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Стан нормативного та методичного забезпечення вимірювань 测量的监管和方法支持状况
Pub Date : 2024-07-18 DOI: 10.33955/v8(2024)-062
І. В. Чижик, І. М. Солоненко
Розглядаються проблемні питання, пов'язані з недостатнім забезпеченням підприємств нормативними документами, що регламентують методики вимірювань. Розглядаються рекомендації Національного органу стандартизації стосовно застосування скасованих міждержавних стандартів, які не замінені національними стандартами України, надаються коментарі. Зазначаються проблеми використання існуючої нормативної бази для вимірювальних підрозділів, викликані несумісністю з діючими нормативно-правовими актами та нормативними документами. Пропонуються шляхи вирішення наведених проблем для підприємств, що виконують вимірювання та претендують на певне визнання вимірювальних можливостей.
文章探讨了与企业未充分获得有关测量方法的规范性文件有关的问题。文章考虑了国家标准化机构关于应用未被乌克兰国家标准取代的已取消国际标准的建议,并提供了评论意见。指出了因与现行法律法规和规范性文件不一致而导致的现有计量单位规范框架的使用问题。提出了解决这些问题的方法,供进行测量并要求承认一定测量能力的企业参考。
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引用次数: 0
The National Calibration Service of Ukraine as an integral part of the National Quality Infrastructure
Pub Date : 2024-07-15 DOI: 10.33955/v7(2024)-059
Sergii Tsiporenko, O. Samoilenko, Yrii Kuzmenko
Many serious system nonconformities described in this article have been found during the accreditation of some Ukrainian calibration laboratories. These nonconformities raise concerns about the competence and ability of such laboratories to perform calibration in the published scopes in a proper manner. Moreover, it also discredits the accreditation system in Ukraine and threatens its international recognition. To avoid this in the future, it is proposed to establish the National Calibration Service of Ukraine. The main tasks of the service will be exchanging experience and transferring knowledge in calibration activity, implementing modern calibration methods, organizing interlaboratory comparisons, and proficiency testing for various categories of measuring instruments and reference materials, etc. This will provide a solid foundation for a properly functioning metrology system and the national economy with reliable, qualified, and internationally recognized calibrations.
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引用次数: 0
Legislation of Ukraine requirements on verification of medical devices with measuring function 乌克兰关于具有测量功能的医疗器械的核查要求的立法
Pub Date : 2024-07-06 DOI: 10.33955/v8(2024)-054
Bagrieiev Maksym, Moroz Viktoriia, Lovkin Maksym, Llc «Cratia, Україна Medtechnika»
This article addresses the necessity of verifying medical devices with measuring functionality, highlights key legislative changes, and underscores the requirements for verification at the time of deployment/usage and throughout the operational lifespan of medical devices involving measuring functions. Legislative changes have led to a lack of awareness among healthcare facilities using medical devices with measuring functions regarding the regulatory requirements, ensuring measurement accuracy for proper diagnosis, diagnostics, monitoring, and treatment. Therefore, familiarity with legislation and adherence to established requirements enable the implementation of preventive measures to safeguard public health and safety while minimizing risks associated with the use of medical devices. Thus, this article is crucial for enhancing awareness regarding the verification requirements for medical devices with measurement functions and for the proper fulfillment of responsibilities by facilities employing such medical devices with measuring functions.
本文阐述了对具有测量功能的医疗设备进行验证的必要性,重点介绍了主要的立法变化,并强调了在涉及测量功能的医疗设备部署/使用时和整个运行寿命期间进行验证的要求。立法变化导致使用具有测量功能的医疗设备的医疗机构缺乏对监管要求的认识,无法确保正确诊断、诊断、监测和治疗所需的测量准确性。因此,熟悉法规并遵守既定要求,才能实施预防措施,保障公众健康和安全,同时将与使用医疗器械相关的风险降至最低。因此,本文对于提高人们对具有测量功能的医疗器械的验证要求的认识,以及使用此类具有测量功能的医疗器械的机构正确履行职责至关重要。
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引用次数: 0
Audit of the effectiveness of a quality management system or its processes? 对质量管理体系或其流程的有效性进行审计?
