Vaquier C, Legrand D, Caldani C
Centre Hospitalier Universitaire de Nice, 06003 Nice cedex 1, France.
Transfus Clin Biol. 2009 May;16(2):245-52. doi: 10.1016/j.tracli.2009.03.005. Epub 2009 May 14.
Since 1985, a Council Resolution defines a new approach to technical harmonization and standards. The directives resulting from this new approach establish the essential safety requirements with which products put on the market must conform, and which should therefore enjoy free movement throughout the European Union, owing to a presumption of conformity. However, if the manufacturer is responsible for the conformity of its product in terms of safety, it is the end-user who must make sure that its requirements for a specific use or a considered application are satisfied and that the product meets its needs. It is the objective of the procedure of validation, which calls upon protocols of qualification intended to show the aptitude of a material, a system, a device, of an installation, to meet the requirements of specified quality and safety. This concept of qualification applies to the data-processing software of the hospital blood banks. Only the stage of operational qualification will be developed here. It involves scenarios made up of test files which make it possible to check the electronic data interchanges between the hospital blood bank and the blood establishment (transmission of the results of analysis, transmission of the data of traceability), as well as the functions of assistance to the issuing of the labile blood products.
自1985年以来，一项理事会决议确定了技术协调与标准的新方法。这种新方法产生的指令规定了投放市场的产品必须符合的基本安全要求，因此，由于符合推定，这些产品应能在整个欧盟自由流通。然而，如果制造商负责其产品在安全方面的合规性，那么最终用户必须确保其对特定用途或特定应用的要求得到满足，并且产品符合其需求。这就是验证程序的目标，该程序要求进行鉴定方案，以证明材料、系统、设备、装置符合规定的质量和安全要求。这种鉴定概念适用于医院血库的数据处理软件。这里仅阐述运行鉴定阶段。它涉及由测试文件组成的场景，这些场景可以检查医院血库与血站之间的电子数据交换（分析结果的传输、可追溯性数据的传输），以及协助发放易腐血液制品的功能。
