Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

Implants cardiovasculaires et systèmes extracorporels — Revêtements pour l'équipement au contact du sang

General Information

Status
Published
Publication Date
10-May-2012
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2017
Completion Date
15-Jul-2022
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ISO 11658:2012 - Cardiovascular implants and extracorporeal systems -- Blood/tissue contact surface modifications for extracorporeal perfusion systems
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INTERNATIONAL ISO
STANDARD 11658
First edition
2012-05-15
Cardiovascular implants and
extracorporeal systems — Blood/
tissue contact surface modifications for
extracorporeal perfusion systems
Implants cardiovasculaires et systèmes extracorporels — Revêtements
pour l’équipement au contact du sang
Reference number
ISO 11658:2012(E)
ISO 2012
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ISO 11658:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s

member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2012 – All rights reserved
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ISO 11658:2012(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 11658 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,

Cardiovascular implants and extracorporeal systems.
© ISO 2012 – All rights reserved iii
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ISO 11658:2012(E)
Introduction

This International Standard is intended to ensure that devices that have surface modified blood-contacting

surfaces are tested for their safety, integrity and function, and that extracorporeal device characteristics are

appropriately disclosed when labelling the device. This International Standard also includes minimum reporting

requirements, which will allow the user to compare properties in a standard way.

This International Standard therefore contains recommended procedures to be used for evaluation of modified

surfaces. The requirements for determination of the surface coverage, leaching and biological activity, if

claimed, of the surface modification are addressed, although limits for these requirements are not specified.

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.

Additional requirements are covered by references to other International Standards listed in the normative references.

iv © ISO 2012 – All rights reserved
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INTERNATIONAL STANDARD ISO 11658:2012(E)
Cardiovascular implants and extracorporeal systems —
Blood/tissue contact surface modifications for extracorporeal
perfusion systems
1 Scope

This International Standard specifies requirements for the physical, biological and performance testing of

biocompatible modifications on extracorporeal devices. This International Standard is applicable to components

of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have

modifications on the blood and tissue-contacting surfaces of the device.

The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If

hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

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 7199, Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

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 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 15674, Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems

(with/without filter) and soft venous reservoir bags

ISO 15675, Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial

blood line filters

ISO 15676, Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for

cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

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 2012 – All rights reserved 1
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ISO 11658:2012(E)
3.1
surface modification

modification that can be biologically derived or non-biologically derived and can be applied to blood-contacting

surfaces or additives incorporated into a material as part of the manufacturing process

3.2
coverage

extent to which a surface modification applied to a blood contact device effectively covers the blood or tissue-

contacting surface of the device
3.3
leaching

extent to which a surface modification applied to the surface of a blood contact device may elute from the

surface of the device directly contacting the patient or into the fluid stream which in turn contacts the patient

3.4
bioactivity

quantification of any biological activity that a surface modification applied to the surface of a blood contact

device imparts to the blood or tissues to which it is exposed
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.

4.1.2 Biocompatibility

Parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be

verified in accordance with 5.2.2.
4.1.3 Biological activity

If any claims of biological activity are made by the manufacturer, then quantification of such claims shall be

verified by the manufacturer in accordance with 5.2.3.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
When tested in accordance with 5.3.1, the blood pathway shall not leak.
4.2.2 Blood pathway coverage

The surfaces which are covered by the surface modification shall be verified by the manufacturer in

accordance with 5.3.2.
4.2.3 Surface modification integrity

The integrity of the surface modification shall be verified by the manufacturer in accordance with 5.3.3.

2 © ISO 2012 – All rights reserved
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ISO 11658:2012(E)
4.3 Performance characteristics
4.3.1 Blood cell damage

When determined in accordance with 5.4.1, the percentage change (positive or negative) of plasma-free

haemoglobin, platelets and white blood cells shall be within the range of values specified by the manufacturer.

4.3.2 General performance

When determined in accordance with 5.4.2, the ability of the device to perform its intended function with the

biocompatible surface modification in place shall be verified by the manufacturer.

4.3.3 Shelf life

When tested in accordance with 5.4.3, test results shall demonstrate the rated shelf life.

5 Tests
5.1 General

5.1.1 Tests and measurements shall be performed with the device in its terminally sterilized form, and prepared

according to the manufacturer’s instructions for intended clinical use.
5.1.2 Operating variables shall be those specified by
...

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