Discussion on Key Points of Technical Evaluation of Incision Protection Sheath Products
REN Yongcheng1, WAN Ximing2, ZHANG Wei2, QIAO Xiaofang1, AN Wei1
1. Henan Provincial Food and Drug Evaluation Inspection Center, Zhengzhou Henan 450018, China;
2. Henan Medical Device Testing Institute, Zhengzhou Henan 450018, China
Abstract：We first introduced the general situation of the incision protective sleeve products of the second type of medical devices,
including the registration situation, management category, etc., and then summarized and analyzed the technical evaluation
requirements and concerns of the incision protective sleeve products in this paper, in order to provide technical guidance for the applicants
to register the incision protection sheath products, and also provide technical reference for the medical device technical evaluation
department to review the registration declaration data.
任永成1，万锡铭2，张伟2，乔晓芳1，安维1. 切口保护套产品技术审评要点的探讨[J]. 中国医疗设备, 2019, 34(10): 164-167.
REN Yongcheng1, WAN Ximing2, ZHANG Wei2, QIAO Xiaofang1, AN Wei1. Discussion on Key Points of Technical Evaluation of Incision Protection Sheath Products. China Medical Devices, 2019, 34(10): 164-167.
