Tantalum for Surgical Implants

Specifications and Standards

Surgical grade (medical grade) tantalum – i.e. tantalum used in medical devices, are specified in a number of standards like:

  • ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
  • ISO 13782: Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications.
  • BS 7252-13: Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications

where the British surgery standard BS 7252-13 is identical to the ISO 13782 standard.

The standards specify the chemical, mechanical, and metallurgical requirements for unalloyed tantalum used in orthopedic surgery or in the manufacture of implants. The material specification in the standards are substantially similar.

Surgical Grade Tantalum Base Forms

A number of  base forms are covered by the ASTM F560 standard.

ASTM F560 differentiates orthopedic grade tantalum products in the following way:

Tantalum plate are defined a flat product more than 0.1875 in. (4.7 mm) in thickness.
Tantalum sheet are flat products less than 0.1875 in. (4.7 mm) in thickness and more than 6 in. (152.4 mm) wide.
Tantalum strip is a flat product less than 0.1875 in. (4.7 mm) in thickness less than 6 (152.4 mm) in. wide.
Tantalum rod for surgery is defined as a material with a diameter between 0.125 to 2.5 in. (3.18 to 63.50 mm) supplied in straight lengths (round, hexagonal, or octagonal cross section). Commenly however the expression “rod” is used for straithened tantalum wire also below 0.125 in. / 3.18 mm. X-medics offer tantalum rod products as small as 0.500 mm
Implantable Tantalum wire is defined as material up to 0.125″ (3.15 mm) in diameter

Basic Surgical Tantalum Material Grades (R05200 vs R05400)

The ASTM F560 , ISO 13782 and BS 7252-13 specify two acceptable base grades:

Type R05200: unalloyed tantalum vacuum-arc melted or electron-beam melted ingots.
Type R05400: powder-metallurgy consolidated unalloyed tantalum.

There are no difference in the mechanical requirements of tantalum type R05200 and R05400.  Concerning the chemical composition  of the tantalum slight higher oxygen and hydrogen levels accepted in R05400 surgical grade tantalum compred to R05200 as can be seen below.

Chemical Composition Requirement of Surgical Grade Tantalum

The requirements to the chemical composition of medical grade tantalum are considered fulfilled if the chemical analysis of the Ingot material fulfills the requirements. There are slightly differences in the acceptance criteria for R05200 and R05400 tantalum grades as can be seen below.

Element R05200 * R05400 **
max % (m/m) max % (m/m)
Carbon 0.010 0.010
Oxygen 0.015 0.03
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015
Niobium 0.10 0.10
Iron 0.010 0.010
Titanium 0.010 0.010
Tungsten 0.050 0.050
Molybdenum 0.020 0.020
Silicon 0.005 0.005
Nickel 0.010 0.010
Tantalum balance*** balance***

*) Electron-beam or vacuum-arc cast tantalum.
**) Sintered tantalum.
***) The percentage of tantalum is determined by difference and need not be determined or certified.

When supplying tantalum R05200 or R05400, the supplier shall provide a certification that the material was tested in accordance with the specification and met all requirements. A report of the test results shall be furnished to the purchaser at the time of shipment.

Chemical Composition additional Requirements

In addition to the requirements above the purchaser may request a report certifying the values of carbon, oxygen, nitrogen, and hydrogen as specified below for each lot of material supplied.

Element R05200 * R05400 **
max % (m/m) max % (m/m)
Carbon 0.020 0.020
Oxygen 0.025 0.035
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015

*) Electron-beam or vacuum-arc cast tantalum.
**) Sintered tantalum.

Mechanical properties of Surgical Grade Tantalum

The mechanical properties of the materials are to be evaluated as tensile strength and elongation. The specific parameter and test method depends on the form of tantalum metal (wire, strip, plate etc.) and can be found in the standards

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