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ASTM F2633-19
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
Name übersetzen
NORM herausgegeben am 1.11.2019
Informationen über die Norm:
Bezeichnung normen: ASTM F2633-19
Ausgabedatum normen: 1.11.2019
SKU: NS-980112
Zahl der Seiten: 5
Gewicht ca.: 15 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Kategorie - ähnliche Normen:
Die Annotation des Normtextes ASTM F2633-19 :
This specification covers the chemical, mechanical, and dimensional requirements for wrought seamless nickel-titanium shape memory alloy tubes used for the manufacture of medical devices and surgical implants. Tubes shall be furnished in the superelastic condition, and the outer surface shall have a pickled, ground, or mechanically polished finish, or as agreed upon between purchaser and supplier. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms. This specification applies precisely to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. The mechanical properties to which the tubes shall conform are ultimate tensile strength (UTS), uniform elongation, upper plateau strength, lower plateau strength, and residual elongation.
Keywords:
medical devices, metals (for surgical implant), nickel-titanium alloys, niti, nitinol, shape memory alloy, stents, superelastic alloys, surgical implants, tube,, ICS Number Code 77.150.40 (Nickel and chromium products)
Ergänzende Informationen
| 1. Scope | ||||||||||||||||
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1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063. 1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. 1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for information only. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
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