IEC-60601-标准信息.docx

IEC 60601 标准信息（红色的为不再使用的信息）2011.11.08整理
序号
标准号
标准名称
对应国内标准
标准中文名称
备注
一
IEC 60601-1系列

1
IEC 3.0
60601-1-2005
Medical electrical equipment—Part1 General requirements for basic safety and essential performance
GB9706.1
医用电气设备：安全性的一般技术要求
现行第二版
（2012.6.1失效）
1
IEC 2.0
60601-1-1-2000
Medicalelectricalequipment—part1generalrequirementsforsafety—collateralstandard—safetyrequirementsformedicalelectricalsystems
GB9706.15
医用电气设备：第1-1部分：医疗电气系统的安全性要求

2
IEC 3.0
60601-1-2-2007
Medicalelectricalequipment—Part1-2Generalrequirementsforbasicsafetyandessentialperformance—collateralstandardelectromagneticcompatibility—Requirements and tests
YY0505
医用电气设备：第1-2部分：电磁相容性技术要求和测试
现行第二版
（2012.6.1失效）
3
IEC 3.0
60601-1-3-2008
Medicalelectricalequipment—Part1-3:Generalrequirementsforsafety—Collateralstandard:generalrequirementsforradiationprotectionindiagnosticx-ray equipment
GB9706.12
医用电气设备第1-3部分：通用安全要求—并行标准：诊断用X射线设备辐射保护通用要求
现行第三版
（2012.6.1失效）
4
IEC 1.1
60601-1-4-2000
Medicalelectricalequipment—Part1-4Generalrequirementsforsafety—collateralstandardprogrammableelectricalmedicalsystems
YY/T0708
医用电气设备第1-4部分：安全的一般要求并行的标准：可程序化的医用电气设备

5
IEC 60601-1-5
Medicalelectricalequipment–Part1-5:Generalrequirementsforbasicsafety-Collateral standard: image quality and dose for x-ray equipment

医用电气设备第1-5部分：通用安全要求—并行标准：X射线设备成像质量与剂量安全通用要求
不再使用
6
IEC3.0
60601-1-6-2010
Medicalelectricalequipment–Part1-6:Generalrequirementsforbasicsafetyandessentialperformance–collateralstandard:Usability
GBT 21051
医用电气设备.第1-6部分:安全的通用要求.附属标准:使用性
现行第二版
（2012.6.1失效
7
IEC 60601-1-7
Medicalelectricalequipment–Part1-7:Generalrequirementsformultiparameter monitors

医用电气设备.第1-7部分:多参数显示器的安全通用要求
不再使用
8
IEC2.0
60601-1-8-2006
Medicalelectricalequipment–Part1-8:Generalrequirementsforbasicsafetyandessentialperformance–collateralstandard:Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystem
YY0709
医用电气设备.第1-8部分:安全的一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南
现行第二版
（2012.6.1失效
9
IEC1.0
60601-1-9-2007
Medicalelectricalequipment—Part1-9Generalrequirementsforbasicsafetyandessentialperformance—collateralstandardrequirementsforenvironmentallyconscious

医用电气设备.第1-9部分:安全的一般要求.并行标准：环境意识基本安全和性能通用要求

10
IEC1.0
60601-1-10-2007
Medicalelectricalequipment–Part1-10:Generalrequirements forbasicsafetyandessentialperformance–collateralstandard: Requirementsforthedevelopmentofphysiologicclosed-loop controllers

医用电气设备：第1-10部分：基本安全和性能通用要求并行标准:生理闭环控制器开发要求

11
IEC1.0
60601-1-11-2010
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

医用电气设备：第1-11部分：基本安全和性能通用要求并行标准:家庭健康护理使用医用电气系统要求

二
IEC 60601-2系列

1
IEC3.0
60601-2-1-2009
Medical electrical equipment - part 2-1: particular requirements for the safety of electron accelerators in the range 1 mev to 50 mev
GB9706.5
医用电气设备 第2部分：能量为1MeV至50 MeV电子加速器安全专用要求

2
IEC5.0
60601-2-2-2009
Medical electrical equipment - part 2-2: particular requirements for the safety of high frequency surgical equipment
GB9706.4
医用电气设备 第2-2部分：高频手术设备安全专用要求
现行第五版
（2012.4.1失效
3
IEC2.0
60601-2-3-1998 amd
Medical electrical equipment part 2-3: particular requirements for the safety of short-wave therapy equipment
YY91086 YY91087

已于2011.7.1失效
4
IEC3.0
60601-2-4-2010
Medical electrical equipment - part 2-4: particular requirements for the basic safety and essential performance of cardiac defibrillators
GB9706.8
医用电气设备　第2-4部分：心脏除颤器安全专用要求

5
IEC3.0
60601-2-5-2009
Medical electrical equipment - part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
GB9706.7
医用电气设备 第2-5部分：超声理疗设备安全专用要求

