Standards

ASTM F560 - 08


ASTM F560 - 08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)


Active Standard ASTM F560 Developed by Subcommittee: F04.12 |Book of Standards Volume: 13.01

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ASTM F560

Abstract

This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire for the manufacture of surgical implants. Material covered by this specification shall be made from vacuum-arc melted or electron-beam melted ingots (UNS R05200) or powder-metallurgy consolidated (UNS R05400) unalloyed tantalum. Tantalum mill products shall be formed with the conventional extrusion, forming, swaging, rolling, and drawing equipment, and may be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished. Flat mill products shall be supplied in the cold-worked, cold-worked and stress-relieved, or annealed condition while rod and wire products shall be supplied in the annealed or cold worked condition. The material shall conform to the chemical composition requirements prescribed for: carbon, oxygen, nitrogen, hydrogen, niobium, iron, titanium, tungsten, molybdenum, silicon, nickel, and tantalum, as determined by ingot chemical analysis. The mechanical property requirements specified includes: ultimate tensile strength, yield strength, and elongation. Tension test shall be performed at least once for each lot of the material.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. Scope

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire used in the manufacture of surgical implants.

1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E8 Test Methods for Tension Testing of Metallic Materials

E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

American Society for Quality Control Standard

ASQC1 Specifications of General Requirements for a Quality Program

ISO Standard

ISO6892MetallicMater Tensile Testing at Ambient Temperature



Keywords

metals (for surgical implants); orthopaedic medical devices; tantalum; Metallic surgical implant materials--specifications; Orthopaedic medical devices--specifications; Surgical implants--specifications; Tantalum (Ta)/tantalum alloys--specifications; UNS R05200 (Ta, unalloyed, cast); UNS R05400 (Ta, unalloyed, sintered);



ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)



DOI: 10.1520/F0560-08

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