Study and Analysis on the Test of Representative Products for Percutaneous Renal Puncture Device.
10.3969/j.issn.1671-7104.2019.03.015
- Author:
Lujie JIANG
1
;
Zhongwei ZHENG
2
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
2. Innovex Medical Co. Ltd, Shanghai, 201210.
- Publication Type:Journal Article
- Keywords:
dilator;
laws and regulations;
medical devices;
nephrostomy balloon and set;
percutaneous nephrostomy
- MeSH:
China;
Humans;
Kidney;
Nephrostomy, Percutaneous;
instrumentation;
Punctures
- From:Chinese Journal of Medical Instrumentation
2019;43(3):214-216
- CountryChina
- Language:Chinese
-
Abstract:
Percutaneous renal puncture device has very important clinical value. Qualified percutaneous renal puncture device is one of the important ways to evaluate its safety and efficacy, and it is also an important prerequisite for the device to be marketed in China. When manufactuers test the product, the selection of representative products is suggested from the aspects of performance parameter, structure, material and production process.
