Многоуровневая рамка индекса для оценки регуляторной применимости ISO 10328 с использованием кейса с протезом коленного сустава

Аннотация

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