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
Basic Information
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.