应用ISO 17025丰富QoS作为医疗物联网的质量测量

M. Yusro, N. Azlyn, S. I. Purnama
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引用次数: 1

摘要

生物医学工具的质量保证需要关注其测量验证,而不是其治疗人体的功能。研究发现,在医疗物联网(IoMT)上报告的医疗工具中,工具的质量大多仅使用服务质量(QoS)来定义。医疗器械的质量测量还没有成为标准。本文就采用ISO 17025作为质量测量标准开展医疗器械质量评价,特别是验证方法进行了阐述。ISO 17025是使用显著参数测量实验室质量的方法。这些参数包括校准、选择性、灵敏度、精密度(可重复性)、准确度、线性度和工作范围、鲁棒性和坚固性(可重复性)。为了阐明该标准是如何实施的,本文以医疗工具——基于尿素和酸溶液的pH计的肾脏疾病检测仪为例进行了研究。结果表明,尽管QoS是一个非常好的结果,但这种生物医学工具有关键参数,特别是在校准方面。希望本文能对提高医疗器械的质量标准有所参考。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adapting ISO 17025 to Enrich QoS as Quality Measurement on Internet of Medical Things
Biomedical tool quality assurance needs to be concerned regarding its measurement validation worrying its function to treat the human body. It has been found that in reported medical tools on the internet of medical things (IoMT), the quality of the tool is defined mostly only using Quality of Service (QoS). It has not been standard yet that medical tools also must be concerned about their quality measurement. This article imposed to elaborate on developing quality assessment in the medical tool by adapting ISO 17025 as quality measurement, particularly the validation method. ISO 17025 is the method using notable parameters used in the quality of laboratory of measurement. The parameters include calibration, selectivity, sensitivity, precision (repeatability), accuracy, linearity and working range, robustness, and ruggedness (reproducibility). To clarify how this standard is implemented, the medical tool, detector of kidney disorder based on pH meter using urea and acid solution, is employed as a case study. The result said that even though QoS is a very good outcome, this biomedical tool has crucial parameters particularly in calibration. Hopefully, this article could be a reference to enhance the quality standard of medical tools.
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