Work Item
ASTM WK76260

New Test Methods for Sacroiliac Joint Fusion Devices

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

dynamic test methods; sacroiliac joint (SIJ) fusion device; SIJ implants; static test methods; sacroiliac screw

Rationale

No standardized test method is in place for sacroiliac joint fusion devices. The medical device industry along with the FDA are in need of standardized testing for the evaluation of the mechanical performance of SIJ fusion devices.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: F04.25

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 03-15-2021

Technical Contact: Nathan Wright

Item: 001

Ballot: F04.25 (21-01)

Status: Will Reballot Item

Item: 001

Ballot: F04.25 (21-03)

Status: Will Reballot Item

Item: 012

Ballot: F04 (22-02)

Status: In Balloting