ISO 15675:2016

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters

ISO 15675:2016 specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.

Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio-pulmonaire — Filtres en ligne pour sang artériel

General Information

• Status: Published
• Publication Date: 14-Aug-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2/WG 4 - Blood gas exchangers
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 26-May-2023

Relations

• Amended By: ISO 15675:2016/Amd 1:2020 - Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors
• Effective Date: 25-Apr-2020
• Revises: ISO 15675:2009 - Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
• Effective Date: 11-Oct-2014
• Consolidated By: ISO 22744-2:2020 - Textiles and textile products — Determination of organotin compounds — Part 2: Direct method using liquid chromatography
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 15675
Third edition
2016-08-15
Cardiovascular implants and artificial
organs — Cardiopulmonary bypass
systems — Arterial blood line filters
Implants cardiovasculaires et organes artificiels — Systèmes de
pontage cardio-pulmonaire — Filtres en ligne pour sang artériel
Reference number
ISO 15675:2016(E)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO 15675:2016(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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 15675:2016(E)

Contents Page
Foreword .iv
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 Blood volume . 3
4.2.3 Connectors . 3
4.3 Performance characteristics. 3
4.3.1 Blood cell damage . 3
4.3.2 Filtration efficiency . . 3
4.3.3 Flow rate capacity . 4
4.3.4 Shelf life . 4
4.3.5 Air-handling capability . 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 (sterile final assembly) . 4
5.3.2 Blood volume . 5
5.3.3 Connectors . 5
5.4 Performance characteristics. 5
5.4.1 Blood cell damage . 5
5.4.2 Filtration efficiency . . 6
5.4.3 Filter flow rate . 6
5.4.4 Shelf life . 6
5.4.5 Air-handling capability . 6
6 Information supplied by the manufacturer . 7
6.1 Information on the arterial blood line filter . 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 15675:2016(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 third edition cancels and replaces the second edition (ISO 15675:2009), which has been technically
revised.
iv © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 15675:2016(E)
Cardiovascular implants and artificial organs —
Cardiopulmonary bypass systems — Arterial blood line
filters
1 Scope
This document specifies requirements for sterile, single-use, arterial blood line filters intended to filter
and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from
the blood of humans during cardiopulmonary bypass surgery.
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, 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 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 http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
© ISO 2016 – All rights reserved 1

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ISO 15675:2016(E)

3.1
arterial blood line filter
accessory device used as part of the cardiopulmonary bypass system in the arterial blood return line
for filtering particles such as blood clots, debris and gas emboli from the blood
3.2
blood pathway
paths of the arterial blood line filter (3.1) containing blood during its intended clinical use
3.3
blood cell damage
loss or destruction of cellular components of the blood components
3.4
platelet reduction
percentage reduction of platelets contained in a circuit, as a function of time
3.5
plasma-free haemoglobin level
difference between the concentration of plasma-free haemoglobin in a circuit, as a function of time
3.5.1
normalized index of hemolysis
NIH
grams o
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15675
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-05-08 2015-08-08
Cardiovascular implants and artificial organs —
Cardiopulmonary bypass systems — Arterial blood line
filters
Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio-pulmonaire — Filtres en
ligne pour sang artériel
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 15675:2015(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 15675:2015(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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 15675:2015(E)

Contents Page
Foreword .iv
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 Blood volume . 3
4.2.3 Connectors . 3
4.3 Performance characteristics. 3
4.3.1 Blood cell damage . 3
4.3.2 Filtration efficiency . . 3
4.3.3 Flow rate capacity . 3
4.3.4 Shelf life . 3
4.3.5 Air-handling capability . 3
5 Tests and measurements to determine compliance with this International Standard .3
5.1 General . 3
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 Determination of blood pathway integrity (sterile final assembly) . 4
5.3.2 Test liquid . . . 4
5.3.3 Connectors . 4
5.4 Performance characteristics. 4
5.4.1 Blood cell damage . 4
5.4.2 Filtration efficiency . . 5
5.4.3 Filter flow rate . 5
5.4.4 Shelf life or expiry date . . 6
5.4.5 Air-handling capability . 6
6 Information supplied by the manufacturer . 6
6.1 Information to be given on the arterial blood line filter . 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 . 8
7 Packaging . 8
Bibliography . 9
© ISO 2015 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/DIS 15675:2015(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 third edition cancels and replaces the second edition (ISO 15674:2009), which has been technically
revised.
This third edition cancels and replaces the second edition (ISO 15675:2009), which has been technically
revised.
iv © ISO 2015 – All rights reserved

---------------------- Page: 4 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 15675:2015(E)
Cardiovascular implants and artificial organs —
Cardiopulmonary bypass systems — Arterial blood line
filters
1 Scope
This International Standard specifies requirements for sterile, single-use, arterial blood line filters
intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and
gaseous material from the blood of humans during cardiopulmonary bypass surgery.
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 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, 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 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
...