| 付步芳,王春仁.医疗器械检测用2-氯乙醇标准物质的研究[J].中国药事,2017,(8):944-950 |
| 医疗器械检测用2-氯乙醇标准物质的研究 |
| Study of Ethylene Chlorohydrin Reference Material for Medical Device Testing |
| 投稿时间：2017-02-12 |
| DOI：10.16153/j.1002-7777.2017.08.019 |
| 中文关键词: 医疗器械 2-氯乙醇 标准物质 均匀性试验 稳定性试验 |
| 英文关键词: medical device ethylene chlorohydrin reference material homogeneity test stability test |
| 基金项目:国家科技支撑计划重点专项（编号2012BA122B01） |
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| 中文摘要: |
| 目的：以2-氯乙醇（Ethylene Chlorohydrin，ECH）为原料制备用于医疗器械检测用的ECH标准物质。方法：采用气相色谱质谱连用技术对原材料进行筛选和考核，采用气相色谱技术对ECH标准物质的含量进行测定，采用多家实验室协作标定的方式进行定值，并进行不确定度评定，另对ECH标准物质的均匀性和稳定性进行了考察。结果：所研制的ECH标准物质原料纯度高，量值稳定，ECH含量为97.92%±0.02%；均匀性考察结果：ECH含量的统计量F=0.70，小于F（0.05）临界值2.76；稳定性试验结果表明ECH标准物质在12个月时纯度的相对标准偏差RSD是0.46%。结论：所研制的ECH标准物质纯度高，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ECH标准物质。 |
| 英文摘要: |
| Objective: To prepare ethylene chlorohydrin (ECH) reference material for medical device testing using ECH as raw material. Methods: The purity of the raw material was screened and checked using gas chromatography-mass spectrometer (GC-MS). The content of the ECH reference material was measured using the method of gas chromatography (GC). The results of calculation of ECH reference material was obtained through collaboration with several laboratories and the homogeneity and stability were also tested. Results: The ECH reference material had high and stable purity. The content of the ECH reference material was 97.92% ±0.02%. The homogeneity result showed that the statistics F was 0.70, which was less than the threshold value F(0.05)=2.85. The stability result showed that the relative standard deviation (RSD) of the ECH reference substance at 12 months was 0.46%. Conclusion: The prepared ECH reference material was homogeneous, stable, with high purity and low uncertainty, which was suitable as ECH reference substance for medical device testing. |
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