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陕西省医疗器械质量监督检验院 >> 信息动态 >> 标准信息 >> 正文
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陕西省医疗器械质量监督检验院 >>标准信息 >> 正文
国家药品监督管理局关于批准发布YY/T 0127.13—2018《口腔医疗器械生物学评价 第13部分:口腔黏膜刺激试验》等8项医疗器械行业标准和2项修改单的公告(2018年第4号)
作者: 信息来源:转载自国家局网站 点击数:1081 更新时间:2018/4/18 4:01:41

  YY/T 0127.13—2018《口腔医疗器械生物学评价 第13部分:口腔黏膜刺激试验》等8项医疗器械行业标准和YY 0581.2—2011《输液连接件 第2部分:无针连接件》第1号修改单、YY 0598—2015《血液透析及相关治疗用浓缩物》第1号修改单已经审定通过,现予以公布。标准自2019年5月1日起实施,修改单自发布之日起实施。标准编号、名称如下:

YY/T 0127.132018

口腔医疗器械生物学评价13部分:口腔黏膜刺激试验

YY/T 0127.152018

口腔医疗器械生物学评价15部分:亚急性和亚慢性全身毒性试验:经口途径

YY/T 04972018

一次性使用无菌胰岛素注射器

YY/T 05212018

牙科学种植体骨内牙种植体动态疲劳试验

YY/T 05872018

一次性使用无菌牙科注射针

YY/T 15892018

雌二醇测定试剂盒(化学发光免疫分析法)

YY/T 15942018

人抗甲状腺球蛋白抗体测定试剂盒

YY/T 15982018

组织工程医疗器械产品用于脊柱融合的外科植入物的骨修复或再生评价试验指南

  标准适用范围及修改单内容见附件。

  特此公告。

  附件:1. YY/T 0127.13—2018《口腔医疗器械生物学评价第13部分:口腔黏膜刺激试验》等8项医疗器械行业标准适用范围
     2. YY 0581.2—2011《输液连接件 第2部分:无针连接件》第1号修改单
     3. YY 0598—2015《血液透析及相关治疗用浓缩物》第1号修改单


国家药品监督管理局
2018年4月11日

国家药品监督管理局2018年第4号公告附件1.doc

国家药品监督管理局2018年第4号公告附件2.doc

国家药品监督管理局2018年第4号公告附件3.doc

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