The nickel ion release from NiTi shape memory alloy elastic polymerizer for surgical implants is monitored to provide technical support for safety evaluation of NiTi shape memory alloy bone implants.An inductively coupled plasma mass spectrometry(ICP-MS)method is developed to determine the release of nickel ions from bone implants in vitro.The detection limit of nickel is 0.030 66 ng/mL.The linear relationship is good,the limit of quantitation is 0.919 80 ng/mL,and the RSD(n=6)of nickel element is 0.9％.The average recovery of Ni is 99.4％～104.9％.With the in-crease of nickel-titanium alloy extraction time,the concentration of nickel ions in the test solution increases,and the maximum concentration of nick-el ions in the test solution is 0.053 8 mg/L in 8 months.The method is simple to operate with a low detection limit.The method and data for the de-termination of nickel ion release from NiTi shape memory alloy bone implants are provided,as well as the technical reference for NiTi shape memory alloy products.
关键词
医疗器械/镍离子释放/电感耦合等离子体质谱/镍钛记忆合金
Key words
medical devices/nickel ion release/inductively coupled plasma mass spectrometry/nickel-titanium memory alloy
万方数据