Electrical Equipment For Measurement, Control ,and Laboratory Use
IEC/EN 61010-1
GB4793.1
2
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求
Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm
IEC/EN 61010-2-101
YY 0648
3
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes
IEC/EN 61010-2-081
GB4793.9
4
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求
Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements
IEC/EN 61326-1
GB/T 18268.1
5
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断
Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC/EN 61326-2-6
GB/T18268.26
医用电器设备检测标准/Medical Device testing standards list
序号
名称
国际标准
国内标准
1
医用电气设备 第2部分 心电图机安全专用要求
Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements
IEC/EN 60601-2-25
GB 10793
2
无创血压计第1部分:通用要求
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
EN ISO /ISO 81060-1
3
无创血压计.第3部分:电-机血压测量系统的补充要求
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 1060-3
4
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求
Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC/EN 60601-1-1
GB 9706.15
5
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC/EN 60601-2-27
GB 9706.25
7
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs
IEC/EN 60601-2-26:2012
IEC 80601-2-26：2019
GB 9706.26
8
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement
ISO/ EN ISO 80601-2-56
9
血压计Non-invasive automated sphygmomanometers
ANSI/AAMI SP10
YY 0670
10
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC/EN 60601-2-57
11
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories
IEC/EN/EN IEC 60601-2-2
GB 9706.4
12
医用电气设备第1部分：安全通用要求
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ANSI/AAMI ES60601-1
EN /IEC60601-1
GB9706.1
13
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators
IECC/EN 60601-2-10
YY 0607
14
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
IEC/EN 80601-2-30
YY 0667
15
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment
IEC/EN 60601-2-49/IEC 80601-2-49
YY 0668
16
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment
EN ISO 9919
ISO / EN ISO 80601-2-61
YY 0784
18
医用电气设备 第2-38部分:医院电动床安全专用要求
医用电气设备 第2-52部分:医院电动床安全专用要求 Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds
IEC/EN 60601-2-52
YY 0571
19
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求
Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs
