YY/T 0927-2014 Translated English of Chinese Standard. (YYT 0927-2014, YY/T0927-2014, YYT0927-2014): Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical deviceshttps://www.chinesestandard.net, 13 mar 2016 - 13 pagine This standard provides the chemical analysis methods for release of plasticizer DEHP after medical device which takes PVC as raw material is contacting with liquid of clinical use, under simulation of actual conditions of use. |
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2-ethylhexyl Abundance Time/min Figure add hexane analysis method and/or glucose injection blood or blood chloride injection and/or chromatographic peak components as extract contact manner contact with blood DEHP characteristic ions DEHP in sample DEHP release DEHP standard solution demonstrated and worst Determination of DEHP Determine DEHP devices in contact dialyzer diluted lipid drugs drugs as extract example is shown example of DEHP extract solution preparation extract solvent Take Full scan spectrogram gas chromatography GB/T glucose injection diluted hexane of equivalent infusion of particular inspection solution ion chromatogram TIC liquid chromatography mass spectrometer method mode of gas phthalate DEHP Pre-treatment Preparation of extract PVC devices PVC medical devices regression equation sample solution scan mode scan spectrogram example shown in Figure sodium chloride injection solution Abundance Figure solution as test solution which takes spectrometer method GC/MS Take certain volume take some extract takes ethanol water test solution Total ion chromatogram Unless otherwise specified