ISO/NP 24685

Implants for surgery — Cranioplasty plates — Specific requirements for non-moldable plates

Scope

​​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.​