Implants for surgery -- Pre-clinical mechanical assessment of spinal implants and particular requirements

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Status
Published
Publication Date
27-May-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
22-Apr-2021
Completion Date
22-Apr-2021
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ISO/PRF 23089-2 - Implants for surgery -- Pre-clinical mechanical assessment of spinal implants and particular requirements
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INTERNATIONAL ISO
STANDARD 23089-2
First edition
Implants for surgery — Pre-
clinical mechanical assessment
of spinal implants and particular
requirements —
Part 2:
Spinal intervertebral body fusion
devices
PROOF/ÉPREUVE
Reference number
ISO 23089-2:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 23089-2:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
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Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
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ISO 23089-2:2021(E)
Contents Page

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

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

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

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

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

4 Mechanical requirements ........................................................................................................................................................................... 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Test methods ............................................................................................................................................................................................. 2

4.3 Comparative mechanical performance data .................................................................................................................. 2

4.4 Other considerations ......................................................................................................................................................................... 4

4.4.1 Coating characterization ........................................................................................................................................... 4

4.4.2 Migration/expulsion ..................................................................................................................................................... 4

4.4.3 Corrosion ................................................................................................................................................................................ 4

4.4.4 Impaction ............................................................................................................................................................................... 4

4.4.5 Additive manufacturing ............................................................................................................................................. 4

Bibliography ................................................................................................................................................................................................................................ 5

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
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ISO 23089-2:2021(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 of the voluntary nature of standards, 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 www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

SC 5, Osteosynthesis and spinal devices.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 23089-2:2021(E)
Introduction

Spinal intervertebral body fusion devices (IBFDs) are used in the treatment of various spinal

pathologies. IBFDs are intended to be placed in between two adjacent vertebral bodies after removal

of the interverbal disc to maintain the disc height and provide mechanical stability to the spine until

fusion (arthrodesis) occurs.

This document intends to establish a minimum battery of performance testing necessary during the

development of IBFDs. However, certain IBFDs have design features that warrant additional evaluations,

and the user of this document is advised to consider if additional tests/evaluations are necessary.

Additional assessments can be necessary to assess technical aspects of the device not completely covered

by the assessments outlined in this document such as, but not limited to, coating characterization,

impact testing, expulsion testing and additive manufacturing process validations.

© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
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INTERNATIONAL STANDARD ISO 23089-2:2021(E)
Implants for surgery — Pre-clinical mechanical assessment
of spinal implants and particular requirements —
Part 2:
Spinal intervertebral body fusion devices
1 Scope

This document specifies requirements for the mechanical assessment of spinal intervertebral body

fusion devices (IBFDs) used in spinal arthrodesis procedures.

This document focuses on mechanical requirements and does not intend to cover all assessments for

various types of IBFDs.
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 14630, Non-active surgical implants — General requirements
ASTM F2077, Test Methods For Intervertebral Body Fusion Devices

ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion

Device Under Static Axial Compression
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14630 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 https:// www .electropedia .org/
4 Mechanical requirements
4.1 General

IBFDs function as load bearing implants that are subjected to the mechanical loads associated with the

region of the spine in which the device is implanted. IBDF mechanical assessments shall consider the

device’s performance under the following loading modes:

— axial compression: axial compression loads are the primary mechanical load to which IBFDs are

subjected in the body.

— compression-shear: IBFDs experience shear loads generated in the spine during activities of daily

life and due to compression loads being applied across spinal curvatures (e.g. lumbar and cervical

lordosis).
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 1
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ISO 23089-2:2021(E)

— torsion: torsional moments are generated in the spine during activities of daily life (torsional

properties are most commonly assessed for devices intended to be implanted in the cervical spine).

In situations where the evaluation of an IBFD under the loading modes prescribed in this clause is

deemed unnecessary, the user of this document choosing not to carry out the evaluation shall provide

justification for this decision.
4.2 Test methods

The intervertebral body fusion device shall be evaluated using the following test methods unless

adequate justification is provided that a particular assessment is unnecessary.
— Axial compression testi
...

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