PEG-20M毛細(xì)管柱測定 高分子材料浸提液中環(huán)氧乙烷遷移量

，峰面積定量

高分子材料浸提液中環(huán)氧乙烷遷移量 測試譜圖：




Migration of ethylene oxide in polymer material extract
Migration amount of ethylene oxide in polymer material extracting solution Details:

Name: Capillary Column
Specification: 30m*0.32mm*0.5um
Model: PEG-20M
Application: Implantable medical devices, Polymer materials, Determination of toxic and hazardous substances in extracts. Part 10: Migration of ethylene oxide, Gas chromatography

1 Scope
This standard specifies the gas chromatography of ethylene oxide migration in polymer material extracts of implantable medical devices sterilized by ethylene oxide
Method of determination.
This standard applies to the determination of the migration of ethylene oxide in polymer material extracts of implantable medical devices sterilized by ethylene oxide.
The detection limit of ethylene oxide in this method is 0.1 mg/L.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 6682 Analytical laboratory water specifications and experimental methods
GB/T 16886.12 Biological evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
3 Principles of the method
Place the sample to be tested in a closed container, and heat it up to make the volatile components volatilize from the sample matrix.
When the phases reach equilibrium, the gas in the headspace is directly extracted for gas chromatographic analysis. Qualitative by retention time, quantification by peak area, using external standard
Quantitative


Test spectrum of ethylene oxide migration in polymer material extract: