Abstract:

Objective The biological safety of a new developed silicone rubber for inflatable silastic prosthesis (SRISP)was evaluated. Methods Following the GB/T 16886.10-2005 standard, YY/T 0127.13-2009 standard, and GB/T 16886.11-2011 standard, samples were prepared and tested by animal experiments, such as guinea pig maximization test, oral mucousmembrane irritation test, and short-term systemic toxicity test (oral route). Results No obvious erythema and edema in theguinea pig abdominal skin were observed after 24, 48, and 72 h of stimulating touch, thus indicating that SRISP does notcause potential skin sensitivity. No local response to SRISP was found, and the visual observation and pathological findingsof oral mucosa were normal and similar to that of the control group. Therefore, SRISP had no irritation response to oralmucosa. No clinical signs of toxicity were observed in rats, and no significant differences in weight and weight relativegrowth rate between extract group and blank control group (P>0.05) were found. Thus, SRISP had no short-term systemictoxicity. Conclusion These results indicated that SRISP met the requirement of biomedical materials and had good biosecurity.

Key words: silicone rubber, prosthesis, biological safety