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