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ASTM F2063-05
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
4 стр.
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84.24 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.040.30 Surgical. Including surgical dressings, sutures, etc. / Хирургические инструменты и материалы. Включая перевязочные, шовные и другие материалы
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Реферат

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.

Область применения

1.1 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.

1.2 Requirements are for mill product, measuring 6 to 130 mm (0.24 to 5.12 in.) diameter or thickness, in its annealed condition.

1.3 The values stated in SI units are to be regarded as the standard. The values given in inch-pound units are for information only.

Ключевые слова:
cardiac devices; metals; NiTi; TiNi; nitinol; nickel-titanium alloys; titanium-nickel alloys; orthopaedic medical devices; vascular devices; shape memory alloys; stents; superelastic alloys; surgical implants