Research on Experimental Model of Security Assessment of DEHP Migration from PVC-Tubes Medical Devices.
10.3969/j.issn.1671-7104.2018.03.018
- VernacularTitle:PVC材料导管类医疗器械DEHP析出的安全评价试验模型研究
- Author:
Yue WANG
1
;
Shiyong BAO
1
;
Guoli SHEN
2
;
Jun WANG
1
;
Hongqiang JIANG
1
Author Information
1. Center for Medical Device Evaluation in Zhejiang Province, Hangzhou, 310009. ##Email#.
2. Zhejiang Crops Hospital of CAPF, Hangzhou, 310051. ##Email#.
- Publication Type:Journal Article
- Keywords:
DEHP;
experimental model;
migration parameters;
security assessment
- MeSH:
Diethylhexyl Phthalate;
adverse effects;
Equipment and Supplies;
Humans;
Models, Theoretical;
Plasticizers;
adverse effects;
Polyvinyl Chloride
- From:
Chinese Journal of Medical Instrumentation
2018;42(3):222-224
- CountryChina
- Language:Chinese
-
Abstract:
As we all know, DEHP is seriously harmful to human health and consequently has been acquired critical attention. DEHP is able to migrate from PVC medical devices for the non-chemically bound to PVC, thus contact with user and patient. The DEHP migration is influenced by various parameters. In order to assess the security of PVC-tubes medical devices scientifically of DEHP migration, we develop an experimental model by analyzing the parameters comprehensively and systematically, taking into account the clinical practices. For example, assessing the security of DEHP migration from infusion sets by utilizing this model.