规定了用于骨合成的非活性外科植入物的特殊要求。它还对预期性能、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。结合AS ISO 14630:2015阅读。
Specifies particular requirements for non-active surgical implants for osteosynthesis. It also gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. To be read in conjunction with AS ISO 14630:2015.