ISO 15676:2016

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.
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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
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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ISO/DIS 15676:2015(E)

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© ISO 2015
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ii © ISO 2015 – All rights reserved

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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

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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.
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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

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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
...