Projet de travail approuvé
ϲʿ/AWI 16428
Implants chirurgicaux — Solutions d'essai et conditions environnementales pour les essais statiques et dynamiques de corrosion sur les matériaux et dispositifs médicaux implantables
Numéro de référence
ϲʿ/AWI 16428
Edition 2
Projet de travail approuvé
ϲʿ/AWI 16428
90356
Un groupe de travail a préparé un projet.
Remplacera ϲʿ 16428:2005

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ϲʿ 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.

Typical articulating joint simulator tests and aspects particular to the dental field are not considered by ϲʿ 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ϲʿ 16428:2005.

Informations générales

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  • ϲʿ/TC 150/SC 1
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