XP E67-305

Additive manufacturing - Specificities for medical device manufacturing

La fabrication additive regroupe les technologies permettant de fabriquer des pièces par couches successives de matière à partir d'un modèle numérique. Par rapport aux méthodes classiques de fabrication pour lesquelles les pièces sont moulées à un format spécifique soit obtenues par usinage ou découpage d'un bloc de matière, elles permettent de construire des pièces aux formes complexes. Le présent document fixe les particularités à respecter sur toute la chaîne de fabrication additive des dispositifs médicaux, depuis la matière première jusqu'à la pièce finie.

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