[Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices]

Chenghu Liu; Yanping Shi; Xiaodan Du; Xiaoxia Sun; Jia Liu

doi:10.3969/j.issn.1671-7104.2019.04.013

[Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices]

Zhongguo Yi Liao Qi Xie Za Zhi. 2019 Jul 30;43(4):282-285. doi: 10.3969/j.issn.1671-7104.2019.04.013.

[Article in Chinese]

Authors

Chenghu Liu^{1

2}, Yanping Shi^{1

2}, Xiaodan Du³, Xiaoxia Sun^{1

2}, Jia Liu^{1

2}

Affiliations

¹ Shandong Quality Inspection Center for Medical Devices, Jinan, 250101.
² Shandong Key Laboratory for Biological Evaluation of Medical Devices, Jinan, 250101.
³ National Institutes for Food and Drug Control, Beijing, 102629.

PMID: 31460722
DOI: 10.3969/j.issn.1671-7104.2019.04.013

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.

Keywords: biological evaluation; medical devices; threshold of toxicological concern (TTC).

MeSH terms

Equipment and Supplies* / standards
Food Packaging* / standards
Risk Assessment
Toxicological Phenomena