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.
Registration number (WIID)
87692
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.
