一類醫(yī)療器械隔離衣產(chǎn)品備案資料-5、臨床評價資料(最新整理)

1、隔離衣臨床評價一、產(chǎn)品的預(yù)期用途用于醫(yī)療機構(gòu)門診、病房、檢驗室等作普通隔離。二、產(chǎn)品的預(yù)期使用環(huán)境隔離衣主要應(yīng)用于醫(yī)療衛(wèi)生單位。該產(chǎn)品應(yīng)貯存在相對濕度不超過 80%、溫度為-3055、無腐蝕性氣體、干燥、通風(fēng)良好的室內(nèi)。運輸過程中應(yīng)防止重壓、陽光直曬、雨雪侵淋。3、產(chǎn)品適用人群用于醫(yī)療機構(gòu)門診、病房、檢驗室等需要作普通隔離的人員。4、禁忌癥對非織造布等原材料過敏者慎用。五、已上市同類產(chǎn)品臨床使用情況的比對說明隔離衣主要用于醫(yī)療機構(gòu)門診、病房、檢驗室等作普通隔離。根據(jù)市場調(diào)研及與已上市同類產(chǎn)品臨床使用情況來看，隔離衣制作、使用簡單便捷，已經(jīng)得到廣泛使用。六、同類產(chǎn)品不良事件情況說明根據(jù)現(xiàn)有市場產(chǎn)

2、品，暫無不良事件記錄。我公司已根據(jù)產(chǎn)品的預(yù)期用途/預(yù)期目的和可以預(yù)見的使用錯誤，確認(rèn)了本產(chǎn)品可能發(fā)生的危險：已確認(rèn)設(shè)計中采取了限制和降低產(chǎn)品使用風(fēng)險的措施，產(chǎn)品安全達(dá)到了可以接受的水平?！啊薄啊盿t the end, xiao bian gives you a passage. minand once said, people who learn to learn are very happy people. in every wonderful life, learning is an eternal theme. as a professional clerical and teachin

3、g position, i understand the importance of continuous learning, life is diligent, nothing can be gained, only continuous learning can achieve better self. only by constantly learning and mastering the latest relevant knowledge, can employees from all walks of life keep up with the pace of enterprise development and innovate to meet the needs of the market. this document is also edited by my studio professionals, there may be errors in the do