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Evaluating the Performance of Laboratories Testing Sphygmomanometers in Legal Metrology due to Proficiency Testing
MAPAN ( IF 1.0 ) Pub Date : 2020-08-26 , DOI: 10.1007/s12647-020-00388-z
Bruno Amado Rodrigues Filho , Rafael Feldmann Farias , William Escaletti dos Anjos

Proficiency testing is a vital component to ensure quality of tests and calibrations. In particular in legal metrology, the scope of activities claiming for accreditation demands for specific proficiency testing. This study presents the results of the proficiency testing conducted in 2019, in Brazil, for sphygmomanometers, an instrument usually under legal metrology regulation, whose measurements have a direct impact on clinical diagnosis and treatments, according to the International Organization of Legal Metrology Recommendation. The tests comprised initial verification, encompassing general inspection, rapid exhaust valve and maximum permissible error for the cuff indication tests, using the Z-Score as the criteria for the performance of the participants. Five ISO/IEC 17025-accredited laboratories, in Brazil, participated in the proficiency testing. The results show that all five laboratories obtained satisfactory results for the rapid exhaust valve test. One laboratory obtained a questionable result in one measurement for the maximum permissible error test. All laboratories obtained unsatisfactory results for the general inspection. Since the legal metrology requirement comprises all three tests, all laboratories obtained unsatisfactory performance. The results unveiled the necessity for corrective actions to improve the legal control of sphygmomanometers in Brazil. This proficiency testing was also included on the European PT Information System (Eptis) platform.



中文翻译:

评估由于能力验证而在法定计量学中测试血压计的实验室的性能

能力测试是确保测试和校准质量的重要组成部分。特别是在法律计量学中,要求特定能力验证的认证要求的活动范围。根据国际法律计量组织的建议,这项研究显示了2019年在巴西进行的血压计的能力测试的结果,该血压计通常在法律计量法规的监管下,其测量值直接影响临床诊断和治疗。这些测试包括初始验证,包含一般检查,快速排气阀和最大允许误差为袖带指示的测试,使用ž -分数作为参与者表现的标准。巴西的五个ISO / IEC 17025认证实验室参加了能力验证。结果表明,这五个实验室在快速排气门测试中均获得了令人满意的结果。在最大允许误差测试的一项测量中,一个实验室的结果令人怀疑。所有实验室的总检查结果均不令人满意。由于法定计量要求包括所有三个测试,因此所有实验室的性能均不令人满意。结果揭示了采取纠正措施以改善巴西血压计法律控制的必要性。该能力测试也包含在欧洲PT信息系统(Eptis)平台上。

更新日期:2020-08-26
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