Um Quadro de Índice Multidimensional para Avaliar a Aplicabilidade Regulatória da ISO 10328 Usando um Caso de Estudo de Quadrilátero Protesico

Resumo

International biomechanical standards, such as ISO 10328 for lower-limb prosthetic testing, are widely used to guide device evaluation, yet their direct adoption into national regulatory systems often results in mismatches in safety expectations, documentation formats, and contextual use conditions. Despite extensive reliance on ISO standards, there is no structured method to assess whether these standards are appropriately aligned with regulatory requirements across different jurisdictions. Thi