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卫办监督发[2011]57号各省、自治区、直辖市卫生厅局,新疆生产建设兵团卫生局,中国疾病预防控制中心、卫生部卫生监督中心:经我部组织专家论证,现将《消毒产品卫生安全评价规定》(卫监督发[2009]105号)中“附件1表3抗(抑)菌制剂检验项目及要求”中“注4”修改为:“说明书中标明用于皮肤的抗(抑)菌制剂应进行多次皮肤刺激性试验,于使用后及时清洗的可只进行暴露时间为2小时的急性皮肤刺激试验;说明书中标明用于黏膜的抗(抑)菌制剂应进行眼刺激性试验,用于阴道黏膜的抗(抑)菌制剂还应进行阴道黏膜刺激性试验”。本通知自印发之日起施行。
Health Supervision Bureau of Xinjiang Province Production and Construction Corps, China Disease Prevention and Control Center, Health Supervision Center of Ministry of Health: After the organization of expert testimony by our ministries, the “disinfection products hygiene Safety Evaluation Regulations ”(Wei Supervisory Development [2009] No. 105)“ ”Annex 1 Table 3 anti-(antimicrobial test items and requirements “ 中 ”Note 4 “ amended as follows: ” Skin anti (inhibition) preparations should be repeated skin irritation test, after use in a timely manner to clean the exposure time of only 2 hours of acute skin irritation test; instructions marked mucosal anti (inhibition) Eye irritation test should be carried out, the vaginal mucosa for anti (inhibition) agents should also be vaginal mucosal irritation test ". This notice shall come into effect on the day it is issued.