中译英

在我国进行的用于角膜制瓣的飞秒激光类设备的临床试验应当满足法规要求。在医疗器械临床试验全过程中，包括方案设计、实施、监查、核查、检查、数据采集、记录、分析总结和报告等，均应遵循《医疗器械临床试验质量管理规范》，并保证临床试验过程规范，结果真实、科学、可靠和可追溯。

临床试验前应该在有资质的检测机构获得产品检测报告。试验用产品必须与检测产品是同一批次或定型的产品，并保证足够的数量。

临床试验前，应该清楚地注明本次试验使用的产品名称、临床试验的意义以及本次试验产品的评价目标，特别是安全性和有效性的评价指标要十分明确。

申请者在开展规范的临床试验前应提供必要的可行性验证资料，包括实验室研究及动物实验等，以证实其基本安全。

        The clinical trials on femto-second laser equipment for flap preparation in refractive surgery should conform to relevant laws and regulations. Throughout the entire process of clinical trials of medical devices, all steps, including protocol design, implementation, monitoring, checking, supervision, data collection, recording, analysis, summary and report, should be done in accordance with the Norms on the Quality Management for the Clinical Trials of Medical Devices. The clinical trials should be performed in a standardized manner and it must be ensured that the results are authentic, scientific, reliable and traceable.

 Before the clinical trials, product test report should be acquired from qualified testing authorities. The product samples used for the clinical trials must be of the same batch or the same model of the products tested and a sufficient amount of products should be ensured.

 Before the clinical trials, the name of the product experimented, significance of the clinical trial and the evaluation goal of the product should be specified. In particular, the evaluation indicators of safety and efficacy should be made very clear.

 Before conducting the standardized clinical trials, the applicants should provide the required feasibility report, which consists of laboratory tests and animal experiments to verify  basic safety of the clinical trials.