灭菌是确保医liao器械安全性和有效性的有效途径。环氧乙烷（ethylene oxide，EO）具有广谱高效杀菌作用，且成本较低、穿透性强，属目前常用的高效化学低温灭菌剂之一 ，在一次性使用无菌yi疗器械灭菌中被广泛应用 。但 EO 具有致突变性、胎儿毒性和致畸特性，且对睾丸功能具有不良作用，并能对人体多个器官系统产生损害 。且在医liao器械的生产、灭菌、存储、运输、使用等环节中，EO 残留物会生成其他副产物。
      残留的 EO 可发生水解，进而与产品或环境中的氯离子反应生成2- 氯乙醇（ethylene chlorohydrin，ECH）。而 ECH同样具有致突变性、胎儿毒性和致畸特性，并可损害人体的肺、肾、中枢神经系统和心血管系统 。因此，对采用 EO 灭菌的一次性使用无菌yi疗器械产品中 EO 和 ECH 的残留量进行检测具有重要意。

浩瀚色谱(山东)应用技术开发有限公司，研制的《聚氯乙烯输注器具中2-氯乙醇测定色谱柱》，柱效高，分离好，在安捷伦，岛津，赛默飞，瓦里安，布鲁克，PE上使用，效果良好，结果满意。
 

名称：毛细管柱

固定相：6%氰丙基/苯基-94%二甲基聚硅氧烷

规格：30m*0.25mm*1.4um

型号：HH-624

应用：YYT1690-2020 一次性使用聚氯乙烯输注器具中2-氯乙醇残留量测定方法

 

适用于：

安捷伦490在线/便携，4890,5890,6890,7820,7890,8860,8890

岛津GC-14C，GC-2010，GC-2014，GC-2030

赛默飞1310,1300,1610,1600

瓦里安3800系列

布鲁克PE580,590,680,690

磐诺A90，福立GC9790，华爱，天瑞，天美，GC7900，川仪，北分瑞利，东西电子，鲁南瑞虹，捷岛/科晓


 

Sterilization is an effective way to ensure the safety and effectiveness of medical devices. Ethylene oxide (EO) has a broad-spectrum and highly efficient bactericidal effect, with low cost and strong penetration. It is one of the commonly used high-efficiency chemical low-temperature sterilizers and is widely used in the sterilization of disposable sterile medical devices. However, EO has mutagenic, fetal toxic, and teratogenic properties, and has adverse effects on testicular function, as well as causing damage to multiple organ systems in the human body. In the production, sterilization, storage, transportation, and use of medical devices, EO residues can generate other by-products.
Residual EO can undergo hydrolysis and react with chloride ions in the product or environment to produce 2-chloroethanol (ECH). ECH also has mutagenic, fetal toxicity, and teratogenic properties, and can damage the lungs, kidneys, central nervous system, and cardiovascular system of the human body. Therefore, it is of great significance to detect the residual levels of EO and ECH in disposable sterile medical device products sterilized with EO.
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has developed a chromatographic column for the determination of 2-chloroethanol in polyvinyl chloride infusion equipment, which has high column efficiency and good separation. It has been used on Agilent, Shimadzu, Thermo Fisher, Varian, Brooke, and PE with good results and satisfactory outcomes.
Name: Capillary Column
Fixed phase: 6% cyanopropyl/phenyl-94% dimethyl polysiloxane
Specification: 30m * 0.25mm * 1.4um
Model: HH-624
Application: YYT1690-2020 Determination method for residual 2-chloroethanol in disposable polyvinyl chloride infusion equipment
Suitable for:
Agilent 490 online/portable, 48905890689088608890
Shimadzu GC-14C, GC-2010, GC-2014, GC-2030
Thermo Fisher Scientific 1310130016101600
Varian 3800 Series
Brooke PE580590680690
Panno A90, Fuli GC9790, Huaai, Tianrui, Tianmei, GC7900， Chuanyi, Beifen Ruili, Dongxi Electronics, Lunan Ruihong, Jiedao/Kexiao