Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation.
10.3969/j.issn.1671-7104.2020.01.014
- Author:
Ruonan JIN
1
,
2
;
Weigang HE
1
,
2
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing,
2. ##Email#.
- Publication Type:Journal Article
- Keywords:
3D technology;
4K technology;
design elements;
medical endoscope;
technical evaluation
- MeSH:
Endoscopes;
Equipment Design;
Imaging, Three-Dimensional
- From:
Chinese Journal of Medical Instrumentation
2020;44(1):65-67
- CountryChina
- Language:Chinese
-
Abstract:
From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.
