Summary Of China Standards Of 9706 Series Effective Since May 1, 2023
2023-07-19
China standards of 9706 series have been effective since May 1, 2023. The summary is shown as below. It will greatly impact the type testing, registration and modification in China. Please reach out to BradyKnows elite team to solve your questions on type testing in China via info@bradyknowsmedical.com.
序号
Serial No.
标准领域
Standard
field
标准编号
Standard number
标准名称
Standard name
实施日期
Effective date
替代标准
Standard replaced
1
通用
General
GB
9706.1-2020
(IEC
60601-1:2012, MOD)
医用电气设备第1部分：基本安全和基本性能的通用要求
Medical
electrical equipment Part 1: General requirements for basic safety and essential performance
5/1/2023
GB
9706.1-2007 GB 9706.15-2008
2
GB
9706.103-2020
(IEC
60601-1-3: 2013, MOD)
医用电气设备第1-3部分：基本安全和基本性能的通用要求并列标准：诊断X射线设备的辐射防护
Medical
electrical equipment Part 1-3: General requirements for basic safety and essential
performance
Collateral
standard: radiation protection in diagnostic X-ray equipment
5/1/2023
GB
9706.12-1997
3
YY
9706.102-2021
(IEC
60601-1-2: 2007, MOD)
医用电气设备第1-2部分：基本安全和基本性能的通用要求并列标准：电磁兼容要求和试验
Medical
electrical equipment Part 1-2: General requirements for basic safety and essential
performance
Collateral
standard: Electromagnetic compatibility – Requirements and testing
5/1/2023
YY
0505-2012
4
YY
9706.108-2021
(IEC
60601-1-8: 2006+A1: 2012, MOD)
医用电气设备第1-8部分：基本安全和基本性能的通用要求
并列标准：通用要求，医用电气设备和医用电气系统中报警系统的测试和指南
Medical
electrical equipment Part 1-8: General requirements for basic safety and essential
performance
Collateral
standard: General requirements, testing and guidance for alarm systems in medical equipment
and medical electrical systems
Medical
electrical equipment Part 1-12: General requirements for basic safety and essential
performance
Collateral
standard: Requirements for Medical electrical equipment and medical electrical systems
intended for use in the emergency medical services environment
5/1/2023
/
7
YY/T
9706.106-2021
(IEC
60601-1-6: 2013, MOD)
医用电气设备第1-6部分：基本安全和基本性能的通用要求 并列标准：可用性
Medical
electrical equipment Part 1-6: General requirements for basic safety and essential
performance
Collateral
standard: Usability
5/1/2023
/
8
YY/T
9706.110-2021
(IEC
60601-1-10: 2007+A1: 2013, MOD)
医用电气设备第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求
Medical
electrical equipment Part 1-10: General requirements for basic safety and essential
performance
Collateral
standard: Requirements for the development of physiological closed-loop controllers
5/1/2023
/
9
专用
Particular
GB
9706.260-2020
(IEC
80601-2-60: 2012, MOD)
医用电气设备第2-60部分：牙科设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-60: Particular requirements for the
basic safety and essential performance of dental equipment
5/1/2023
/
10
GB
9706.228-2020
(IEC
60601-2-28: 2017, MOD)
医用电气设备第2-28部分：医用诊断X射线管组件的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-28: Particular requirements for the
basic safety and essential performance of X-ray tube assemblies for medical diagnosis
5/1/2023
GB
9706.11-1997
11
GB
9706.254-2020
(IEC
60601-2-54: 2018, MOD)
医用电气设备第2-54部分：X射线摄影和透视设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-54: Particular requirements for the
basic safety and essential performance of X-ray equipment for radiography and radioscopy
5/1/2023
/
12
GB
9706.243-2021
(IEC
60601-2-43: 2017, MOD)
医用电气设备第2-43部分：介入操作X射线设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-43: Particular requirements for the
basic safety and essential performance of X-ray equipment for Interventional procedures
5/1/2023
GB
9706.23-2005
13
GB
9706.245-2020
(IEC
60601-2-45: 2015, MOD)
医用电气设备第2-45部分；乳腺X射线摄影设备和乳腺摄影立体定位装置的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-45: Particular requirements for the
basic safety and essential performance of mammographie
stereotactic devices
5/1/2023
GB
9706.24-2005
14
GB
9706.263-2020
(IEC
60601-2-63: 2017, MOD)
医用电气设备第2-63部分：口外成像牙科X射线机基本安全和基本性能专用要求
Medical
electrical equipment Part 2-63: Particular requirements for the
basic safety and essential performance of dental extra-oral X-ray equipment
5/1/2023
/
15
GB
9706.265-2021
