping container . 6
6.2 Information on the accompanying documents . 7
6.3 Information in the accompanying documents in a prominent form . 7
6.4 Information to be provided by manufacturer upon request . 7
7 Packaging . 7
Bibliography . 8
© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 15676:2016(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.
This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically
revised.
iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 15676:2016(E)
Introduction
The intent of this document is to ensure that medical grade tubing in single-use tubing packs for the
transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal
membrane oxygenation (ECMO) is adequately tested for both safety and function. The user commonly
provides the specifications for the tubing pack. Furthermore, the purpose of this document is to ensure
that the tubing pack characteristics be appropriately disclosed in the labelling and manufacturing
information package. Tubing performance characteristics are specifically addressed within the context
of this document as a component part of a single-use tubing pack.
This document therefore contains recommended procedures to evaluate such medical grade tubing
intended for use during CPB procedures and ECMO. Test procedures to determine the material
characteristics, the useful life of the tubing when used in a roller pump, and cleanliness are described.
The limits for these characteristics are not specified.
This document also includes minimum reporting requirements. Ready identification of the performance
characteristics should assist the user in the selection of such medical grade tubing for the procedure
appropriate to the patient and procedure. This information may be useful in a clinic’s quality control
process that aims to improve the safety of CPB and ECMO procedures.
This document makes reference to other International Standards, which references methods for the
determination of characteristics common to medical devices.
Requirements for animal and clinical studies are not included in this document. Such studies, however,
may be part of a manufacturer’s quality system.
This document contains only those requirements that are specific to such medical grade tubing for
use during CPB and ECMO. Non-specific requirements are covered by reference to other International
Standards listed in the Normative References section.
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 15676:2016(E)
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
1 Scope
This document specifies requirements for single-use tubing packs for cardiopulmonary bypass and
extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing
intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO),
but specific requirements and tests are included for tubing intended for use with peristaltic pumps
during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The
sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as
“sterile”.
This document is applicable only to the tubing aspects for multifunctional systems that may have
integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers,
blood pumps, etc.
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 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle
and crescent test pieces
ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 9352, Plastics — Determination of resistance to wear by abrasive wheels
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 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
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 medical devices
ISO 11137-2, Sterilization of health care
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15676
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-05-08 2015-08-08
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
Implants cardiovasculaires et organes artificiels — Exigences pour les paquets de tubes à usage unique
pour pontage cardiopulmonaire et oxygénation des membranes extracorporelles
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 15676:2015(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 15676:2015(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 15676:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
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 General. 3
4.2.2 Dimensions . 3
4.2.3 Material properties . 3
4.3 Performance characteristics. 3
4.3.1 Priming volume . 3
4.3.2 Life to failure testing . 4
4.3.3 Spallation . 4
4.3.4 Shelf life . 4
5 Tests and measurements . 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 . 5
5.3.1 Determination of blood pathway integrity . 5
5.3.2 Connections . 5
5.3.3 Tubing material property testing . 5
5.4 Performance characteristics. 5
5.4.1 Determination of tubing life . 5
5.4.2 Spallation in tubing used in roller pumps . 5
5.4.3 Shelf life . 6
6 Information supplied by the manufacturer . 6
6.1 Information to be given on the tubing pack . 6
6.1.1 Information to be given on the unit container . 6
6.1.2 Information to be given on the shipping container . 6
6.2 Information to be given on the accompanying documents . 7
6.3 Information to be given in the accompanying documents in a prominent form . 7
6.4 Information to be provided by manufacturer upon request . 7
7 Packaging . 7
Bibliography . 8
© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 15676:2015(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.
This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically
revised.
iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 15676:2015(E)
Introduction
The intent of this International Standard is to ensure that medical grade tubing in single-use tubing
packs for the transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and
extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and function.
The user commonly provides the specifications for the tubing pack. Furthermore, the purpose of this
International Standard is to ensure that the tubing pack characteristics be appropriately disclosed in the
labelling and manufacturing information package. Tubing performance characteristics are specifically
addressed within the context of this International Standard as a component part of a single-use tubing
pack.
This International Standard therefore contains recommended procedures to evaluate such medical
grade tubing intended for use during CPB procedures and ECMO. Test procedures to determine the
material characteristics, the useful life of the tubing when used in a roller pump, and cleanliness are
described. The limits for these characteristics are not specified.
This International Standard also includes minimum reporting requirements. Ready identification of the
performance characteristics should assist the user in the selection of such medical grade tubing for the
procedure appropriate to the patient and procedure. This information may be useful in a clinic’s quality
control process that aims to improve the safety of CPB and ECMO procedures.
This International Standard makes reference to other International Standards, which references
methods for the determination of characteristics common to medical devices.
Requirements for animal and clinical studies are not included in this International Standard. Such
studies, however, may be part of a manufacturer’s quality system.
This International Standard contains only those requirements that are specific to such medical grade
tubing for use during CPB and ECMO. Non-specific requirements are covered by reference to other
International Standards listed in the Normative References section.
© ISO 2015 – All rights reserved v
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 15676:2015(E)
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
1 Scope
This International Standard specifies requirements for single-use tubing packs for cardiopulmonary
bypass and extracorporeal membrane oxygenation (ECMO). This International Standard is applicable
to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane
oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with
peristaltic pumps during (short- term, i.e. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO
procedures. The sterility and non- pyrogenicity provisions of this International Standard are applicable
to tubing packs labelled as “sterile”.
This International Standard is applicable only to the tubing aspects for multifunctional systems that
may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters,
defoamers, blood pumps, etc.
2 Normative references
The following referenced documents are indispensable for the application 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 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle
and crescent test pieces
ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 868, Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore
hardness)
ISO 9352, Plastics — Determination of resistance to wear by abrasive wheels
ISO 1183−1, Plastics — Methods for determining the density of non-cellular plastics — Part 1: Immersion
method, liquid pyknometer method and
...
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