[The cytotoxicity study of sterile urethral catheter for single use].
To further demonstrate the toxicity of the catheter, cytotoxicity evaluation was conducted in registration inspection products and the relationship between testing methods and materials were analyzed. This result showed that to strengthen cytotoxicity assay in registration inspection is important to choose catheter in clinic.
State Food and Drug Administration Jinan Quality Supervision and Inspection Center for Medical Devices, Key Lab of Biological Evaluation of Medical Devices of Shandong Province, Jinan. 521keren@sina.com
Li
L
Hou
Dongming
D
Zeng
Xin
X
Wang
Xiue
X
Zheng
D002478:Cells, Cultured; D003603:Cytotoxins / Q000633:toxicity*; D004209:Disposable Equipment; D006801:Humans; D008422:Materials Testing; D062885:Urinary Catheters / Q000009:adverse effects*
D003603:Cytotoxins