European Regulations and Their Impact on Tissue Banking
European Regulations and Their Impact on Tissue Banking
复制标题
欧洲法规及其对组织库的影响
DOI：
10.1007/s10561-006-9008-x
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发表时间：
2006
影响因子：
1.5
通讯作者：
A. Tatarenko
中科院分区：
文献类型：
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作者：
A. Tatarenko
欧洲委员会与欧盟的广泛合作确保了可被视为最佳做法建议的欧洲委员会指南原则与规定了具有法律约束力要求的欧盟指令技术要求之间的一致性和互补性。这意味着整个欧洲大陆现在都有同样的标准。拥有一套共同的标准有利于不同医疗保健系统之间的合作，特别是在紧急情况下，以及进出口问题。采用相同的质量管理和可追溯性系统有助于将风险降至最低并防止疾病传播。它使在国外接受治疗的患者放心。组织机构需要引入技术和结构变化，以遵守新的规定，最终挽救和改善许多患者的生命。
Extensive CoE-EU cooperation ensures coherence and complementarities between the principles of the CoE guides which can be regarded as recommendations on best practice, and the technical requirements of the EU directives which set out legally binding requirements. This means that the same standards now exist throughout European continent. Having a common set of standards facilitates cooperation between different healthcare systems, especially in cases of emergencies, and the export–import issues. Adoption of the same quality management and traceability systems helps to minimise the risks and prevent disease transmissions. It reassures patients who undergo treatments outside of their countries. The tissue establishments need to introduce technical and structural changes to adhere to the new regulations which ultimately results in saving and improving of lives of many patients.