Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices.
10.3969/j.issn.1671-7104.2019.04.013
- Author:
Chenghu LIU
1
;
Yanping SHI
1
;
Xiaodan DU
2
;
Xiaoxia SUN
1
;
Jia LIU
1
Author Information
1. Shandong Quality Inspection Center for Medical Devices, Jinan, 250101.
2. National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
biological evaluation;
medical devices;
threshold of toxicological concern (TTC)
- MeSH:
Equipment and Supplies;
standards;
Food Packaging;
standards;
Risk Assessment;
Toxicological Phenomena
- From:
Chinese Journal of Medical Instrumentation
2019;43(4):282-285
- CountryChina
- Language:Chinese
-
Abstract:
The threshold of toxicological concern (TTC), a risk estimation method based on compound structurally-related toxicity data, has been widely used by many countries and regions for the safety risk assessment of food packaging materials and additives etc. Toxicological risk estimation is of importance in the biological evaluation of medical devices. Application of the TTC approach to leachable from medical devices may reduce or replace some unnecessary biocompatibility tests, but consideration should be taken for contact duration and route differences, which could affect the applicability of TTC. We herein focused on analyzing the eligibility of TTC for its further application in biological evaluation of medical devices.
