浮标式氧吸入器氧气压力表检定分析数据
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浮标式氧气吸入器是广泛应用风险较高的医疗器械。检定分析得出的结果来判断浮标式氧吸入器氧气压力表是否符合氧气压力表检定要求,有助于判断市场上浮标式氧气吸入器的的整体质量,为政府监管、医疗单位购买提供参考和技术支撑。1数据采集:名称、型号、送检单位、编号、最大量程范围、零位误差、指针偏转平稳性,按照浮标式氧气吸入器计量检定规程要求测得的3个检定点升压被检氧气压力表示值、降压被检氧气压力表示值、升压轻敲位移示值变动量、降压轻敲位移示值变动量、回程误差等;2数据处理:(1)检定点示值误差,为检定点升压被检氧气压力表示值与检定点标准氧气压力表示值误差、检定点降压被检氧气压力表示值与检定点标准氧气压力表示值误差中大的误差值;(2)检定点轻敲位移,为检定点升压、降压轻敲位移示值变动量大的值;(3)是否符合氧气压力表检定要求,规程要求零位误差为符合、指针偏转平稳性为符合要求、3个检定点示值误差、回程误差、轻敲位移分别为±最大量程范围*2.5%、最大量程范围*2.5%、最大量程范围*2.5%/2,当零位误差、指针偏转平稳性、3个检定点示值误差、回程误差、轻敲位移都符合要求的为符合,反之为不符合;3其他说明:检定点标准氧气压力表示值为与被检定氧压力表相同检定点另一精密压力表的示值。
Buoy-type oxygen inhalers are high-risk medical devices with wide applications. The results of verification analysis used to determine whether the oxygen pressure gauges of buoy-type oxygen inhalers meet the verification requirements for oxygen pressure gauges help evaluate the overall quality of buoy-type oxygen inhalers on the market, providing reference and technical support for government supervision and medical institution procurement. 1. Data Collection: Collected data includes name, model, inspection submitting unit, serial number, maximum measuring range, zero error, and stability of pointer deflection. Measured in accordance with the metrological verification regulation for buoy-type oxygen inhalers, the data also covers: measured indication values of the oxygen pressure gauge under test at 3 check points during pressure rise and pressure drop, variation of tapping displacement indication during pressure rise, variation of tapping displacement indication during pressure drop, and backlash error, etc. 2. Data Processing: (1) Check point indication error: Take the larger error value between the error of the measured indication value of the oxygen pressure gauge under test at the check point during pressure rise relative to the standard oxygen pressure indication value at the same check point, and the error of the measured indication value of the oxygen pressure gauge under test during pressure drop relative to the standard oxygen pressure indication value at the same check point. (2) Check point tapping displacement: Take the larger variation value of the tapping displacement indication at the check point during pressure rise and pressure drop. (3) Compliance judgment for oxygen pressure gauge verification requirements: The regulation specifies that the zero error and stability of pointer deflection must both meet the requirements, and the three check point indication errors, backlash error, and tapping displacement must meet ±2.5% of the maximum measuring range, 2.5% of the maximum measuring range, and 2.5%/2 of the maximum measuring range respectively. A buoy-type oxygen inhaler is deemed compliant only if all the above items (zero error, stability of pointer deflection, three check point indication errors, backlash error, and tapping displacement) meet the requirements; otherwise, it is deemed non-compliant. 3. Other Notes: The standard oxygen pressure indication value at the check point refers to the indication value of another precision pressure gauge at the same check point as the oxygen pressure gauge under test.