6
IEC1.0
60601-2-6-1984
Medical electrical equipment - part 2: particular requirements for the safety of microwave therapy equipment
GB9706.6
医用电气设备 第二部分：微波治疗设备安全专用要求
不再使用？
7
IEC2.0
60601-2-7-1998
Medical electrical equipment - part 2-7: particular requirements for the safety of high-voltage generators of diagnostic x-ray generators
GB9706.3
医用电气设备 第2部分:诊断X射线发生装置的高压发生器安全专用要求

8
IEC2.0
60601-2-8-2010
Medical electrical equipment - part 2-8: particular requirements for the basic safety and essential performance of therapeutic x-ray equipment operating in the range 10 kv to 1 mv
GB9706.10

医用电气设备 第二部分:治疗X射线发生装置安全专用要求

9
IEC1.0
60601-2-9-1996
Medical electrical equipment - part 2-9: particular requirements for the safety of patient contact dosemeters used in radiotherapy withelectrically connected radiation detectors
GB9706.21
医用电气设备 第2部分:用于放射治疗与患者接触且具有电气连接辐射探测器的剂量计的安全专用要求
不再使用
10
IEC1.0
60601-2-10-2001 am1
Medical electrical equipment part 2-10: particular requirements for the safety of nerve and muscle stimulators
YY0607
医用电气设备 第2部分：神经和肌肉刺激器安全专用要求
已于2004.11.1失效
11
IEC2.0
60601-2-11-2004 am1
Medical electrical equipment part 2-11: particular requirements for the safety of gamma beam therapy equipment
GB9706.17
医用电气设备 第2部分：γ射束治疗设备安全专用要求

12
IEC2.0
60601-2-12-2001
Medical electrical equipment - part 2-12: particular requirements for the safety of lung ventilators for medical use
GB9706.28
医用电气设备 第2部分: 呼吸机安全专用要求 治疗呼吸机

13
IEC3.1
60601-2-13-2009
Medical electrical equipment - part 2-13: particular requirements for the safety of anaesthetic workstations
GB9706.29
医用电气设备 第2-13部分：麻醉系统的安全和基本性能专用要求

14
IEC1.0
60601-2-14-1989
Medical electrical equipment - part 2-14: particular requirements for the safety of electroconvulsive therapy equipment

不再使用
15
IEC1.0
60601-2-15-1988
Medical electrical equipment - part 2-15: particular requirements for the safety of capacitor discharge x-ray generators

不再使用
16
IEC3.0
60601-2-16-2008
Medical electrical equipment - part 2-16: particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GB9706.2
医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的安全专用要求

17
IEC2.0
60601-2-17-2004
Medical electrical equipment - part 2-17: particular requirements forthe safety of remote-controlled automatically driven gamma-ray after-loading equipment
GB9706.13
医用电气设备 第2-17部分：自动控制式近距离治疗后装设备安全专用要求
已于2007.3.1失效
18
IEC3.0
60601-2-18-2009
Medical electrical equipment part 2-18: particular requirements for the safety of endoscopic equipment
GB9706.19
医用电气设备 第2-18部分:内窥镜设备安全专用要求

19
IEC2.0
60601-2-19-2009
Medical electrical equipment - part 2-19: particular requirements of safety of baby incubators
GB11243
医用电气设备 第2-19部分：婴儿培养箱安全专用要求
2012.4.1失效
20
IEC2.0
60601-2-20-2009
Medical electrical equipment - part 2-20: particular requirements for the safety of infant transport incubators

医用电气设备 第2-20部分：婴儿运输培养箱安全专用要求
2012.9.1失效
21
IEC2.0
60601-2-21-2009
Medical electrical equipment part 2-21: particular requirements for the safety of infant radiant warmers
YY0455
医用电气设备第2-21部分：婴儿辐射保暖台安全专用要求
2012.4.1失效
22
IEC3.0
60601-2-22-2007
Medical electrical equipment - part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
GB9706.20
医用电气设备 第2-22部分:诊断和治疗激光设备安全专用要求

23
IEC3.0
60601-2-23-2011
Medical electrical equipment - part 2-23: particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

24
IEC1.0
60601-2-24-1998
Medical electrical equipment - part 2-24: particular requirements for the safety of infusion pumps and controllers
GB9706.27
医用电气设备 第2-24部分:输液泵和输液控制器安全专用要求

25
IEC2.0
60601-2-25-2011
Medical electrical equipment - part 2-25: particular requirements for the safety of electrocardiographs
GB10793
医用电气设备第2部分：心电图机安全专用要求

26
IEC2.0
60601-2-26-2002
Medical electrical equipment part 2-26: particular requirements for the safety of electroencephalographs
GB9706.26
医用电气设备 第2部分:脑电图机安全专用要求
已于2006.3.1失效
27
IEC3.0
60601-2-27-2011
Medical electrical equipment - part 2-27: particular requirements for the safety of electrocardiographic monitoring equipment
GB9706.25
医用电气设备 第2部分:心电监护设备安全专用要求

