GB/T 4506-1984
Abolished
GB 9706.239-2021
Active
National standards
force_standard
GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Basic Information
Standard Code:
GB 9706.239-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2021-08-10
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:
21 pages
Scope
GB 9706的本部分适用于201.3.208中定义的腹膜透析ME设备的基本安全和基本性能(以下简称PD设备)。本部分适用于预期由医护人员或者在医疗专家监督下使用的PD设备，包括在医院中使用或在家庭环境下使用的由患者操作的PD设备。
若某一章或某一条款明确指出仅适用于ME设备或ME系统，则该章或该条款的标题或正文会说明。如果不是这种情况，与此相关的章或条同时适用于ME设备或ME系统。
除7.2.13和8.4.1外，本部分范围内的ME设备或ME系统的预期生理效应所导致的危险(源)在本部分中没有具体要求。
注： 参见通用标准的4.2。
本部分也适用于为消除或减轻疾病、伤害或残疾所使用的PD设备。
本部分不适用于透析液或透析液管路。
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 9706.226-2021 Medical electrical equipment—Part 2-26:Particular requirements for the basic safety and essential performance of electroencephalographs
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 9706.243-2021 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
YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY/T 0664-2008 Medical device software—Software life cycle processes
YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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
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
YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY 9706.111-2021 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
Adopt standards
IEC 60601-2-39:2018
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced