YY/T 1926.2-2024Spinal implants - Pre-clinical mechanical assessment and particular requirements - Parts 2: Spinal intervertebral body fusion devices (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is modified to adopt ISO 23089-2:2021 "Preclinical mechanical properties evaluation and special requirements for surgical implants Part 2: Vertebral Inter-fusion device.

The technical differences between this document and ISO 23089-2:2021 and their reasons are as follows.

--- Regarding normative references, this document has been adjusted with technical differences to adapt to my country's technical conditions.

The situation is reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.

- Replaced ISO 14630 with YY/T 0640 which is equivalent to the international standard;

- YY/T 0959 replaced ASTMF2077;

- YY/T 0960 replaced ASTMF2267.

The following editorial changes were made to this document.

--- Changed the name of the standard to replace "surgical implants" with "spinal implants" to clarify the specific application areas of the standard;

--- Added "This document is applicable to the evaluation of spinal intervertebral fusion devices used in spinal fusion surgery" to improve the scope of application of this document Limited (see Chapter 1);

--- The abbreviation for interbody fusion devices (IBFDs) (see Chapter 3) has been deleted to avoid confusion;

--- Changed the explanation of the data source in Table 1 as a note (see 4.3);

--- Deleted "or when the local regulatory authority does not accept the first two options" in 4.3c).

Introduction

Spinal interbody fusion cages are used to treat various spinal lesions. After the intervertebral disc is removed, the interbody fusion cage is implanted between adjacent vertebrae to maintain Increase intervertebral height and provide mechanical stability to the spine during spinal fusion.

The purpose of this document is to establish the minimum requirements for performance testing necessary during the development of interbody fusion devices.

Users are concerned about interbody fusion devices with design features that require additional testing (evaluation).

It may be necessary to conduct additional evaluation of aspects of cage technology not fully covered in this document, such as, but not limited to. coating properties;

energy, impact testing, breakout testing and additive manufacturing process validation.

Preclinical evaluation of mechanical properties of spinal implants and Particular requirements - Part 2: Interbody fusion cages

1 Scope

This document specifies specific requirements for the evaluation of the mechanical properties of spinal interbody fusion cages used in spinal fusion procedures.

This document applies to the evaluation of spinal interbody fusion devices used in spinal fusion procedures.

This document focuses mainly on mechanical requirements and does not include all evaluation contents of different types of spinal interbody fusion devices.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2016, ISO 14630:2012, IDT) YY/T 0959 Test method for mechanical properties of spinal implants and intervertebral fusion devices YY/T 0960 Test method for static axial compression sinkage of spinal implant intervertebral fusion cage

3 Terms and definitions

The terms and definitions defined in YY/T 0640 apply to this document.

The URLs of ISO and IEC databases for standardization are as follows.

4 Mechanical requirements