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中国辅助生殖技术(ART)在近30年里发展迅速,已接近国际先进水平。但是,我国ART标准化的工作尚处于初级阶段。加拿大标准协会(CSA)自2000年开始进行“辅助生殖组织”国家标准的制订。本文分3个单元介绍加拿大“辅助生殖组织”(CAN/CSA-Z900.2.1-12)国家标准的主要内容。该标准涵盖了辅助生殖组织管理的各个方面,包括公司与工作人员的要求,设备的要求,标准的操作程序、规范及质量控制,记录和随访的要求,感染的预防及控制,捐赠者和接受者的规范,不良事件的监控等。该标准的有关内容值得研究和借鉴,可为我国ART和相关医疗器械产品的科学监管,以及辅助生殖中心的规范管理提供参考,从而促进该领域的健康有序发展。
China assisted reproductive technology (ART) in the rapid development of nearly 30 years, is close to the international advanced level. However, the standardization of ART in our country is still in its infancy. Canadian Standards Association (CSA) since 2000 to carry out “assisted reproductive tissue ” national standards. This paper introduces the main contents of the national standards of Canada “assisted reproductive tissues ” (CAN / CSA-Z900.2.1-12) in 3 units. The standard covers aspects of assisted reproductive tissue management including company and staff requirements, equipment requirements, standard operating procedures, regulatory and quality control, documentation and follow-up requirements, prevention and control of infections, donors and acceptance Norms, adverse events such as monitoring. The relevant content of this standard is worth studying and drawing lessons from, which can provide reference for the scientific supervision of ART and related medical device products in our country and the standard management of assisted reproductive centers, so as to promote the healthy and orderly development in this field.