1.1 本规范涵盖了面部手术中使用的硅橡胶植入物（即下巴、鼻腔、颧骨和耳朵植入物）的要求。 1.2 限制- 本规范不包括含有硅胶或其他凝胶或液体的植入物。它不一定涵盖根据任何其他规范制造的任何定制假体。 1.3 以下安全隐患警告仅适用于机械测试和测试方法部分，第节 7. 本规范中的: 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

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.