Standards Development
This International Standard will specify general requirements for the development and evaluation of implantable cranioplasty plates. With regard to safety, this International Standard will give requirements for design attributes, materials, manufacture, sterilization, packaging, information supplied by the manufacturer and tests to demonstrate compliance with these requirements. Additional tests will be given or referred to in level 1 and level 2 standards.
The patient-specific implant is a regulatory challenge, because each patient will have an unique plate manufactured only for himself. There is no international standard that addresses the requirements for a given patient-specific implant, and we pretend to do so on this standard, which will provide great insight for regulation of this kind of product
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