ART Italian National Register, National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, 00161 Rome, Italy.
Placenta. 2011 Sep;32 Suppl 3:S243-7. doi: 10.1016/j.placenta.2011.07.003. Epub 2011 Jul 23.
The application of the European Tissues and Cells Directive requires that a high standard of quality and safety be applied to all tissue establishments, including that of assisted reproductive centres. In the countries where the Directive has been implemented, changes in the ART clinic and laboratory procedures have been made. However, many requirements stipulated in the Directive are already in place in some European countries and are mandatory by the country specific laws, while some other requirements have been recently implemented. In this article the benefits and the potential risks of the Directive implementation on the efficacy, safety and cost of all the different assisted reproductive technologies performed, including cryopreservation techniques and storage policies have been widely analysed. The feasibility of the implementation of some of the specific requirements when considering the delicate issues of reproductive cells in contrast to other cells or tissues covered by the Directive has been evaluated.
《欧洲组织和细胞指令》的应用要求所有组织机构，包括辅助生殖中心，都要达到高标准的质量和安全水平。在已经实施该指令的国家，ART 诊所和实验室程序发生了变化。然而，该指令中规定的许多要求在一些欧洲国家已经存在，并且受到国家特定法律的强制要求，而其他一些要求则是最近才实施的。本文广泛分析了《指令》的实施对所有不同辅助生殖技术（包括冷冻保存技术和存储政策）的疗效、安全性和成本的好处和潜在风险。在考虑到生殖细胞与指令涵盖的其他细胞或组织的微妙问题时，评估了实施一些特定要求的可行性。
