摘要
目的从技术审评角度,研究内窥镜用一次性护套产品。方法基于生产企业和临床机构调研,对内窥镜用一次性护套的结构组成、工作原理、预期用途、风险因素、性能要求和临床要求等六个方面进行了文献和标准研究。结论内窥镜用一次性护套给内窥镜检查提供物理阻挡和隔离,有助于防止交叉感染。从技术审评角度,为保证产品的安全性和有效性,应对其材质、物理化学性能、生物相容性进行严格控制。
Objective To research the safety and efficacy of endoscope sheaths used as protective barriers. Methods Based on field study at manufactures and hospitals, a literature and standards research is carried out focused on the structure, principle, intended use, risk factors, technical performance and clinical trial of the endoscope sheaths. Conclusion The purpose of an endoscope sheath is to provide a covering as physical barrier that helps prevent the cross infection among patients. The safety and efficacy of endoscope sheaths should be assured by strict control of the sheath materials, physical and chemical performance, and biocompatibility.
出处
《中国医疗设备》
2010年第10期8-11,共4页
China Medical Devices
