Rôle des normes dans les différents processus d'autorisation de mise sur le marché du matériel orthopédique

en The norms elaborated by national and international bodies contain essential information concerning various authorisation processes relevant to the marketing of orthopaedic equipment. Primarily, they guarantee the quality of the use and/or construction of equipment. Concerning authorisation specific to the marketing of hip prostheses (homologation), the AFNOR norms represent the globally validated criteria. Concerning authorisation of products marketed in Europe (EC marking), it is essential for safety purposes that the norms prescribed by the directives be strictly followed, and that equipment conforms to these norms. These norms, at the various stages in which they exist, result from a consensus between the different concerned parties. They have therefore been established a posteriori, and do not apply to innovative equipment. In these cases, the manufacturer must prove the product in a specific fashion. These norms results from open discussions, and the entire industry is in agreement to follow them. Finally, they are open to revision, and it is one of the fundamental roles of equipment vigilance to periodically challenge the accepted rules.