ASTM WK19883

    Work Item: ASTM WK19883 - New Guide for Conducting and Evaluating Galvanic Corrosion Tests of Medical Implant Devices

    (What is a Work Item?)

    Developed by Subcommittee: F04.15 | Committee F04 | Contact Staff Manager



    1. Scope

    1.1 This guide covers conducting and evaluating galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact within a biomedical implant or when biomedical implants of different alloys are in contact with one another. It is a modified version of an established guide. 1.2 This guide covers the selection of materials, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in a simulated physiological electrolyte. Additional information on galvanic corrosion testing and examples of the conduct and evaluation of galvanic corrosion tests in electrolytes are given in Refs (1) through (x).

    While ASTM G71 provides a general guide for conducting and evaluating galvanic corrosion tests, it does not address the specific concerns relevant to performing such testing on small medical implant devices. Regulatory bodies require that device manufacturers demonstrate corrosion resistance of their devices. This standard will provide a guide as to how to assess galvanic interactions in devices of mixed alloy materials, or when multiple devices of different alloys are in contact.


    Keywords

    corrosion; dissimilar metals; galvanic corrosion; galvanic couple; zero resistance ammeter; biomedical implant devices

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

    Citing ASTM Standards
    Back to Top
    Work Item Status

    Date Initiated:
    05-09-2008

    Technical Contact:
    Shari Rosenbloom

    Item:
    003

    Ballot:
    F04 (13-06)

    Status:
    Ballot Item Approved as F3044-2014 and Pending Publication