(IEC
60601-2-65: 2017, MOD)
医用电气设备第2-65部分：口内成像牙科X射线机的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-65: Particular requirements for the
basic safety and essential performance of dental intra-oral X-ray equipment
5/1/2023
/
16
GB
9706.244-2020
(IEC
60601-2-44: 2016, MOD)
医用电气设备第2-44部分：X射线计算机体层摄影设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-44: Particular requirements for the
basic safety and essential performance of X-ray equipment for computed tomography
5/1/2023
GB
9706.18-2006
17
GB
9706.237-2020
(IEC
60601-2-37: 2015, MOD)
医用电气设备第2-37部分：超声诊断和监护设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
5/1/2023
GB
9706.9-2008
18
GB
9706.205-2020
(IEC
60601-2-5: 2009, MOD)
医用电气设备第2-5部分：超声理疗设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-5: Particular requirements for the
basic safety and essential performance of ultrasonic physiotherapy equipment
5/1/2023
GB
9706.7-2008
19
YY
9706.262-2021
(IEC
60601-2-62: 2013, MOD)
医用电气设备第2-62部分：高强度超声治疗(HITU)设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-62: Particular requirements for the
basic safety and essential performance of high intensity therapeutic ultrasound (HITU)
equipment
5/1/2023
/
20
GB
9706.225-2021
(IEC
60601-2-25: 2011, MOD)
医用电气设备第2-25部分：心电图机的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-25: Particular requirements for the
basic safety and essential performance of electrocardiographs
5/1/2023
GB
10793-2000
21
GB
9706.226-2021
(IEC
60601-2-26: 2012, MOD)
医用电气设备第2-26部分：脑电图机的基本安全和基本性能专用要求
Medical
electrical equipment part 2-26: Particular requirements for the
basic safety and essential performance of electroencephalographs
5/1/2023
GB
9706.26-2005
22
YY
9706.240-2021
(IEC
60601-2-40: 2016, MOD)
医用电气设备第2-40部分：肌电及诱发反应设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-40: Particular requirements for the
basic safety and essential performance of electromyographs and evoked response equipment
5/1/2023
YY
0896-2013
23
YY
9706.233-2021
(IEC
60601-2-33: 2015, MOD)
医用电气设备第2-33部分：医疗诊断用磁共振设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-33: Particular requirements for the
basic safety and essential performance of magnetic resonance equipment for medical
diagnostics
5/1/2023
YY
0319-2008
24
GB
9706.227-2021
(IEC
60601-2-27: 2011, MOD)
医用电气设备第2-27部分：心电监护设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-27: Particular requirements for the
basic safety and essential performance of electrocardiographic monitoring equipment
5/1/2023
GB
9706.25-2005
25
GB
9706.202-2021
(IEC
60601-2-2: 2017, MOD)
医用电气设备第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
5/1/2023
GB
9706.4-2009
26
GB
9706.224-2021
(IEC
60601-2-24: 2012, MOD)
医用电气设备第2-24部分：输液泵和输液控制器的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-24: Particular requirements for the
basic safety and essential performance of infusion pumps and controllers
5/1/2023
GB
9706.27-2005
27
GB
9706.236-2021
(IEC
60601-2-36: 2014, MOD)
医用电气设备第2-36部分：体外引发碎石设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-36: Particular requirements for the
basic safety and essential performance of equipment for extracorporeally induced lithotripsy
5/1/2023
GB
9706.22-2003
28
GB
9706.219-2021
(IEC
60601-2-19: 2016, MOD)
医用电气设备第2-19部分：婴儿培养箱的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-19: Particular requirements for the
basic safety and essential performance of infant Incubators
5/1/2023
GB
11243-2008
29
YY
9706.220-2021
(IEC
60601-2-20: 2009+AMDI: 2016, MOD)
医用电气设备第2-20部分：婴儿转运培养箱的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-20: Particular requirements for the
basic safety and essential performance of infant transport incubators
5/1/2023
YY
0827-2011
30
GB
9706.201-2020
(IEC
60601-2-1: 2014, MOD)
医用电气设备第2-1部分：能量为1MeV至50MeV电子加速器基本安全和基本性能专用要求
Medical
electrical equipment Part 2-1: Particular requirements for the
basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
5/1/2023
GB
9706.5-2008
31
GB
9706.208-2021
(IEC
60601-2-8: 2015, MOD)
医用电气设备第2-8部分：能量为10kV至1MV治疗X射线设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-8: Particular requirements for the
