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使用欧洲规范对组织和细胞制剂进行编码。

Coding of Tissue and Cell Preparations Using Eurocode.

作者信息

Knels Ralf, Stüpmann Kirstin, Pruß Axel, Klerke Jan, Kardoeus Joachim, Hiller Jens

机构信息

Eurocode International Blood Labeling System e.V., Dresden, Germany.

German Red Cross Blood Donation Service Mecklenburg-Vorpommern, Rostock, Germany.

出版信息

Transfus Med Hemother. 2017 Nov;44(6):401-405. doi: 10.1159/000484416. Epub 2017 Nov 17.

Abstract

Traceability of products requires their unique identification. In Germany blood products have been encoded by Eurocode since 1998. EU Directives 2004/23/EC, 2006/86/EC and 2015/565/EC demanded unique identification and safe traceability procedure also for tissues and cells. Eurocode IBLS e.V. and the German Society of Transfusion Medicine and Immunohematology (DGTI) working parties '!' within the Single European Code (SEC). Several data elements of Eurocode can be used to create the complete SEC data structure, except the tissue establishment number. This can be found on the EU Coding Platform in the internet. Consequently, existing software and labeling solutions in Eurocode format could be easily upgraded with SEC.

摘要

产品的可追溯性要求对其进行唯一标识。自1998年以来,德国的血液制品已采用欧洲编码进行编码。欧盟指令2004/23/EC、2006/86/EC和2015/565/EC也要求对组织和细胞进行唯一标识和安全的追溯程序。欧洲编码IBLS电子协会和德国输血医学与免疫血液学协会(DGTI)在单一欧洲编码(SEC)内开展工作。除了组织机构编号外,欧洲编码的几个数据元素可用于创建完整的SEC数据结构。这可以在互联网上的欧盟编码平台上找到。因此,现有的欧洲编码格式的软件和标签解决方案可以很容易地升级为SEC格式。

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