GB 9706.213-2021
Active
National standards
force_standard
GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation
GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation
Basic Information
Standard Code:
GB 9706.213-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2021-12-01
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:
84 pages
Scope
GB 9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。
本部分适用于医用电气设备和医用电气系统(以下简称ME设备和ME系统)。
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。
本文件适用于需要专业操作者持续参与的、用于管理吸入麻醉的麻醉工作站的基本安全和基本性能。
本文件规定了一个完整的麻醉工作站和下列麻醉工作站组件的专用要求。这些麻醉工作站组件可作为单独设备,也可能和其他相关的麻醉工作站组件组成一个麻醉工作站:
——麻醉气体输送系统;
——麻醉呼吸系统;
——麻醉气体净化系统;
——麻醉气体输送装置;
——麻醉呼吸机;
——监护装置;
——报警系统;
——保护装置。
注1:表AA.1 概述了监护装置、报警系统和保护装置。
考虑到通用标准,完整的麻醉工作站和其独立的组件都作为ME设备或ME系统。
注2:表AA.2给出了本文件的使用环境。
本文件也适用于制造商声称连接到麻醉工作站的附件,如果这些附件的特性影响麻醉工作站的基本安全和基本性能。
如果一章或一条明确指出仅适用于麻醉工作站组件,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麻醉工作站和其独立的组件。
除通用标准7.2.13和8.4.1外,本文件范围内的麻醉工作站和其独立的组件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3:见通用标准4.2。
本文件不适用于附录BB定义的预期使用
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 9706.216-2021 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 9706.239-2021 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
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/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
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/T 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB 3836.4-2000 Electrical apparatus for explosive gas atmospheres—Part 4:Intrinsic safety“i”
GB 3836.4-2010 Explosive atmospheres—Part 4:Equipment protection by intrinsic safety "i"
GB/T 3836.4-2021 Explosive atmospheres—art 4:Equipment protection by intrinsic safety “i”
GB 3836.11-1991 Electrical apparatus for explosive atmospheres-Method of test for ascertainment of maximum experimental safe gap
GB/T 3836.11-2008 Explosive atmospheres—Part 11:Equipment protection by flameproof enclosures “d”—Method of test for ascertainment of maximum experimental safe gap
GB/T 3836.11-2017 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data
GB/T 3836.11-2022 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data
GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary
GB/T 7899-2006 Regulators for welding, cutting and the similar processes
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 15383-2011 Connection types and dimensions for gas cylinder valve outlets
GB 50751-2012 Technical code for medical gases engineering
YY 0339-2002 Suction catheter for use in the respiratory tract
YY 0339-2009 Suction catheter for use in the respiratory tract
YY/T 0339-2019 Suction catheters for use in the respiratory tract
YY/T 0339-2024 Suction catheters for use in the respiratory tract
YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators
YY 0601-2007 Anaesthetic gas monitors
YY 0601-2009 The basic safety and main performance specific requirements for medical electrical equipment respiratory gas monitoring devices
YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements
YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment
YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source
YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source
YY/T 0664-2008 Medical device software—Software life cycle processes
YY/T 0664-2020 Medical device software—Software life cycle processes
YY/T 0755-2009 Anaesthetic vaporizers—Agent-specific filling systems
YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases
YY/T 0801.1-2010 Terminal units for medical gas pipeline systems—Part 1:Terminal units for use with compressed medical gases and vacuum
YY/T 0801.2-2010 Terminal units for medical gas pipeline systems—Part 2:Terminal units for anaesthetic gas scavenging systems
YY/T 0978-2016 Anaesthetic reservoir bags
YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors
ISO 407:2004
ISO 7396-2:2007
Adopt standards
ISO 80601-2-13:2011+AMD1:2015+AMD2:2018
Related Standards
GB 11246-1989
Abolished
YY 0339-2002
Replaced
YY 0339-2002 Suction catheter for use in the respiratory tract
YY/T 0337.1-2002
Active
YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors
YY/T 0337.2-2002
Active
YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube
YY/T 0338.1-2002
Replaced
YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults
YY/T 0338.2-2002
Replaced