Kumar Rahul, Zafer Afaqul, Dubey P K, Kumar Ashok, Singh Megha, Sharma Nita Dilawar, Jaiswal S K, Prakash Om, Kumar Harish, Gupta V K, Aggarwal Ashutosh, Yadav Sanjay
CSIR-National Physical Laboratory, Dr. K. S. Krishnan Marg, New Delhi 110012, India.
Regional Reference Standard Laboratory, Ahmedabad 382445, India.
Rev Sci Instrum. 2023 Jan 1;94(1):014102. doi: 10.1063/5.0100958.
Blood pressure (BP) measurement is an important physiological parameter for human health monitoring, which plays a significant role in the diagnosis of many incurable diseases. However, due to inaccuracies in the different types of BP measuring devices, the calibration of these BP measuring instruments is a major concern for a medical practitioner. Currently, these devices' calibration, testing, and validation are performed using rigorous methods with complex clinical trials and following the available documentary standards. This article describes the design and development of an indigenous mechanical test bench (MTB) system for the testing and calibration of multiple BP devices, as per International Organization of Legal Metrology (OIML) recommended documents e.g., OIML R 16-1 and OIML R 16-2. The developed system can test and calibrate 20 BP devices, simultaneously. The traceability of the developed MTB is established by performing its calibration against the Air Piston Gauge, a national primary vacuum standard. The estimated expanded measurement uncertainty evaluated is found to be ±0.11 mmHg, which is almost one order better than the measurement uncertainty required for the test and calibration of BP measuring instruments as per standard. The MTB has successfully been used to test and calibrate several BP measuring instruments. The data of one such device is reported herein as an indicator of the performance process. The calibration of these BP measuring instruments was performed in the static mode, and the estimated expanded measurement uncertainty was found to be ±1.25 mmHg. The developed MTB system would prove to be an excellent instrument for calibration laboratories, hospitals, regulatory agencies, and other users to test and calibrate 20 BP measuring devices simultaneously and cost-effectively.
血压（BP）测量是人体健康监测的一项重要生理参数，在许多不治之症的诊断中起着重要作用。然而，由于不同类型血压测量设备存在误差，这些血压测量仪器的校准是医生主要关注的问题。目前，这些设备的校准、测试和验证是采用严格的方法，通过复杂的临床试验并遵循现有的文件标准来进行的。本文介绍了一种国产机械测试台（MTB）系统的设计与开发，该系统可根据国际法制计量组织（OIML）推荐文件（如OIML R 16 - 1和OIML R 16 - 2）对多种血压设备进行测试和校准。所开发的系统可同时测试和校准20台血压设备。通过将其与作为国家一级真空标准的空气活塞压力计进行校准，建立了所开发MTB的可追溯性。评估得出的估计扩展测量不确定度为±0.11 mmHg，这比按照标准对血压测量仪器进行测试和校准所需的测量不确定度几乎好一个数量级。该MTB已成功用于测试和校准多种血压测量仪器。本文报告了其中一台此类设备的数据，作为性能过程的一个指标。这些血压测量仪器的校准是在静态模式下进行的，估计扩展测量不确定度为±1.25 mmHg。所开发的MTB系统将被证明是校准实验室、医院、监管机构及其他用户同时测试和校准20台血压测量设备的一种出色且经济高效的仪器。
