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引用次数: 2

摘要

在输血过程中,设备的鉴定是一个特别重要的阶段。一方面,许多标准,如认证或认可的标准都要求它,就像良好的输血规范一样;此外,质量保证步骤的实践也发展了这方面。事实上,没有实现对成品有影响的材料的这种定性,可能导致产品出现错误。这一资格要经过几个阶段,其中一些是主要的,如起草条件的时间表,起草资格的操作规程,为日常设置作出决定。最后,为了使这一资格得到充分的体现,有必要采取与国际计量制度相联系的方法。此外,某些问题在反思后必须找到答案,如检查哪个单元,只有这一个,设备是-它是一个复杂的,有维修合同吗?一旦考虑到所有这些因素,问题找到了答案,那么就可以很好地建立业务议定书,就可以决定日常的设置,并确定最后阶段。
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[Equipment qualification].
The qualification of the equipment is a particularly important stage in the transfusional process. On the one hand, of many standards such as those of certification or that of accreditation require it, just as the good transfusional practices; in addition, the practices of steps of quality assurance develop this aspect. Indeed, the absence of the realization of this qualification of material having an influence on the finished product, can lead to an error in the product. This qualification passes by various stages of which some are major such as the drafting of the schedule of conditions, the drafting of the operational protocol of qualification, the decision made for the setting in routine. Finally so that this qualification takes all its dimensions it is necessary to carry out methods linked to the international system of measurement. Moreover certain questions after reflexions must find response such as which unit to check, and only this one, the equipment is - it a complex one, is there a maintenance contract? Once all these elements taken into account, the questions having found their answer, the operational protocol will then well be built, the decisions of settings in routine could be done and the sets of the finalized stages.
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