ISO 23089-2:2021

Implants for surgery - Pre-clinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices

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.

Titre manque — Partie 2: Titre manque

General Information

• Status: Published
• Publication Date: 27-May-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5/WG 2 - Spinal devices
• Current Stage: 6060 - International Standard published
• Start Date: 28-May-2021
• Due Date: 03-Jul-2021
• Completion Date: 28-May-2021

Overview

ISO 23089-2:2021 is an international standard developed by ISO that defines the pre-clinical mechanical assessment requirements for spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis surgeries. Published in 2021, this standard is part 2 of the ISO 23089 series, focusing specifically on mechanical testing protocols and performance criteria to ensure the safety and reliability of IBFDs. The document outlines essential mechanical evaluations but does not cover all implant assessments, emphasizing the importance of device-specific considerations.

Key Topics

• Mechanical Load Considerations
  The standard addresses the primary mechanical loads experienced by IBFDs, including:

  • Axial compression loads, the main load these devices endure within the spine
  • Compression-shear loads caused during daily activities and spinal curvature forces
  • Torsional loads generated by axial rotation, especially relevant for cervical implants

• Test Methods
  ISO 23089-2 mandates rigorous mechanical tests to evaluate stiffness, yield strength, and fatigue endurance, referencing ASTM standards such as F2077 and F2267 for:

  • Static and fatigue axial compression testing
  • Compression-shear testing in posterior-to-anterior and other orientations
  • Torsion testing, with optional justification for lumbar devices
  • Subsidence resistance under axial compression

• Comparative Performance Benchmarks
  The standard provides optional acceptance criteria for cervical and lumbar IBFDs, derived from FDA-cleared devices, including stiffness, yield load, and dynamic performance parameters. These benchmarks aid manufacturers in establishing mechanical performance thresholds.

• Additional Mechanical Assessments
  Recognizing the diverse designs of IBFDs, the document encourages further tests including:

  • Coating strength and abrasion resistance
  • Migration and expulsion risk assessments
  • Corrosion resistance, especially important for metallic implants with multiple contacting parts
  • Impact resilience simulating surgical impaction loads
  • Considerations for additive manufacturing variability and quality control

Applications

ISO 23089-2:2021 serves as a critical reference for medical device manufacturers, regulatory bodies, and testing laboratories involved in the development and evaluation of spinal intervertebral body fusion devices. By adhering to these standardized mechanical testing requirements, stakeholders can:

• Ensure the mechanical integrity and durability of IBFDs before clinical use
• Facilitate regulatory approvals and market clearance through adherence to recognized testing protocols
• Improve implant safety by identifying potential mechanical failure modes such as migration, subsidence, and fracture
• Optimize implant design by benchmarking performance data against established acceptance criteria
• Address emerging technologies like additive manufacturing with appropriate evaluation strategies

This standard supports the continuous improvement of spinal implants used in fusion surgeries, enhancing patient outcomes through robust mechanical validation.

Related Standards

• ISO 14630: Non-active surgical implants - General requirements
  Provides fundamental definitions and general requirements relevant to IBFDs and other surgical implants.

• ASTM F2077: Test Methods for Intervertebral Body Fusion Devices
  Details mechanical testing procedures for static and fatigue characterization of spinal implants.

• ASTM F2267: Measuring Load-Induced Subsidence of Intervertebral Body Fusion Devices
  Specifies testing methods to evaluate device subsidence resistance under axial compressive loads.

• ISO 17327-1: Implant surfaces - Coating characterization
  Guides coating strength and abrasion testing protocols which complement assessments in ISO 23089-2.

• ASTM F2129: Test method for corrosion assessment of implantable medical devices
  Relevant for evaluating corrosion susceptibility of metallic IBFDs.

By integrating ISO 23089-2 with these harmonized standards, manufacturers and testing facilities can establish a comprehensive mechanical evaluation framework for spinal fusion implants.

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Keywords: ISO 23089-2, spinal intervertebral body fusion devices, IBFD mechanical assessment, spinal implants standards, spinal arthrodesis, mechanical testing spinal implants, ASTM F2077, ASTM F2267, implant subsidence testing, spinal implant durability, coating characterization, implant migration risk, additive manufacturing spinal devices.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 23089-2
First edition
2021-05
Implants for surgery — Pre-
clinical mechanical assessment
of spinal implants and particular
requirements —
Part 2:
Spinal intervertebral body fusion
devices
Reference number
©
ISO 2021
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2021 – All rights reserved

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
Foreword
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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
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iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 5, Osteosynthesis and spinal devices.
A list of all parts in the ISO 23089 series can be found on the ISO website.
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.
iv © ISO 2021 – All rights reserved

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.
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).
— 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 unne
...