YY 9706.234-2021 Active Industry standards-Medicine

YY 9706.234-2021 Medical electrical equipment—Part 2-34:Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

YY 9706.234-2021 Medical electrical equipment—Part 2-34:Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Publish Date: 2021-09-06 Implement Date: 2024-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 9706.234-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical electronic instruments and equipment
ICS Name: Diagnostic equipment
Publish Date: 2021-09-06
Implement Date: 2024-05-01
Publisher: 国家药品监督管理局
Technical Committee: 全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages: 56 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。
本部分规定了有创血压监护设备(以下简称ME设备)的基本安全和基本性能。
本部分适用于包括相关的传感器,用于循环系统压力的内部测量或监护的有创血压监护设备。
本部分不适用于穿刺导管、穿刺针、鲁尔(Luer)接头、活栓和连接传压隔膜的活栓工作台。
本部分不适用于无创血压监护设备。

Development Information

Drafting Units:

深圳迈瑞生物医疗电子股份有限公司、上海市医疗器械检测所

Drafting Persons:

岑建、陶华、张君、冯广州、贾智娱、韩飞

Word Count: 97 Thousand words Pages: 56 pages

Same series standard

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 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 YY 9706.112-2021 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 YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators YY 9706.221-2021 Medical electrical equipment—Part 2-21:Particular requirements for the basic safety and essential performance of infant radiant warmers YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis YY 9706.235-2021 Medical electrical equipment—Part 2-35:Particular requirements for the basic safety and essential performance of heating devices using blankets,pads or mattresses and intended for heating in medical use YY 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment YY 9706.247-2021 Medical electrical equipment—Part 2-47:Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems YY 9706.250-2021 Medical electrical equipment—Part 2-50:Particular requirements for the basic safety and essential performance of infant phototherapy equipment YY 9706.252-2021 Medical electrical equipment—Part 2-52:Particular requirements for the basic safety and essential performance of medical beds YY 9706.257-2021 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 YY 9706.262-2021 Medical electrical equipment—Part 2-62:Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment YY 9706.269-2021 Medical electrical equipment—Part 2-69:Particular requirements for basic safety and essential performance of oxygen concentrator equipment YY 9706.270-2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment YY 9706.272-2021 Medical electrical equipment—Part 2-72:Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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 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 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 GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment GB 9706.4-2009 Medical electrical equipment—Part 2-2:Particular requirements for the safety of high frequency surgical equipment 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

Adopt standards

IEC 60601-2-34:2011

Related Standards

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