This specification covers the requirements for silicone elastomer implants used in facial surgery, that is, chin, nasal, malar, and ear implants. The primary material of construction shall be fully vulcanized silicone elastomer. Implants may have orientation means or sites of attached fixation materials, or both. Different tests shall be conducted in order to determine the following properties of elastomers: elongation at failure, tensile strength, modulus, and tear.
Область применения1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
1.2 Limitations This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom-fabricated prosthesis manufactured to any other specification.