YY 1139- 2013
GB 9706. 1- 2007
GB 9706. 8- 2009 IDT)
G B 1 0 79 3 - 2000
医用电气设备 第 1部分:安全通用要求(IEC 60601-1:1988,IDT)
医用电气设备 第 2-4部分:心脏除颤器安全专用要求(IEC 60601-2-4:2002,
医用电气设备 第2部分:心电图机安全专用要求(IEC 60601-2-25:1993, IDT)
01心电测量、分析设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-25,GB9706.225IEC/EN60601-2-51,YY0782,YY1139EC11gb/t14710
02动态心电测量、分析设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-47,GB9706.247EC13gb/t14710IEC60601-1-8,YY9706.108
03无创血压测量设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-30,GB9706.230(自动测量）ISO81060-1(非自动）IEC60601-1-11,YY9706.111gb/t14710
04体温测量设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-56,IEC60601-1-11,YY9706.111GB/T21417.1（红外耳温）,GB/T21416（接触型）ASTM E1112.ATM E1965gb/t14710
05脉搏血氧测量设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-61,YY0784，IEC60601-1-11,YY9706.111,YY9706.261gb/t14710
06生理参数诱发诊断设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-40,GB9706.240gb/t14710
06生理参数诱发诊断设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-40,GB9706.240gb/t14710
07有创血压设备
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-34，GB9706.234(自动测量）ISO81060-1(非自动）IEC60601-1-11,YY9706.111gb/t14710
样本分离设备
01医用离心机 IEC/EN61010-1,GB4793.1IEC61010-2-101,YY0648IEC61010-2-081,GB4793.9gb/t14710IEC/EN61326-1,GB/T18268.1IEC/EN61326-2-6,,GB/T18268.26注：如带加热部件，需增加IEC/EN61010-2-010,GB4793.6
02核酸提取纯化仪 IEC/EN61010-1,GB4793.1IEC61010-2-101,YY0648IEC61010-2-081,GB4793.9gb/t14710IEC/EN61326-1,GB/T18268.1IEC/EN61326-2-6,,GB/T18268.26注：如带加热部件，需增加IEC/EN61010-2-010,GB4793.6
温热（冷）治疗设备/器具
01 热传导治疗设备(医用电热毯,褥和垫） IEC/EN60601-1，GB9706.1,IEC/EN60601-1-6,YY/T9706.106,IEC/EN60601-1-2，YY/T9706.102,IEC/EN80601-2-35,YY9706.235gb/t14710
02 热辐射治疗设备IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102YY0306，YY0323(只适合红外）gb/t14710
医用制氧设备
01医用分子筛制氧系统 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医用分子筛制氧机 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医用膜分离制氧系统 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710
04医用膜分离制氧机 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710
05氧气发生器 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-69,YY9706.269gb/t14710
与非血管内导管配套用体外器械
01医用电动吸引器械 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102ISO:10079-1:2015+ A1：2018，YY/T0636.1-2021gb/t14710
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关键词：GB9706.8-2009,GB9706.1-2007,IEC60601-1:1988,IDT,GB10793-2000
