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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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总局关于批准发布YY 0285.5—2018《血管内导管 一次性使用无菌导管 第5部分:套针外周导管》等16项医疗器械行业标准的公告(2018年第27号)
作者: 信息来源:转载自国家总局网站 点击数:885 更新时间:2018/3/2 9:32:51

  YY 0285.5—2018《血管内导管 一次性使用无菌导管 第5部分:套针外周导管》等16项医疗器械行业标准已经审定通过,现予以公布。标准自2019年3月1日起实施,标准编号、名称如下:

YY 0285.52018

血管内导管一次性使用无菌导管5部分:套针外周导管

YY/T 05282018

牙科学金属材料腐蚀试验方法

YY/T 15782018

糖化白蛋白测定试剂盒(酶法)

YY/T 15792018

体外诊断医疗器械体外诊断试剂稳定性评价

YY/T 15802018

肌酸激酶MB同工酶测定试剂盒(免疫抑制法)

YY/T 15812018

过敏原特异性IgE抗体检测试剂盒

YY/T 15822018

胶体金免疫层析分析仪

YY/T 15832018

叶酸测定试剂盒(化学发光免疫分析法)

YY/T 15842018

视黄醇结合蛋白测定试剂盒(免疫比浊法)

YY/T 15862018

肿瘤个体化治疗相关基因突变检测试剂盒(荧光PCR法)

YY/T 15882018

降钙素原测定试剂盒

YY/T 15902018

心型脂肪酸结合蛋白测定试剂盒(免疫比浊法)

YY/T 15922018

ABO正定型和RhD血型定型检测卡(柱凝集法)

YY/T 15932018

生长激素测定试剂盒

YY/T 15992018

牙科学聚合物基修复材料聚合收缩测试方法激光测距法

YY/T 16052018

糖化血红蛋白测定试剂盒(胶乳免疫比浊法)

  上述标准适用范围见附件。

  特此公告。

  附件:YY 0285.5—2018《血管内导管 一次性使用无菌导管第5部分:套针外周导管》等16项医疗器械行业标准适用范围


食品药品监管总局
2018年2月24日

2018年第27号公告附件.doc

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