Balloting minor revisions to add clause 4.3. This clauses have been systematically applied to the standards in F04.21 to address surgical implant material types and specifications.
"4.3 Metallic Implantable Strands and Cables shall be fabricated from a (metallic) material intended for surgical implant applications. In addition, biocompatibility of the material and final, finished device shall be established for the intended application. Materials should be chosen based on the design requirements of the particular device. ASTM committee F04 on Medical and Surgical Materials and Devices maintains a number of specifications for materials that are suitable for surgical implant and instrument applications."
Developed by Subcommittee: F04.21
Staff Manager: Kathleen Chalfin
Date Initiated: 07-07-2022
Technical Contact: Christopher Ferreira
Ballot: F04 (22-05)
Status: Negative Votes Need Resolution