GB 9706.201-2020 Active National standards force_standard

GB 9706.201-2020 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

GB 9706.201-2020 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

Publish Date: 2020-12-24 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 9706.201-2020
Standard Type: National standards
Standard Status: Active
is_force_gb: yes
CCS Name: Medical radiation equipment
ICS Name: Treatment equipment
Publish Date: 2020-12-24
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: 47 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)。
替换:本部分适用于能量为1 MeV至50 MeV的治疗用电子加速器的基本安全和基本性能,以下简称ME设备。本部分包括型式试验和现场试验,分别适用于电子加速器的制造和某些安装方面:

Development Information

Word Count: 87 Thousand words Pages: 47 pages

Same series standard

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment GB 9706.203-2020 Medical electrical equipment—Part 2-3:Particular requirements for the basic safety and essential performance of short-wave therapy equipment GB 9706.205-2020 Medical electrical equipment—Part 2-5:Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment GB 9706.206-2020 Medical electrical equipment—Part 2-6:Particular requirements for the basic safety and essential performance of microwave therapy equipment GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators GB 9706.217-2020 Medical electrical equipment—Part 2-17:Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment GB 9706.228-2020 Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis GB 9706.237-2020 Medical electrical equipment—Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography GB 9706.245-2020 Medical electrical equipment—Part 2-45:Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices GB 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy GB 9706.260-2020 Medical electrical equipment—Part 2-60:Particular requirements for the basic safety and essential performance of dental equipment GB 9706.263-2020 Medical electrical equipment—Part 2-63:Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Replace the following standards

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB 1002-1996 Single phase plugs and socket-outlets for household and similar purposes Types、basic parameters and dimensions GB/T 1002-2008 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB/T 1002-2021 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 1002-2024 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 1003-1999 Three phases plugs and socket-outlets for household and similar purposes Types,basic parameters and dimensions GB 1003-2008 Three phases plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB/T 1003-2016 Three phases plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 2099.1-1996 Plugs and socket-outlets for household and similar purposes Part 1:General requirements GB/T 2099.1-2008 Plugs and socket-outlets for household and similar purposes—Part 1:General requirements GB/T 2099.1-2021 Plugs and socket-outlets for household and similar purposes—Part 1:General requirements GB/T 2423.2-2008 Environmental testing for electric and electronic products—Part 2:Test methods—Tests B:Dry heat GB/T 2439-2001 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity GB/T 2941-2006 Rubber—General procedures for preparing and conditioning test pieces for physical test methods GB/T 2941-2025 Rubber—General procedures for preparing and conditioning test pieces for physical test methods GB/T 3667.1-2005 AC motor capacitors—Part 1:General—Performance, testing and rating—Safety requirements—Guide for installation and operation GB/T 3667.1-2016 AC motor capacitors—Part 1:General—Performance,testing and rating—Safety requirements—Guide for installation and operation GB/T 3768-1996 Acoustics—Determination of sound power levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane GB/T 3768-2017 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.2-2010 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests GB/T 3785.2-2023 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests GB 3836.1-2000 Electrical apparatus for explosive gas atmospheres—Part 1:General requirements GB 3836.1-2010 Explosive atmospheres—Part 1:Equipment—General requirements GB/T 3836.1-2021 Explosive atmospheres—Part 1:Equipment—General requirements GB 3836.5-2004 Electrical apparatus for explosive gas atmosphere—Part 5:Pressurized enclosures"p" GB/T 3836.5-2017 Explosive atmospheres—Part 5:Equipment protection by pressurized enclosure"p" GB/T 3836.5-2021 Explosive atmospheres—Part 5:Equipment protection by pressurized enclosure "p" GB 3836.6-2004 Electrical apparatus for explosive gas atmospheres—Part 6:Oil-immersion"o" GB/T 3836.6-2017 Explosive atmospheres—Part 6:Equipment protection by liquid immersion“o” GB 3836.7-2004 Electrical apparatus for explosive gas atmospheres—Part 7:Powder filling"q" GB/T 3836.7-2017 Explosive atmospheres—Part 7:Equipment protection by powder filling“q” GB/T 4026-1992 Identification of electric equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system GB/T 4026-2004 Basic and safety principles for man-machine interface, marking and identification-identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system GB/T 4026-2010 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals and conductor terminations GB/T 4026-2019 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals,conductor terminations and conductors GB/T 4026-2025 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals,conductor terminations and conductors GB/T 4074.6-2008 Winding wires—Test methods—Part 6:Thermal properties GB/T 4205-2003 Man-machine interface(MMI)—Actuating principles GB/T 4205-2010 Basic and safety principles for man-machine interface(MMI),marking and identification—Actuating principles GB/T 4207-2003 Method for determining the comparative and the proof tracking indices of solid insulating materials under moist conditions GB/T 4207-2012 Method for the determination of the proof and the comparative tracking indices of solid insulating materials GB/T 4207-2022 Method for the determination of the proof and the comparative tracking indices of solid insulating materials GB 4208-1993 Degrees of protection provided by enclosure (IP code) GB/T 4208-2008 Degrees of protection provided by enclosure(IP code) GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) GB 4706.1-2005 Household and similar electrical appliances—Safety—Part 1:General requirements 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 GB/T 18987-2015 Radiotherapy equipment—Coordinates,movements and scales IEC/TR 60788:2004

Adopt standards

IEC 60601-2-1:2014

Related Standards

Contact Us