Embryonic Toxicity Test of Medical Devices for Human Assisted Reproductive Technology.
10.3969/j.issn.1671-7104.2021.06.004
- Author:
Jianfeng SHI
1
;
Rui WANG
1
;
Qianqian HAN
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
biocompatibility evaluation;
blastocyst cell staining and counting;
medical devices for human assisted reproductive technology;
mouse embryo assay
- MeSH:
Humans;
Reproductive Techniques, Assisted;
Toxicity Tests
- From:
Chinese Journal of Medical Instrumentation
2021;45(6):604-607
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference.
METHODS:The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed.
RESULTS:Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD.
CONCLUSIONS:It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.
