便攜式心電監(jiān)護儀YY1079:2008醫(yī)療器械CMA報告
中檢集團南方測試股份有限公司
2024-02-22 13:51:55








醫(yī)療器械注冊檢驗中檢南方唐小姐(國家級CMA實驗室)
01激光治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-22(要滿足iec60825),GB9706.222(要滿足iec60825或GB7247.1)gb/t14710
02光動力激光治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-22(要滿足iec60825),GB9706.222(要滿足iec60825或GB7247.1)gb/t14710
03光動力治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-57(要滿足iec62471),GB9706.257(要滿足iec62471或GB/T 20145)gb/t14710
04強脈沖光治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-57(要滿足iec62471),GB9706.257(要滿足iec62471或GB/T 20145)gb/t14710注:如果是家用設備,IEC/EN60601-2-57更換為IEC/EN60601-2-83,GB9706.257更換為GB9706.283
05紅光治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-57(要滿足iec62471),GB9706.257(要滿足iec62471或GB/T 20145)gb/t14710注:如果是家用設備,IEC/EN60601-2-57更換為IEC/EN60601-2-83,GB9706.257更換為GB9706.283
06藍光治療設備
IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN60601-2-57(要滿足iec62471),GB9706.257(要滿足iec62471或GB/T 20145)gb/t14710注:如果是家用設備,IEC/EN60601-2-57更換為IEC/EN60601-2-83,GB9706.257更換為GB9706.283


醫(yī)用制氧設備
01醫(yī)用分子篩制氧系統(tǒng) IEC/EN60601-1,GB9706.1,IEC/EN60601-1-6,YY/T9706.106,IEC/EN60601-1-2,YY/T9706.102,IEC/EN80601-2-69,YY9706.269gb/t14710
02醫(yī)用分子篩制氧機 IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106,IEC/EN60601-1-2,YY/T9706.102,IEC/EN80601-2-69,YY9706.269,gb/t14710
03醫(yī)用膜分離制氧系統(tǒng) IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710
04醫(yī)用膜分離制氧機 IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710
05氧氣發(fā)生器 IEC/EN60601-1,GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2,YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710




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關(guān)鍵詞:IEC60601-2-25:1993,GB10793-2000,GB9706.1-2007,IEC60601-1:1988,IDT
唐小輝
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