Standardization News

ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing two new proposed standards that will be used in the field of arthroplasty. Arthroplasties are surgical procedures that resurface, remodel, rebuild or replace arthritic or dysfunctional sites of the body, with optimal goals being pain alleviation, a return to full range of motion, improvement in mobility and muscle strengthening.

The proposed standards, WK28231, Specification for Total Elbow Replacement Prosthesis, and WK28559, Guide for Assessment of Metal-on-Metal Total Hip Replacement Devices, are being developed under the jurisdiction of Subcommittee F04.22 on Arthroplasty.

According to Brian Kincaid, senior research engineer, Zimmer Inc., the increased use of arthroplasty for the upper extremities, combined with a shortage of international standards for such devices, has created the need for ASTM WK28231 on total elbow devices. "The proposed new standard will provide a set of guidelines that includes types of materials, design philosophies, surface finishes and so forth that have worked well in the past," says Kincaid.

The second proposed standard, ASTM WK28559, covers general test methods for the chemical, biocompatibility, mechanical and preclinical assessments of implantable devices with metal-on-metal articulation intended to replace a hip joint. According to Leslie Gilbertson, principal engineer, L. Gilbertson Consulting LLC, WK28559 will provide manufacturers with an understanding of what the tests do and help them meet current and future regulatory requirements.

Subcommittee F04.22 welcomes participation from all interested parties and particularly members of the orthopedic surgical community.

CONTACT Technical Information: Leslie Gilbertson, L. Gilbertson Consulting LLC • Warsaw, Ind. • Phone: 574-307-1532 • E-mail: l.gilbertson@lgilbertsonconsulting.com O ASTM Staff: Daniel Schultz • Phone: 610-832-9716 • E-mail: dschultz@astm.org O Upcoming Meeting: Nov. 16-19 • November Committee Week • San Antonio, Texas