Current Progress on Biological Evaluation for Medical Devices.
10.3969/j.issn.1671-7104.2021.01.015
- Author:
Chenghu LIU
1
,
2
,
2
,
3
;
Yanping SHI
1
,
2
,
2
,
3
;
Li HOU
1
,
2
,
2
,
3
;
Xiaoxia SUN
1
,
2
,
2
,
3
Author Information
1. Shandong Quality and Inspection Center for Medical Devices
2. NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging
3. Shandong Provincial Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101.
- Publication Type:Journal Article
- Keywords:
biological evaluation;
medical device;
regulatory science;
risk management
- MeSH:
Equipment and Supplies
- From:
Chinese Journal of Medical Instrumentation
2021;45(1):72-75
- CountryChina
- Language:Chinese
-
Abstract:
To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.
