This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.

1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.