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<section powered-by="gulangu"><section><section><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section>关注</section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><br /></section></section><section><section><section><span data-positionback="static"><p><img src="image/20201014/4e10c908b7214c0bc41a23af0b888bf2_2.png" /></p></span></section></section></section><p><strong><span>来源：中国医药报</span></strong></p><p><strong><span><br /></span></strong></p><p>3月20日，国家药品监督管理局发布通知，公布今年拟制修订93个医疗器械行业标准，分别为新制定标准59项，修订标准34项。其中5项为强制性标准。</p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/bae40861352751e990300cb56ec6d6d0_3.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong><span>属于新制定的行业标准项目有</span></strong>“医用电气设备 医用轻离子束设备 性能特性”“乙型肝炎病毒e抗体检测试剂盒（化学发光免疫分析法）”“荧光免疫层析分析仪” “耳聋基因突变检测试剂盒” “医用电气设备能耗测量方法” “人类辅助生殖技术用医疗器械 人工授精导管”等，其中“乙型肝炎病毒e抗体检测试剂盒（化学发光免疫分析法）”为强制性标准。</p><p><br /></p><p><strong><span>属于修订的行业标准项目包括</span></strong>“免疫组织化学试剂”“皮内针”“医用电气设备 第2-31部分：带内部电源的体外心脏起搏器的基本安全和基本性能专用要求”“医用电气设备 第2-50部分：婴儿光治疗设备基本安全和基本性能的专用要求”“一次性使用人体静脉血样采集容器”“专用输液器 第5部分：一次性使用吊瓶式和袋式输液器”等，其中，“医用电气设备 第2-31部分：带内部电源的体外心脏起搏器的基本安全和基本性能专用要求”“医用电气设备 第2-50部分：婴儿光治疗设备基本安全和基本性能的专用要求”“一次性使用人体静脉血样采集容器”“专用输液器 第5部分：一次性使用吊瓶式和袋式输液器”均为强制性标准。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>标准制修订任务将分别由北京、天津、辽宁、上海、浙江、山东、湖北、广东省（市）药品监督管理局下属医疗器械检验检测单位，中检院（国家药监局医疗器械标准管理中心），北京大学口腔医学院口腔医疗器械检验中心，北京国医械华光认证有限公司等单位承担。<br /></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p>通知特别指出，承担标准制修订任务的医疗器械标准化技术委员会及技术归口单位要做好标准的组织起草、验证、征求意见和技术审查等工作，广泛听取意见，加强与有关方面的沟通协调，确保标准技术内容的科学性、合理性、适用性以及与相关政策要求的符合性。</p><p><br /></p><p>2018年12月11日，国家药品监督管理局公布了2019年拟制修订的94项医疗器械行业标准制修订计划项目。根据计划，2019年拟制定60项、修订34项医疗器械行业标准，其中强制性标准有6项。原江苏省医疗器械检测所承担的“医用电气设备第2-66部分：听力设备及听力设备系统基本安全和基本性能专用要求”因已在国家标准委员会立项，故在此次发布中取消。</p><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>2019年医疗器械行业标准制修订项目</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p>（点击可查看大图）</p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/1009e2caaf42aeb2120f0f1b5693adfb_4.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/3c4c0886bc5b7a65ce58db40a93e6bd0_5.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/041bcc049fd99743682dab5415258b49_6.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/9c0fb9a6f42c79d3b3c21310b26379b3_7.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/0b0efebbb40ae96f0be1768acc79ec30_8.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/64acbc483f0ff2121ee81107a328efc7_9.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/97622bd90812455afd8913573068bbb8_10.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/d22b4f0840641b7269ebc7a16c46a068_11.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/8fb58b36357cc4905d3b2cb56fe54097_12.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/b43ad99024c3ab158041e960bfb81837_13.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/aa4717eea0e3a45018ef8c7825c600e0_14.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/fc64b8664e311e49ece3d43cd83ef9dc_15.jpg" /></p></section></section><p><br /></p><p><br /></p></section><p><br /></p><p><strong><span>本文由整理自外网，转载请注明出处。</span></strong></p><p><strong><span><br /></span></strong></p><p><br /></p><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><p><span><strong>相关阅读</strong></span></p></section><p><p><img src="image/20201014/ec237188ae1e9c03eb4d9814f31b18ab_16.gif" /></p></p><p><br /></p><p><span>医疗器械行业“招标采购” 四大重点领域将有新发展</span><br /></p><p><br /></p><p><span>累计54个！国家药监局已批准上市的创新医疗器械！</span><br /></p><p><br /></p><p><span>案例！医疗器械成专利侵权纠纷重灾区！</span><br /></p><p><br /></p><p><span>如何控制医疗器械市场进入成熟期后产生的价格压力？</span><br /></p></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p><span><strong><span>点击阅读原文即可访问官方网站！</span></strong></span></p>
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发表于 2020-10-14 14:31:17