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[关于申请状态的讨论和骨置换假肢注册的关键注意事项]

Jing Wu1, Jiazhen Zhang1, Ruhan A1

  • 1Center for Medical Device Evaluation, NMPA, Beijing, 100081.

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
|December 12, 2023
PubMed
概括

理想的骨置换假肢需要出色的生物相容性和声音传输. 本研究分析了骨置换假肢的材料特性和性能评估标准,以指导制造商和监管机构.

关键词:
声学特征 声学特征 声学特征医疗器械注册医疗器械的注册情况骨架重建 骨架重建 骨架重建骨性替代假肢 骨性替代假肢

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相关概念视频

The Auditory Ossicles01:11

The Auditory Ossicles

The auditory ossicles of the middle ear transmit sounds from the air as vibrations to the fluid-filled cochlea. The auditory ossicles consist of two malleus (hammer) bones, two incus (anvil) bones, and two stapes (stirrups), one on each side. These bones develop during the fetal stage and are the ones to ossify first. They are fully mature at birth and do not grow afterward.
The aptly named stapes look very much like a stirrup. The three ossicles are unique to mammals, and each plays a role in...
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