basic safety and essential performance of therapeutic X-ray equipment operating in the range
10kV to 1MV
5/1/2023
GB
9706.10-1997
32
GB
9706.211-2020
(IEC
60601-2-11: 2013, MOD)
医用电气设备第2-11部分：y射束治疗设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-11: Particular requirements for the
basic safety and essential performance of gamma beam therapy equipment
5/1/2023
GB
9706.17-2009
33
GB
9706.217-2020
(IEC
60601-2-17: 2013, MOD)
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的 基本安全和基本性能专用要求
Medical
electrical equipment Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy afterloading equipment
5/1/2023
GB
9706.13-2008
34
GB
9706.229-2021
(IEC
60601-2-29: 2008, MOD)
医用电气设备第2-29部分：放射治疗模拟机的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-29: Particular requirements for the
basic safety and essential performance of radiotherapy simulators
5/1/2023
GB
9706.16-2015
35
GB 9706.216-2021
(IEC 60601-2-16: 2018, MOD)
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 过设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-16: Particular requirements for the
basic safety and essential performance of heamodialysis, haemodiafiltration and haemodiafiltration equipment
5/1/2023
GB
9706.2-2003
36
GB
9706.239-2021
(IEC
60601-2-39: 2018, MOD)
医用电气设备第2-39部分：腹膜透析设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-39: Particular requirements for the
basic safety and essential performance of peritoneal dialysis equipment
5/1/2023
GB
9706.39-2008
37
GB
9706.213-2021
(ISO
80601-2-13: 2011, MOD)
医用电气设备第2-13部分：麻醉工作站的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-13: Particular requirements for the
basic safety and essential performance of an anaesthetic
workstations
5/1/2023
GB
9706.29-2006
38
GB
9706.212-2020
(ISO
80601-2-12: 2011, MOD)
医用电气设备第2-12部分：重症护理呼吸机的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-12: Particular requirements for the
basic safety and essential performance of critical care ventilators
5/1/2023
GB
9706.28-2006
39
YY
9706.269-2021
(ISO
80601-2-69: 2014, MOD)
医用电气设备第2-69部分：氧气浓缩器的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-69: Particular requirements for the
basic safety and essential performance of oxygen concentrator equipment
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
5/1/2023
/
41
GB
9706.218-2021
(IEC
60601-2-18: 2009, MOD)
医用电气设备第2-18部分：内窥镜设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-18: Particular requirements for the
basic safety and essential performance of endoscopic equipment
5/1/2023
GB
9706.19-2000
42
YY
9706.241-2020
(IEC
60601-2-41: 2013, MOD)
医用电气设备第2-41部分：手术无影灯和诊断用照明灯的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-41: Particular requirements for the
basic safety and essential performance of surgical luminaires
And
luminaires for diagnosis
5/1/2023
YY
0627-2008
43
GB
9706.203-2020
(IEC
60601-2-3: 2016, MOD)
医用电气设备第2-3部分：短波治疗设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-3: Particular requirements for the
basic safety and essential performance of short-wave therapy equipment
5/1/2023
/
44
GB
9706.206-2020
(IEC
60601-2-6: 2016, MOD)
医用电气设备第2-6部分：微波治疗设备的基本安全和基本性能专用要求
Medical
electrical equipment Part 2-6: Particular requirements for the
basic safety and essential performance of microwave therapy equipment
5/1/2023
GB
9706.6-2007
45
YY
9706.210-2021
(IEC
60601-2-10: 2012+AMDI: 2016 CSV, MOD)
医用电气设备第2-10部分：神经和肌肉刺激器的 基本安全和基本性能专用要求
Medical
electrical equipment Part 2-10: Particular requirements for the
basic safety and essential performance of nerve and muscle stimulators
5/1/2023
YY
0607-2007
46
YY
9706.235-2021
(IEC
80601-2-35: 2009+AMDI: 2016 CSV, MOD)
医用电气设备第2-35部分：医用毯、垫或床垫式加热设备的 基本安全和基本性能专用要求
Medical
electrical equipment Part 2-35: Particular requirements for the
basic safety and essential performance of heating devices using blankets, pads or mattress
and intended for heating in medical use
5/1/2023
YY
0834-2011
47
YY
9706.250-2021
(IEC
60601-2-50: 2009+A1: 2016, MOD)
医用电气设备第2-50部分：婴儿光治疗设备的 基本安全和基本性能专用要求
Medical
electrical equipment Part 2-50: Particular requirements for the
basic safety and essential performance of infant phototherapy equipment
