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醫(yī)療保健產(chǎn)品滅菌環(huán)氧乙烷殘留測定
醫(yī)療保健產(chǎn)品滅菌環(huán)氧乙烷殘留測定 詳細信息：

名稱：填充柱
固定相：高分子小球
粒度：60-80目
規(guī)格：1-2m*內(nèi)徑2-3mm
型號：Porapak Qs
應用：
GB 18281.2-2000 醫(yī)療保健產(chǎn)品滅菌 生物指示物 第2部分：環(huán)氧乙烷滅菌用生物指示物

浩瀚色譜（山東）應用技術開發(fā)有限公司建立氣相色譜法檢測口罩、防護服等醫(yī)療防護用品中環(huán)氧乙烷的殘留量,為生產(chǎn)廠家改進滅菌工藝提供數(shù)據(jù)支持。氣相色譜法采用頂空進樣、FID檢測器,環(huán)氧乙烷的質(zhì)量濃度在0.5～8 μg/mL范圍內(nèi)與色譜峰面積線性關系良好,檢出限為0.10 μg/g,定量限為0.35 μg/g。環(huán)氧乙烷測定結(jié)果的相對標準偏差為1.73%（n=6）,平均加標回收率為94.3%～99.3%。該方法操作簡便,精密度、準確度較高,適用于醫(yī)療防護用品中環(huán)氧乙烷的測定。


醫(yī)療保健產(chǎn)品滅菌環(huán)氧乙烷殘留測定  測試譜圖：



Determination of Sterilized Ethylene Oxide Residues in Healthcare Products
Sterilization Ethylene Oxide Residue Determination of Healthcare Products Details:

Name: Packed Column
Stationary phase: polymer beads
Granularity: 60-80 mesh
Specifications: 1-2m* inner diameter 2-3mm
Model: Porapak Qs
application:
GB 18281.2-2000 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for sterilization of ethylene oxide

GB 18281.2-2015 Sterilization of Healthcare Products - Ethylene Oxide - Part 1: Requirements for the Development, Validation and Routine Control of the Sterilization Process for Medical Devices
GB 18281.2-2015 Sterilization of Health Care Products   Biological Indicators   Part 2: Biological Indicators for Ethylene Oxide Sterilization

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a gas chromatography method to detect the residual amount of ethylene oxide in medical protective equipment such as masks and protective clothing, and provide data support for manufacturers to improve the sterilization process. Gas chromatography adopts headspace injection and FID detector. The mass concentration of ethylene oxide has a good linear relationship with the chromatographic peak area in the range of 0.5-8 μg/mL. The detection limit is 0.10 μg/g, and the quantification limit is 0.35. μg/g. The relative standard deviation of the determination results of ethylene oxide was 1.73% (n=6), and the average recovery was 94.3%-99.3%. The method is easy to operate, has high precision and accuracy, and is suitable for the determination of ethylene oxide in medical protective equipment.


Determination of Sterilized Ethylene Oxide Residues in Healthcare Products Test Spectrum:


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