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
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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
Pages: 56 pages

Scope

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or article explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or article will indicate this. If this is not the case, the relevant chapter or article applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This part specifies the basic safety and basic performance of invasive blood pressure monitoring devices (hereinafter referred to as ME devices).
This part applies to invasive blood pressure monitoring devices, including related sensors, used for internal measurement or monitoring of the pressure of the circulatory system.
This part does not apply to puncture catheters, puncture needles, Luer connectors, live valves, and live valve worktables used to connect pressure-transmitting diaphragms.
This part does not apply to non-invasive blood pressure monitoring devices.

Development Information

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

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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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