ISO14155:2011标准简介及其在我国应用前景的展望

Brief Introduction of ISO 14155:2011 and Prospects for its Application in China

医疗器械新产品在上市以前,为了确认产品安全有效,一般应对其进行临床研究。世界各国对如何进行医疗器械临床研究的要求都是非常严格的,如FDA、欧盟和我国的监管部门等都已颁布了医疗器械临床研究的相关法规或指令。ISO14155标准是用于世界范围内医疗器械的临床研究标准,其主要内容是评价医疗器械在人体应用的安全性并确认其使用的有效性。ISO 14155:2011是医疗器械临床研究的临床质量管理规范(GCP),与前版标准相比,新版标准内容更加丰富,要求更高,实用性和可操作性更强。因此,其在我国也将具有良好的应用前景。

In order to confirm their safety and performance,the clinical investigations shall be designed,conducted,recorded and reported on the premarketing investigations for medical devices.The requirements on how to conduct the clinical investigations for medical devices are very strict from all over the wold.For example,FDA,regulatory authorities of EC and China have also released the regulatory requirements or directives related to the clinical investigations for medical devices.ISO 14155 standard is a worldwide-used clinical investigation standard for medical devices,which mainly devotes to evaluating the safety of medical devices applied to human body and confirms their effectiveness.Actually,ISO 14155：2011 addresses good clinical practices for the clinical investigations of medical devices.In contrast to the former edition,ISO14155：2011 has been richer in contents,higher requirements and stronger operability.It therefore has good application prospects in China.