Tantalum for Surgical Implants
 The demand to surgical grade tantalum (i.e. tantalum used in medical devices) are specified in a number of standards like:
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 orthopaedic surgery or in the manufacture of surgical implants. The material specification in the standards are substantially similar.
A number of forms are covered by the standards. ASTM F560 differentiates the product in the following way:
- Tantalum plate for surgery are defined a flat product more than 0.1875 in. (4.7 mm) in thickness.
- Surgical 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)
- Implantable Tantalum wire defined as material up to 0.125" (3.15 mm) in diameter
The ASTM F560 , ISO 13782 and BS 7252-13 specify two acceptable tantalum types:
- Type R05200: unalloyed tantalum vacuum-arc melted or electron-beam melted ingots.
- Type R05400: powder-metallurgy consolidated unalloyed tantalum.
The requirements to the chemical composition are considered fulfilled if the chemical analysis of the Ingot material fulfills the requirements. There are slightly differences in the acceptance criteria for the two types of tantalum metals as can be seen below:
| Element |
R05200 *
max % (m/m) |
R05400 **
max % (m/m) |
Carbon
Oxygen
Nitrogen
Hydrogen
Niobium
Iron
Titanium
Tungsten
Molybdenum
Silicon
Nickel
Tantalum |
0.010
0.015
0.010
0.0015
0.10
0.010
0.010
0.050
0.020
0.005
0.010
balance*** |
0.010
0.03
0.010
0.0015
0.10
0.010
0.010
0.050
0.020
0.005
0.010
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.
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.
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 *
max % (m/m) |
R05400 **
max % (m/m) |
Carbon
Oxygen
Nitrogen
Hydrogen |
0.020
0.025
0.010
0.0015 |
0.020
0.035
0.010
0.0015 |
*) Electron-beam or vacuum-arc cast tantalum.
**) Sintered 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 fund in the standards. | 
