Standard Specification for Ureteral Stents
NORMA vydaná dňa 1.11.2022
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Designation standards: ASTM F1828-22
Publication date standards: 1.11.2022
The number of pages: 8
Approximate weight : 24 g (0.05 lbs)
Country: American technical standard
Kategória: Technické normy ASTM
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.This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short term use for drainage of urine from the kidney to the bladder. Ureteral stents shall be tested in accordance with the appropriate biological tests to meet the requirements prescribed. Retention strength, break strength, elongation, dynamic frictional force, and radiopacity shall be tested to meet the requirements prescribed.
Keywords:
indwelling devices, polymers, test methods, ureteral stents, urology,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)