Quality Control of Appliance Products of Medical Devices for Human Assisted Reproductive Technology.
10.3969/j.issn.1671-7104.2021.06.002
- Author:
Chongchong LI
1
;
Jingli LI
1
;
Chunren WANG
1
;
Qianqian HAN
1
Author Information
1. National Institutes for Food and Drug Control, Beijing,
- Publication Type:Journal Article
- Keywords:
apparatus products;
human assisted reproductive technology;
medical device;
quality control
- MeSH:
Cross-Sectional Studies;
Humans;
Quality Control;
Reproductive Techniques, Assisted
- From:
Chinese Journal of Medical Instrumentation
2021;45(6):594-598
- CountryChina
- Language:Chinese
-
Abstract:
Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.
