Work Item
ASTM WK61694

New Specification for Wrought Nickel-Titanium Shape Memory Alloy Wire for Medical Devices and Surgical Implants

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

medical devices; metals (for surgical implant); nickel-titanium alloys; niti; nitinol; shape memory alloy; surgical implants; wire

Rationale

No standard specification defining requirements for nickel-titanium shape memory alloy wire for use in medical devices and surgical implants exists. This standard specification will be used by medical device companies, metal wire producers and government agencies to ensure consistent product and assist with quality control.

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

Details

Developed by Subcommittee: F04.12

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 01-04-2018

Technical Contact: Steven Walak

Item: 001

Ballot: F04.12 (20-02)

Status: Will Reballot Item