28
IEC2.0
60601-2-28-2010
Medical electrical equipment - part 2-28: particular requirements for the basic safety and essential performance of x-ray tube assemblies for medical diagnosis
GB9706.11
医用电气设备 第2部分:医用诊断X射线源组件和X射线管组件安全专用要求
2013.4.1失效
29
IEC3.0
60601-2-29-2008
Medical electrical equipment - part 2-29: particular requirements for the basic safety and essential performance of radiotherapy simulators
GB9706.16
医用电气设备 第2部分:放射治疗模拟机安全专用要求
已于2011.11.1失效
30
IEC2.0
60601-2-30-1999
Medical electrical equipment - part 2-30: particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
YY0667
医用电气设备 第2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
已于2003.2.1失效
31
IEC2.1
60601-2-31-2011
Medical electrical equipment - part 2-31: particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

32
IEC1.0
60601-2-32-1994
Medical electrical equipment part 2-32: particular requirements for the safety of associated equipment of x-ray equipment
GB9706.14
医用电气设备 第2部分:X射线设备附属设备安全专用要求

33
IEC3.0
60601-2-33-2010
Medical electrical equipment - part 2-33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
YY0319
医用电气设备 第2-33部分：医疗诊断用磁共振设备安全专用要求

34
IEC3.0
60601-2-34-2011

Medical electrical equipment - part 2-34: particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

YY0783
医用电气设备 第2-34部分：有创血压监测设备的安全和基本性能专用要求

35
IEC1.0
60601-2-35-1996
Medical electrical equipment - part 2-35: particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

电热毯、衬垫、褥垫
不再使用？
36
IEC1.0
60601-2-36-1997
Medical electrical equipment - part 2-36: particular requirements forthe safety of equipment for extracorporeally induced lithotripsy
GB9706.22
医用电气设备 第2-36部分: 体外引发碎石设备安全专用要求

37
IEC2.0
60601-2-37-2007
Medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
GB9706.9
医用电气设备 第2-37部分：超声诊断和监护设备安全专用要求
已于2010.10.1失效
38
IEC1.0
60601-2-38-1999
Medical electrical equipment - part 2-38: particular requirements for the safety of electrically operated hospital beds
YY0571
医用电气设备 第2部分：医院电动床安全专用要求
已于2003.1.1失效
39
IEC2.0
60601-2-39-2007
Medical electrical equipment - part 2-39: particular requirements for basic safety and essential performance of peritoneal dialysis equipment
GB9706.39

医用电气设备 第2-39部分：腹膜透析设备的安全专用要求

已于2011.3.1失效
40
IEC1.0
60601-2-40-1998
Medical electrical equipment - part 2-40: particular requirements for the safety of eletromyographs and evoked response equipment

肌电图及激发响应设备

41
IEC2.0
60601-2-41-2009
Medical electrical equipment - part 2-41: particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
YY0627
医用电气设备第2部分：手术无影灯和诊断用照明灯安全专用要求
2012.11.1失效
42
60601-2-42
Medical electrical equipment - part 2-42: particular requirements for the safety of automatic or advisory external defibrillators.

外部除颤器
不再使用
43
IEC2.0
60601-2-43-2010
Medical electrical equipment - part 2-43: particular requirements for the basic safety and essential performance of x-ray equipment for interventional procedures
GB9706.23
医用电气设备 第2-43部分:介入操作 X射线设备安全专用要求
2013.6.1失效
44
IEC3.0
60601-2-44-2009
Medical electrical equipment - part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
GB9706.18
医用电气设备 第2部分：X射线计算机体层摄影设备安全专用要求
2012.5.1失效
45
IEC3.0
60601-2-45-2011
Medical electrical equipment - part 2-45: particular requirements for the basic safety and essential performance of mammographic x-ray equipment and mammographic stereotactic devices
GB9706.24

医用电气设备 第2-45部分:乳腺X射线摄影设备及乳腺摄影立体定位装置 安全专用要求

46
IEC2.0
60601-2-46-2010
Medical electrical equipment - part 2-46: particular requirements for the basic safety and essential performance of operating tables
YY0570
医用电气设备 第2部分：手术台安全专用要求

47
IEC1.0
60601-2-47-2001
Medical electrical equipment - part 2-47: particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

移动心电图

48

60601-2-48
Medical electrical equipment - part 2-48: particular requirements for the safety of radiation therapy treatment planning systems

放射治疗计划系统
不再使用
49
IEC2.0
60601-2-49-2011
Medical electrical equipment - part 2-49: particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
YY0668
医用电气设备 第2部分：多参数患者监护设备安全专用要求

50
IEC2.0
60601-2-50-2010
Medical electrical equipment - part 2-50: particular requirements for the basic safety and essential performance of infant phototherapy equipment
YY0669
医用电气设备 第2部分：婴儿光治疗设备安全专用要求
2012.5.1失效
51
IEC1.0
60601-2-51-2003
Medical electrical equipment - part 2-51: particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
YY0782
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

52
IEC1.0
60601-2-52-2009
Medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds

医用电动床
2013.4.1失效
54
IEC1.0
60601-2-54-2009
Medical electrical equipment - part 2-54: particular requirements for the basic safety and essential performance of x-ray equipment for radiography and radioscopy

放射照相及放射透视
2012.8.1失效
57
IEC1.0
60601-2-57-2011
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

用于治疗、诊断、检测及化装/美容的非激光光源