Work Item
ASTM WK70031

New Practice for Clinically Relevant Preconditioning of Polymer-based Bearing Materials for Non-Clinical Testing of Joint Arthroplasty 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

joint prosthesis materials; joint prostheses; joint replacements; preconditioning; pre-conditioning; accelerated aging; aging; oxidation; stability; UHMWPE; UHMW PE; ultra-high molecular weight polyethylene; crosslinked PE; XLPE; cross-linked polyethylene

Rationale

This work item was initially started by ASTM subcommittee F04.22 (Arthroplasty) in order to provide some much-needed direction and clarity around clinically relevant preconditioning processes (e.g., accelerated aging, etc.), and how they should be applied to non-clinical bench testing (e.g., static, fatigue, wear testing, etc) of joint arthroplasty devices. We are looking to collaborate across subcommittees to help with this task, and so we are reaching out to ask for your help as we strive to support our industry.

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

Details

Developed by Subcommittee: F04.22

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 09-25-2019

Technical Contact: Leah Guenther

Item: 000

Ballot:

Status: