【国外标准】 Standard Specification for Silicone Elastomer Facial Implants

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.1.1 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.1.3 The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.