影响体外鼠胚试验标准化的要素分析
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Analysis of factors affecting the standardization of in vitro mouse embryo test
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    摘要:

    不孕症已成为影响人类生殖健康的全球性问题,作为治疗不孕症的一种重要治疗手段,辅助生殖技术经过几十年的发展已经获得长足进步。辅助生殖技术用医疗器械产业快速发展,对此类产品进行风险管理,制定相应的安全性评价检测方法已势在必行。2016年行业标准YY/T 1434-2016《人类体外辅助生殖技术用医疗器械体外鼠胚试验》已经发布,本文就体外鼠胚试验中的关键节点和试验体系要素进行简要综述。

    Abstract:

    Infertility has become a global problem affecting human reproductive health. As an important treatment for infertility, assisted reproductive technology has made great progress over the past few decades. Rapid development has also taken place in medical devices for human assisted reproductive technology. It is imperative to establish the risk management and safety evaluation system of these products. In 2016, the industry standard YY/T 1434-2016 "Human in vitro Assisted Reproductive Technology With Medical Equipment in vitro Mouse Embryo Test" was officially released. In this paper, the key notes and elements of this in vitro mouse embryo test are briefly reviewed.

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史建峰,韩倩倩,王春仁.影响体外鼠胚试验标准化的要素分析[J].中国比较医学杂志,2017,27(7):102~106.

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  • 最后修改日期:2017-02-08
  • 在线发布日期: 2017-08-02
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