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Since September the first 2009, joint replacements of hip and knee have been reclassified as part of the European Directive 2005/50/EC, amendment to the Directive 93/42/EEC concerning medical devices(MD). Following this new directive the MD are now classified in the class III and therefore require a systematic review of the design process. This design review goes through the stages of verification and validation steps in order to put into perspective the benefit/risk to the patient.

In this context, X.NOV set up a testing laboratory integrating mechanical and tribological testing machine MTS 858 Mini Bionix type II, for the validation of its implants.
This additional tool allows design validation:

• To study the influence of new materials, new forms, new manufacturing processes... on wear, kinematics and longevity of joint implants
• To provide documented evidence that proves the performance and compliance with the essential requirements concerning safety and health of patients, users and third parties