标准摘要
[中文适用范围]: 本国际标准规定了用于骨缝合术的非主动外科植入物(以下简称植入物)的特殊要求。 除了 ISO 14630 之外,该国际标准还对预期性能、设计属性、材料、设计评估、制造、灭菌、包装和制造商提供的信息提出了特殊要求。 [外文原描述]: ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
英文名称Non-active surgical implants — Implants for osteosynthesis — Particular requirements