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陕西省医疗器械质量监督检验院 >> 信息动态 >> 最新动态 >> 正文
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陕西省医疗器械质量监督检验院 >>最新动态 >> 正文
省器械检验院参加2019年全国医疗器械 检验机构比对试验结果分析研讨会
作者:未知 信息来源:本站原创 点击数:119 更新时间:2019/11/22 11:08:58

1118日~11月20日,2019年医疗器械检验机构比对试验结果分析研讨会在成都召开,省器械检验院作为除全国十大中心外的省级检验机构首次协办无源类比对试验项目,参加了此次会议并进行了结果汇报。

201810月,省器械检验院领受《金属洛氏硬度-C标尺》比对试验任务并开始组织筹备工作。一是成立领导小组。由一名副院长任组长,物理材料室3名同志任组员的检验领导小组,主要负责样品研制、发放、比对试验的实施等;二是开展调研走访。先后到省内外多家样品制备厂家调研走访,在考察了多家样品制备厂商后,筛选具备最严格、最优化的工艺、标准物质生产资质的厂家,委托生产本次比对试验样品;三是扎实评价验证。在厂家交付金属洛氏硬度比对样品后,工作小组迅速开展了样品的均匀性和稳定性评价;四是快递准确发样。为保证样品发放环节的准确无误,工作人员严格按照试验室代码进行样品发放,做到快递包装严实,确保样品免受碰撞划伤、样品与包装标识信息准确一致;五是精准统计分析。对各参加试验室报送试验结果与资料进行统计、技术分析,确保数据无误。

会上省器械检验院22家实验室报送的金属洛氏硬度-C标尺比对结果资料作了详细分析汇报,9名与会专家对技术分析结果一致认可通过。中检院对该院所做扎实有效的工作给予了充分肯定,称这次比对试验“组织有力、程序严谨、数据准确、结果可靠”。

这次协办比对试验工作,对于该院承办比对试验既积累了经验,又提高了检验能力,为提升省器械检验院在行业内的影响力和知名度起到了促进作用。

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