重磅！全国首个IVD试剂唯一标识编码下发！

admin · 发表于 2020-10-14 10:50:42

                  <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></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><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><p><br  /></p><section><span>来源：小桔灯网、浙江省标准化研究中心、赛柏蓝器械、体外诊断网</span></section><section><br  /></section></section></section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><span>近日，由迪安诊断、杭州云医购、浙江省标准化研究院共同发起制定的浙江省标准化协会团体标准 《体外诊断试剂唯一标识编码规范》（T/ZAS 2001—2020）正式发布。标志着作为医疗器械下最大分类之一的体外诊断，率先推出了细分领域的应用标准。</span></section><section><br  /></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/a3c99fd9f6b3ea3edfad960cb291bd1f_2.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><span>当前，国家全力试点推行医疗器械行业的唯一性标识UDI。作为开展第三方医学诊断工作的重要工具，体外诊断试剂能否采用国际统一的规则进行编码，关系着体外诊断试剂临床应用的质量管理，以及医疗供应链的运作效率与服务质量。</span></section><section><br  /></section></section><section data-support="96编辑器" data-style-id="22631"><section><section><p><span><strong>什么是体外诊断试剂唯一标识编码？</strong></span></p></section></section></section><section><br  /></section><section powered-by="gulangu"><section><span>体外诊断试剂唯一标识编码是IVD试剂的电子身份证。唯一标识数据载体是储存或者传输IVD试剂唯一标识的媒介，唯一标识数据库是储存IVD唯一标识的产品标识与关联信息的数据库。</span></section><section><br  /></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/0e07a45d93ee3354de0e01b060f31adb_3.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><span>体外诊断试剂编码对象包括IVD试剂在生产、包装、物流、应用等过程中的标识，以及产品信息、物流信息的有关内容。在上述各个环节通过IVD试剂编码进行管理，实现信息的上下游互联互通，并通过数据的手段可实现对IVD产品全生命周期进行“无死角”监督管理。</span></section></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><span><strong>体外诊断试剂唯一标识组成部分</strong><br  /></span></section><section><br  /></section></section><section powered-by="gulangu"><ul><li><section><span>体外诊断试剂产品标识代码（<em>device identification code for in-vitro diagnostic reagent</em>）。体外诊断试剂产品在生产流通全生命周期内稳定不变的、用于唯一标识其规格型号和包装的代码。<br  /></span></section><section><br  /></section><section><span><span>体外诊断试剂产品标识代码也可用作对体外诊断试剂唯一标识数据库存信息的“访问关键字”，关联体外诊断试剂产品信息、制造商信息、注册信息等</span>。</span></section><section><br  /></section></li><li><section><span>体外诊断试剂生产标识代码，（production identification codefor in-vitro diagnostic reagent）：识别体外诊断试剂生产过程中相关属性信息的代码<span>（注：根据实际应用需求，体外诊断试剂生产标识代码可包含体外诊断试剂的序列号、生产批号、生产日期、失效日期等</span>）</span></section></li></ul></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><span>体外诊断试剂唯一编码可以实现从产品到患者，患者到产品的双向追溯，对患者安全和产品安全有非常重要的意义。还可以通过IVD试剂唯一标识实现不良事件上报，操作简化，提高上报的准确率。</span></section><section><br  /></section><section><span>更重要的是，对医院来说可以让供应商的医疗器械信息在系统中一目了然，能够看到什么时候下订单，供应商什么时候发货，医院什么时候收货，什么时候结款等。</span></section><section><br  /></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/ab406a20de278ae8c6bd03ff17dd1258_4.png" /></p></section><section><br  /></section></section><section data-support="96编辑器" data-style-id="22631"><section><section><p><br  /></p><p><span><strong>规则与分类这样规定</strong></span></p></section></section></section><section><br  /></section><section powered-by="gulangu"><section><span>体外诊断试剂编码应当包括产品标识代码和生产标识代码，生产标识代码可与产品标识代码联合使用，指向特定的体外诊断试剂产品。