4. 의료용 합금소재(ASTM F2036,F1472,F67,F136,F1713,F1813)

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ASTM F2063 ,Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices

and Surgical Implants. This specification covers the chemical, physical, mechanical,

and metallurgical requirements for wrought nickel-titanium bar, flat rolled products,

and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture

of medical devices and surgical implants. The material shall be made from ingot

made from nickel and titanium with no other intentional alloy additions. The material

shall be vacuum or inert atmosphere melted to control metallurgical cleanliness

and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or

cold finished and annealed or heat treated. Surface condition may be oxidized,

descaled, pickled, blasted, machined, ground, mechanically polished, or

electropolished. Major elements shall be analyzed by direct current plasma

spectrometry, atomic absorption, inductively coupled plasma spectrometry,

X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method.

Carbon shall be measured by combustion and hydrogen shall be measured by inert

gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured

by inert gas fusion. The nickel and titanium contents of nickel-titanium shape

memory alloys cannot be measured to a precision required to guarantee shape

memory or superelastic properties. Calorimetry or an equivalent thermomechanical

test method must be used to assure the alloy formulation in terms of transformation

temperature. Mechanical properties of the samples such as tensile strength

and elongation shall be determined after annealing.

ASTM F1472 Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant

Applications (UNS R56400). This specification covers the requirements for wrought

titanium-6aluminum-4vanadium alloy for use in surgical implant applications.

The material shall be manufactured by multiple melting in plasma arc and electron

beam furnaces into strip, sheet, plate, bar, forging bar, or wire. The material shall be

available in the annealed or cold-worked condition, with the surface mechanically

descaled or pickled, sandblasted, chemically milled, ground, machined, peeled,

polished, or a combination of these. Heat and product analyses as well as tension

and bend (for sheet, strip, and plate) tests shall be performed and shall conform

to the requirements specified. In addition, the material shall have a microstructure

consisting of a fine dispersion of alpha and beta phases as a result of processing

in the alpha plus beta field, with no continuous alpha network at prior beta grain

boundaries and no coarse, elongated alpha platelets.

ASTM F136 Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial)

Alloy for Surgical Implant Applications (UNS R56401).This specification covers

the chemical, mechanical, and metallurgical requirements for wrought annealed

titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be

used in the manufacture of surgical implants. The products are classified into:

strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform

to the chemical composition requirements specified. Product analysis tolerances

do not broaden the specified heat analysis requirements but cover variations

between laboratories in the measurement of chemical content. Tension test

and bend test shall be performed to meet the requirements specified.

ASTM F1713  Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implan

Applications (UNS R58130). This specification covers the chemical, mechanical,

and metallurgical requirements for wrought titanium-13niobium-13zirconium

alloy (UNS R58130) bars and wires to be used in the manufacture of surgical

implants. The mill products may be supplied as specified by the purchaser

with a descaled or pickled, abrasive blasted, chemically milled, ground, machined,

peeled, or polished finish. Materials shall be furnished in the unannealed,

solution-treated, or capability-aged condition. The mechanical properties

to which the alloys shall conform are tensile strength, yield strength, elongation,

and reduction of area.

ASTM F1813  Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy

for Surgical Implant (UNS R58120). This specification covers the chemical,

mechanical, and metallurgical requirements for wrought titanium-12

molybdenum- 6 zirconium-2 iron alloy for surgical implants to be used

in the manufacture of surgical implants. The heat analysis shall conform

to the chemical composition requirements prescribed. Ingot analysis may be

used for reporting all chemical requirements, except hydrogen. The wrought

titanium-12 molybdenum-6 zirconium-2 iron alloy are classified as bar,

forging bar and wire. The ultimate tensile strength, yield strength, elongation,

and area reduction of the material shall be tested to meet the requirements prescribed.