GB 11243-2000
Replaced
GB 9706.226-2021
Active
National standards
force_standard
GB 9706.226-2021 Medical electrical equipment—Part 2-26:Particular requirements for the basic safety and essential performance of electroencephalographs
GB 9706.226-2021 Medical electrical equipment—Part 2-26:Particular requirements for the basic safety and essential performance of electroencephalographs
Basic Information
Standard Code:
GB 9706.226-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Medical electronic instruments and equipment
ICS Name:
Diagnostic equipment
Publish Date:
2021-10-11
Implement Date:
2023-05-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
27 pages
Scope
本文件规定了在201.3.63中定义的脑电图机（以下简称ME设备）的基本安全和基本性能。
本文件适用于在临床环境（例如，医院，医生办公室等）中使用的ME设备。
本文件不适用于在脑电图学中使用的其他设备，例如：
——声光刺激器；
——遥测脑电图仪；
——脑电数据的存储和重现设备；
——用于在电休克疗法中监护的专用ME设备；
——动态脑电图记录器。
如果一章或一条明确指出仅适用于ME设备或ME系统，标题和章或条的正文会说明。如果不是这种情况，与此相关的章或条同时适用于ME设备和ME系统。
除通用标准的7.2.13与8.4.1外，本文件范围内的ME设备或ME系统的预期生理效应所导致的危险在本文件中没有具体要求。
注：参见通用标准的4.2。
Development Information
Same series standard
GB 9706.202-2021 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
GB 9706.208-2021 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
GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation
GB 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
GB 9706.219-2021 Medical electrical equipment—Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators
GB 9706.224-2021 Medical electrical equipment—Part 2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers
GB 9706.225-2021 Medical electrical equipment—Part 2-25:Particular requirements for the basic safety and essential performance of electrocardiographs
GB 9706.227-2021 Medical electrical equipment—Part 2-27:Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
GB 9706.229-2021 Medical electrical equipment—Part 2-29:Particular requirements for the basic safety and essential performance of radiotherapy simulators
GB 9706.236-2021 Medical electrical equipment—Part 2-36:Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
GB 9706.243-2021 Medical electrical equipment—Part 2-43:Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
GB 9706.265-2021 Medical electrical equipment—Part 2-65:Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Replace the following standards
Referenced Standards
ISO 2882
ISO 3864-1:2002
ISO 7000:2004
ISO 7010:2011
ISO 9614-1
ISO 80000-1:2009
IEC 60601-1-6
IEC 60730-1:2010
IEC 60851-3:2009
IEC 60851-5:2008
GB/T 4208-2017 Degrees of protection provided by enclosure(IP code)
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
Adopt standards
IEC 60601-2-26:2012
Related Standards
GB 1588-2001
Replaced
GB 1588-2001 Clinical thermometer
YY 0109-2003
Replaced
YY 0109-2003 Medical ultrasonic nebulizer
YY 0455-2003
Replaced
YY 0455-2003 Medical electrical equipment—Part 2:Particular requirments for the safety of infant radiant warmers
YY/T 1036-2004
Active
YY/T 1036-2004 Impression tonometers
GB/T 19665-2005
Replaced