关键词: 医疗器械, 邻苯二甲酸二-(2-乙基己基)酯, 标准物质, 定值, 气相色谱-质谱联用仪

Abstract:

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 statistics F 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.

Key words: medical devices, di-(2-ethylhexyl) phthalate, reference material, certification, gas chromatography-mass spectrometer