Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 282-285, 2019.
Article
en Zh
| WPRIM
| ID: wpr-772506
Biblioteca responsable:
WPRO
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.
Palabras clave
Texto completo:
1
Índice:
WPRIM
Asunto principal:
Estándares de Referencia
/
Embalaje de Alimentos
/
Medición de Riesgo
/
Equipos y Suministros
/
Fenómenos Toxicológicos
Tipo de estudio:
Etiology_studies
/
Risk_factors_studies
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Año:
2019
Tipo del documento:
Article