Abstract

Essence of properties and characteristics rendering a non-active surgical implant optimum or ideal has hitherto been lacking and requires further consideration. Definitions governing medical devices given in leading geo-political regulatory domains are insufficient to specify fundamental attributes of non-active surgical implants. Equally, voluntary, non-majoritarian goal-oriented standards on non-active surgical implants are devoid of fundamental attributes of such product. Exploration of fundamentals of non-active surgical implants, their properties and characteristics permits formulation of implant rules based on the concept of implant potential, also proposed herein. Implant rules deduced from implant potential promote uniform, scientific assessment and comparison, offering numerous obvious benefits. In this article, we explore fundamentals of non-active surgical implant, their properties and characteristics and propose implant rules based on implant potential, from which concepts of optimum physiological function and implant potential, respectively, are proponed. They might even improve standards on or relevant to non-active surgical implant published by standard organisations.

Keywords: Implants; Surgical; Non-active; Optimum; Ideal; Rules; Regulation