标准摘要
[中文适用范围]： 本文件规定了乳房植入物的具体要求。就安全而言，本文件针对预期性能、设计属性、材料、设计评估、制造、包装、灭菌和制造商提供的信息提出了要求。 [外文原描述]： This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.
英文名称Non-active surgical implants — Mammary implants — Specific requirements