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Chinese Standard: GB/T 12417.1-2008

Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 1:Particular requirements for osteosynthesis implants

IDT  ISO 14602:1998

全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

GB/T 12417的本部分规定了骨接合用无源外科植入物(以下简称植入物)的特殊要求。
除ISO 14630规定的条款要求外,本部分对植入物的预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息又做出了特殊要求。

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