</span></section><section><br  /></section></section><section powered-by="gulangu"><ul><li><section><span>产品标识代码是体外诊断试剂的唯一标识代码</span></section><section><br  /></section></li><li><section><span>生产标识代码是为识别体外诊断试剂不同属性而设置的代码</span></section><section><br  /></section></li><li><section><span>体外诊断试剂编码各部分应使用应用标识符表示其含义与格式</span></section></li></ul><section><br  /></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/7df930a583a668d44cf9433adb691fdc_5.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section><section><span><strong>产品编码应能满足：</strong></span></section><section><br  /></section></section><section powered-by="gulangu"><ul><li><section><span>识别体外诊断试剂生产企业、产品信息</span></section><section><br  /></section></li><li><section><span>有唯一性，对不同产品名称、商标、种类、规格、包装类型等基本特征不同的产品应分配不同的产品标识代码；同一产品标识代码不可在不同的体外诊断试剂上重复使用</span></section><section><br  /></section></li><li><section><span>具有足够的容量，满足对体外诊断试剂的监管和市场需求，在此前提下，编码的长度应尽可能短</span></section><section><br  /></section></li><li><section><span>具有稳定性，即在体外诊断试剂被赋予产品标识代码后，只要其基本特征没有发生变化，编码应保持不变，无论是长期连续生产还是间断式生产</span></section><section><br  /></section></li><li><section><span>应具有无含义性，产品标识代码中的每一位不表示任何与产品相关的特定信息</span></section></li></ul></section><section powered-by="gulangu"><section><br  /></section><section><span><strong>产品标识代码生产环节</strong><br  /></span></section><section><br  /></section><section><span>体外诊断试剂产品标识代码应由体外诊断试剂生产企业进行编码，并对其进行标识；</span></section><section><br  /></section><section><span>每个（批）体外诊断试剂分配一个唯一的体外诊断试剂产品标识代码，并关联生产日期、失效日期、序列号（批号）等生产信息。</span></section><section><br  /></section><section><span>生产标识代码根据体外诊断试剂管理的需要进行选取，包括对于体外诊断试剂生产过程相关的基本属性信息和体外诊断试剂流通过程相关的扩展属性信息，包括生产批号、序列号、生产日期、失效日期。</span></section><section><br  /></section><section><span>生产标识代码与产品标识代码联合使用，其中生产标识代码的基本属性采用表2的结构：</span></section><section><span></span><br  /></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/d73b111081c58615b772393f13cf6db6_6.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><span>扩展属性可采用表3的结构：扩展属性信息由流通中相关企业生成，使用时应与产品标识代码保持一致性。</span></section><section><span></span><br  /></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/d1dcb69ba5217185518ba04921551966_7.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><span><strong>产品标识代码包装环节</strong></span></section><section><br  /></section><section><span>将内装数量、货号、交货地位置码等包装信息与产品标识代码相关联，成包含包装信息的体外诊断试剂编码以及条码，粘贴到产品包装上，储运包装标签。</span></section><section><span><br  /></span></section></section><section powered-by="gulangu"><section><p><img src="image/20201014/c8f64d6419a74b88bc772d119f14344d_8.png" /></p></section></section><section powered-by="gulangu"><section><br  /></section><section><span>每个物流单元在物流过程中应根据体外诊断试剂产品标识代码分配一个唯一的物流单元标识，同时添加物流中相关信息，生成包含物流信息的体外诊断试剂编码以及条码的物流标签，加贴到物流包装上。</span></section><section><br  /></section><section><span>例如：某企业在为体外诊断试剂建立用于储运的非零售单元包装，内装产品标识代码为06901234567816，包装层级为1级，则该包装产品标识代码为16901234567813，生产日期为2018年2月1日，失效日期为2020年2月1日，批号为0001，货号为1001。</span></section></section><section powered-by="gulangu"><section><br  /></section><section><p><img src="image/20201014/d9005ecfe8015d703ff35fabba4811fa_9.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section><section><span><strong>IVD产品标识代码物流环节</strong><br  /></span></section><section><br  /></section></section><section powered-by="gulangu"><section><span>每个物流单元在物流过程中应根据体外诊断试剂产品标识代码分配一个唯一的物流单元标识，同时添加物流中相关信息，生成包含物流信息的体外诊断试剂编码以及条码的物流标签，加贴到物流包装上，物流标签。