CAJ | 학술논문

研究镍钛合金医疗器械在进行生物学试验样品制备时,不同浸提条件下制备的浸提液中镍溶出情况,分析不同浸提条件之间是否具有等效性,找到最佳的浸提条件.该实验选用两种品牌的镍钛合金材料,按GB/T 16886-12中推荐的浸提条件对材料进行浸提,采用等离子发射光谱仪对浸提液中镍浓度进行分析.结果发现对于镍钛合金材料,各浸提条件间不具有等效性,建议常规浸提选用(37±1)℃,(72±2) h,加速浸提可选用(70±2)℃,(24±2) h.
연구얼태합금의료기계재진행생물학시험양품제비시,불동침제조건하제비적침제액중얼용출정황,분석불동침제조건지간시부구유등효성,조도최가적침제조건.해실험선용량충품패적얼태합금재료,안GB/T 16886-12중추천적침제조건대재료진행침제,채용등리자발사광보의대침제액중얼농도진행분석.결과발현대우얼태합금재료,각침제조건간불구유등효성,건의상규침제선용(37±1)℃,(72±2) h,가속침제가선용(70±2)℃,(24±2) h.
@@@@The dissolution of nickel from nitinol al oy under different extraction conditions was investigated when biological tests of nitinol medical devices were carried out. It discussed the equivalence of these extraction conditions and found the best extraction conditions. In the experiment, two brands of nitinol were chosen and extracted under different extraction conditions according to GB/T 16886-12. Plasma emission spectrometer was used to analyse the concentration of nickel in extract liquid. The results show that there is no equivalence among these extraction conditions for nitinol materials. And it is suggested that (37±1) ℃, (72±2) h could be used as normal extraction condition and (70±2) ℃, (24±2) h as accelerated extraction condition.