试剂与材料

除另有规定外，所用的试剂应为优级纯，试验用水应符合GB/T 6682规定的二级水的要求。

环氧乙烷标准品：环氧乙烷国际标准品（50 000 mg/L）或环氧乙烷标准气体。

5 试剂配制

5.1 环氧乙烷贮备液制备：如使用环氧乙烷国际标准品制备，则颠倒混匀环氧乙烷国际标准品，取

1.0 mL 加入预先加入超纯水的 100 mL 容量瓶，定容 100 mL， 2℃～8℃储存。浓度：500 μ g/mL。

5.2 如使用环氧乙烷标准气体制备贮备液，取外部干燥的 50 mL 容量瓶，加入约 30 mL 水，加瓶塞，

精确称重。用注射器注入约 0.6 mL 环氧乙烷，不加瓶塞，轻轻摇匀，改好瓶塞，称重，前后两次称重

之差，即为溶液中所含环氧乙烷重量。加水刻度制成约含环氧乙烷 10 mg/mL 的溶液，作为标准贮备

液


植入材料浸提液中环氧乙烷迁移量  测试谱图：




Migration of ethylene oxide in the extract of implant material
Migration of ethylene oxide in the extract of implant material Details:

Name: Capillary Column
Specification: 30m*0.53mm*1.0um
Model: HH-FFAP
Application: Implantable medical devices, Polymer materials, Determination of toxic and hazardous substances in extracts. Part 10: Migration of ethylene oxide, Gas chromatography


Reagents and materials
Unless otherwise specified, the reagents used should be pure superior grade, and the test water should meet the requirements of secondary water specified in GB/T 6682.
Ethylene oxide standard: ethylene oxide international standard (50 000 mg/L) or ethylene oxide standard gas.
5 Reagent preparation
5.1 Preparation of ethylene oxide stock solution: if the international standard ethylene oxide is used for preparation, mix the international standard ethylene oxide upside down and take
Add 1.0 mL to a 100 mL volumetric flask pre-filled with ultrapure water, dilute to 100 mL, and store at 2℃～8℃. Concentration: 500 μg/mL.
5.2 If you use ethylene oxide standard gas to prepare the stock solution, take an externally dry 50 mL volumetric flask, add about 30 mL water, and add a stopper.
Accurate weighing. Use a syringe to inject about 0.6 mL of ethylene oxide, without the cork, shake it gently, change the cork, weigh, and weigh twice before and after
The difference is the weight of ethylene oxide contained in the solution. Add water to the mark to make a solution containing about 10 mg/mL of ethylene oxide, as a standard stock
liquid


Test spectrum of ethylene oxide migration in the extraction solution of implant material: