©2010-2026 宁波自信网络信息技术有限公司 版权所有
客服电话：0574-28810668 投诉电话：18658249818
浙ICP备2021020529号-1 | 浙B2-20240490
关注我们 ：
1、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
2、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—collateralsta
3、ndardelectromagneticcompatibility—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 GB97
4、06.12 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 Medicalelectr
5、icalequipment–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–collat
6、eralstandard: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:Generalrequire
7、mentsforbasicsafetyandessentialperformance–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 Medicalelectricale
8、quipment—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 forbasicsafetyandessentialperforman
9、ce–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: Re
10、quirements 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
11、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
12、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
13、 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
14、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 hi
15、gh-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
16、 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
17、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: part
18、icular 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
19、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
20、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 requirem
21、ents 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
22、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 IE
23、C2.0 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 i
24、ncubators 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 -
25、 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
26、 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
27、 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 GB970
28、6.26 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
29、 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
30、 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 p
31、ressure 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
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
33、 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 pressu
34、re 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 60601-2-36-1
35、997 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 safet
36、y 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
37、 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
38、 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 surgic
39、al 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 elec
40、trical 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 requirement
41、s 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 mammogr
42、aphic 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
43、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
44、 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
45、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
46、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 requirement
47、s 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
©2010-2026 宁波自信网络信息技术有限公司 版权所有
客服电话：0574-28810668 投诉电话：18658249818
浙ICP备2021020529号-1 | 浙B2-20240490
关注我们 ：