</span></section><section><br  /></section><section><span>例如：某体外诊断试剂物流企业将产品标识代码为06901234567892的体外诊断试剂1000件在2018年2月1日打包成一个物流单位：</span></section><section><br  /></section></section><section powered-by="gulangu"><ul><li><section><span>物流单元标识代码为069012340000000016</span></section><section><br  /></section></li><li><section><span>客户订单为1001</span></section><section><br  /></section></li><li><section><span>交货地位置码为6910001000012</span></section><section><br  /></section></li><li><section><span>装运标志代码为06901234000012349</span></section><section><br  /></section></li><li><section><span>采用GS1-128条码表示。</span></section></li></ul><p><br  /></p></section><section powered-by="gulangu"><section><p><img src="image/20201014/0d5ecd4263217063b18cfb02f95c06e7_10.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><span><strong>产品编码应能满足：</strong></span></section><section><br  /></section></section><section powered-by="gulangu"><ul><li><section><span>识别体外诊断试剂生产企业、产品信息</span></section><section><br  /></section></li><li><section><span>有唯一性，对不同产品名称、商标、种类、规格、包装类型等基本特征不同的产品应分配不同的产品标识代码；同一产品标识代码不可在不同的体外诊断试剂上重复使用</span></section><section><br  /></section></li><li><section><span>具有足够的容量，满足对体外诊断试剂的监管和市场需求，在此前提下，编码的长度应尽可能短</span></section><section><br  /></section></li><li><section><span>具有稳定性，即在体外诊断试剂被赋予产品标识代码后，只要其基本特征没有发生变化，编码应保持不变，无论是长期连续生产还是间断式生产</span></section><section><br  /></section></li><li><section><span>应具有无含义性，产品标识代码中的每一位不表示任何与产品相关的特定信息</span></section></li></ul><section><br  /></section></section><section><section><p><img src="image/20201014/efe9e817cdc3416caa65255cb26b8b1e_11.png" /></p></section></section><section powered-by="gulangu"><section><span>（IVD产品标识代码）</span></section></section><section><br  /></section><section data-support="96编辑器" data-style-id="22631"><section><section><p><span><strong>IVD试剂唯一标识或迎全国普遍实施</strong></span></p></section></section></section><section><br  /></section><section><span>7月</span><span>28日，据国家药监局官网消息，该局日前召开了医疗器械唯一标识系统试</span><span>点工作推进会，就下一步推动试点工作进行部署。</span></section><section><span><br  /></span></section><section powered-by="gulangu"><section><p><img src="image/20201014/57c9f5008406e04bee11dd96cee4d0c0_12.png" /></p></section><section><br  /></section></section><section powered-by="gulangu"><section><span>国家药监局指出，医疗器械唯一标识是医疗器械的“身份证”，是唯一、精准识别医疗器械的基础，贯穿医疗器械生产、流通、使用各环节，有助于医疗器械全生命周期管理。</span></section><section><br  /></section><section><span>而此次《体外诊断试剂唯一标识编码规范》（T/ZAS 2001—2020）正式发布。标志着作为医疗器械下最大分类之一的体外诊断，率先推出了细分领域的应用标准。</span></section><section><br  /></section><section><span>未来对医院来说，有了IVD试剂统一标识，依托其信息化的管理系统，更加便于对体外诊断试剂进行管理，通过IVD试剂唯一标识系统，医疗机构或第三方等单位利用专业工具扫码即可了解IVD生产、流通、经营等全生命周期信息。</span></section><section><br  /></section></section><section powered-by="gulangu"><section><span>若此次浙江省标协出台的团体标准—IVD试剂唯一标识系统的成功在浙江省医疗机构试点，即验证了IVD全链条各环节实施唯一标识的可能性，未来或将向全国推广。</span></section></section><section><br  /></section><section><section data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section 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