医疗器械检测用DEHP标准物质的研究

目的：以邻苯二甲酸二-（2-乙基己基）酯（DEHP）为原料研究制备用于聚氯乙烯类医疗器械检测用的DEHP标准物质。方法：采用气相色谱-质谱联用、红外、核磁共振等技术对原材料进行筛选和考核，对DEHP的含量进行测定，并采用多家实验室协作标定的方式进行定值，进行不确定度评定，及对DEHP标准物质的均匀性和稳定性进行考察。结果：所选择DEHP原料纯度高，量值稳定，含量为99.9%±0.2%；DEHP含量的瓶间和瓶内检测结果差异均无统计学意义（F分别为2.20、0.28，均小于F临界值2.85，P > 0.05）；稳定性试验结果显示分装后12个月DEHP含量无变化，DEHP标准物质在12个月内是稳定的。结论：所制备的DEHP纯度高、不确定度小、均匀性和稳定性良好，适宜作为医疗器械检测用DEHP标准物质。

Evaluation of DEHP reference material for medical devices tests

OBJECTIVE:Evaluation of di-(2-ethylhexyl)phthalate (DEHP) as raw material for preparing DEHP reference material for medical devices tests.METHODS:Identification and determination of purity of DEHP were carried out for the raw material using the gas chromatography-mass spectrometer(GC-MS) area normalization method. The results of calculation of DEHP reference material was obtained through collaboration with several laboratories. Homogeneity and stability were also carried.RESULTS:The selected raw material had high and stable purity. DEHP reference material's purity was 99.9%±0.2%. The homogeneity determination results were:the content results between and in bottles had no statistical difference. The statisticsF was 2.20 and 0.28,which were less than the threshold value F,2.85;P>0.05. The stability determination results were:the DEHP reference material was unchanged and stable in 12 months.CONCLUSION:The above test results showed that the DEHP reference material was homogeneous,stable, and had high purity and low uncertainty. So it was proper to develop it as DEHP reference material for medical devices tests.