ISO 23089-2:2021 手術用インプラント—脊椎インプラントの前臨床機械的評価と特定の要件—パート2：脊椎椎間体固定装置 | ページ 2

Foreword

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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.

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.

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.

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:

Bibliography