ASTM WK61694

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

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    Developed by Subcommittee: F04.12 | Committee F04 | Contact Staff Manager



    WK61694

    1. Scope

    This specification covers the requirements for wrought nickel-titanium shape memory alloy wire, nominally 54.5 to 57.0 mass/mass (weight) % nickel, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade wire from the raw material and mill product forms covered in Specification F2063.


    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.

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    Work Item Status

    Date Initiated:
    01-04-2018

    Technical Contact:
    Steven Walak

    Status:
    Draft Under Development