ASTM F1828-22

ASTM F1828-22

novembre 2022
Norme En vigueur

Standard Specification for Ureteral Stents

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.

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Informations générales

Collections

Normes américaines ASTM

Date de publication

novembre 2022

Nombre de pages

8 p.

Référence

ASTM F1828-22

Indice de classement

F1828-22
Résumé
Standard Specification for Ureteral Stents

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.

Normes remplacées (1)
ASTM F1828-17
mars 2017
Norme Annulée
Standard Specification for Ureteral Stents

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.

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