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美國食品藥品監(jiān)督管理局最近提出了監(jiān)管電子霧化裝置上市的PMTA法規(guī)，法規(guī)要求在美國上市的電子霧化裝置產(chǎn)品必須審查化學(xué)品成份，添加劑，尼古丁濃度，毒理學(xué)特征和對人體健康的影響，從而獲得上市許可。同樣，英國的電子霧化裝置制造商或進(jìn)口商也必須嚴(yán)格遵守產(chǎn)品安全法規(guī)，對產(chǎn)品成份和釋放物進(jìn)行毒理學(xué)測試，興奮劑、色素和維生素添加劑受到嚴(yán)格監(jiān)管，以評估對人體健康的影響。

According to Premarket Tobacco Product Applications (PMTA) For ENDS, FDA requires manufacturers and importers submit testing reports of chemicals, additives, Nicotine concentration, and a full toxicological and pharmacological assessment for health risks of new tobacco products. In EU countries, such as UK, manufacturers and importers of E-Cigarettes also need to submit test reports of components, ingredients, additives, and toxicological assessment, according to EU Tobacco Products Directive (TPD) on E-Cigarettes, to assess the public health risks.

因此，全球電子霧化裝置市場對電子煙產(chǎn)品的監(jiān)管均日趨嚴(yán)格，對產(chǎn)品進(jìn)行毒理學(xué)評估成為大勢所趨。天鑒檢測機(jī)構(gòu)以國際認(rèn)可的加拿大衛(wèi)生部毒理測試為標(biāo)準(zhǔn)，已開發(fā)出完善的電子霧化裝置體外毒理學(xué)檢測方法，面向電子霧化裝置各類企業(yè)，提供電子霧化裝置煙油及氣溶膠的體外毒理學(xué)評估測試服務(wù)。

Under the background of more strict supervision of E-Cigarettes marketing in global market, toxicological assessment of ENDS is essential for E-Cigarettes products marketing. As one of the earliest independent testing organizations in E-Cigarettes test field, SKYTE has developed complete in vitro toxicological assessment methods for E-Cigarettes, according to Health Canada official methods.

電子霧化裝置體外毒理學(xué)測試內(nèi)容具體包含：
We can provide E-liquids and aerosol in vitro toxicological assessment services as follows:

主流煙氣樣品的收集。
Preparation and collection of mainstream tobacco smoke for in vitro toxicological assessment.

中性紅試驗(yàn)：用細(xì)胞的半數(shù)致死率來評估受試物毒性。
Neutral Red Uptake Assay. Assess cytotoxicity of test sample by half maximal inhibitory concentration (IC50).

細(xì)菌回復(fù)突變試驗(yàn)：用細(xì)菌的致突變性來評估受試物毒性。
Bacterial Reverse Mutation Assay (Ames Assay). Assess cytotoxicity of test sample by bacterial mutagenicity.

體外微核試驗(yàn)：用細(xì)胞核微核率來評估受試物毒性的報(bào)告。
In Vitro Micronucleus Assay. Assess cytotoxicity of test sample by ratio of micronucleated cells per 1000 observed cells.