Pub Date : 2024-07-06 DOI: 10.33955/v8(2024)-050
Ludmyla Aksenova
Guided by the provisions of DSTU ISO 9000, the article defines the objects of internal audit (hereinafter audit) and proves the choice of these objects for estimation of their effectiveness. It is determined that the audit of a quality management system (QMS) effectiveness is performed to establish its generalized evaluation, which is used by top management to make strategic decisions, and the audit of the QMS processes effectiveness is to establish evaluations for each process, which are used by middle managers to make operational decisions. The difference between corrective actions and actions to improve the effectiveness of the audited objects is shown. It is established that to improve the effectiveness of the QMS, strategic (long-term) quality objectives are developed, and to improve its processes, operational quality objectives are developed. Practical examples are provided to illustrate the conclusions. The obtained results of the study are the basis for creating a procedure for evaluating the effectiveness of the QMS and its processes during the audit.
文章以 DSTU ISO 9000 的规定为指导,定义了内部审核(以下简称审核)的对象,并证明了选择这些对象来评估其有效性的方法。据确定,对质量管理体系(QMS)有效性的审核是为了确定其总体评价,供高层管理人员做出战略决策时使用;而对质量管理体系过程有效性的审核是为了确定每个过程的评价,供中层管理人员做出运营决策时使用。纠正行动和提高审核对象有效性的行动之间存在差异。为了提高质量管理体系的有效性,需要制定战略(长期)质量目标,而为了改进其流程,需要制定运营质量目标。为说明结论,提供了实际案例。研究结果是制定审计期间质量管理体系及其流程有效性评估程序的基础。
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引用次数: 0
Determining the parameters of the oil film on the sea surface using remote sensing data 利用遥感数据确定海面油膜参数
Pub Date : 2023-08-30 DOI: 10.33955/v6(2023)-048
Mykola Dominikov, Myroslav T. Strynadko, Bogdan Tymochko
Oil spill accidents have gradually increased due to the continuous development of marine transportation and petroleum processing industries. Monitoring and managing marine oil spills present important economic, social, and practical implications in preventing offshore oil pollution and maintaining ecological balance. Remote sensing technologies play an increasingly important role in accurate detection and monitoring of oil spill slicks, assisting scientists in forecasting their trajectories, developing clean-up plans, taking timely and urgent actions, and applying effective treatments to contain and alleviate adverse effects. A method is proposed for remote sensing of an oil film on the sea surface based on irradiation with frequency-modulated laser radiation with a linear dependence of frequency on time. According to the spectrum of temporal changes in the intensity of the radiation reflected by the surface, the average thickness of the oil film, the distribution function of the oil film thickness, and the volume of spilled oil are determined. Taking into account the possibility of registering beat frequencies from fractions of a hertz to megahertz with modern instruments, we can talk about the possibility of measuring oil thicknesses from hundreds of angstroms to tens of meters using the proposed method of remote sensing. The method also makes it possible to additionally determine the thickness distribution function and the volume of spilled oil. The method proposed in this study has obvious advantages in terms of small sample size and processing efficiency and has great application potential in the field of maritime supervision.
随着海洋运输和石油加工业的不断发展,溢油事故逐渐增多。监测和管理海洋溢油对防止近海石油污染和维护生态平衡具有重要的经济、社会和现实意义。 遥感技术在准确探测和监测溢油浮渣、协助科学家预测溢油轨迹、制定清理计划、及时采取紧急行动以及应用有效的处理方法来控制和减轻不利影响等方面发挥着越来越重要的作用。 本文提出了一种基于频率与时间线性相关的频率调制激光辐射的海面油膜遥感方法。根据海面反射的辐射强度的时间变化谱,可以确定油膜的平均厚度、油膜厚度的分布函数以及溢出油的体积。 考虑到现代仪器可以记录从几分之一赫兹到几百万赫兹的跳动频率,我们可以说,使用建议的遥感方法可以测量从几百埃到几十米的油膜厚度。该方法还能额外确定厚度分布函数和泄漏油量。 本研究提出的方法在样本量小和处理效率方面具有明显优势,在海事监管领域具有巨大的应用潜力。
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引用次数: 0
Choosing the optimal method for measuring the temperature of medical devices parts during certification tests 在认证测试中,选择测量医疗器械部件温度的最佳方法
Pub Date : 2023-07-26 DOI: 10.33955/v6(2023)-032
Anatolii Starunskyi, Oleksandra Kuzmenko, Yevhen Yanchuk
The issues of choosing the optimal method for measuring the temperature of medical devices parts during their certification in accordance with the requirements of the general standard DSTU EN 60601-1:2019 are considered. Such measurements should be provided both during the normal operation of medical devices and for conditions of a single violation. It is proposed to carry out a preliminary temperature assessment of the medical device’s internal components using a thermal imager, which makes it possible to determine the components of the devices with a higher temperature. Furthermore, only then carry out an accurate temperature measurement of certain product components using a set of calibrated thermocouples of the TXA (K) type connected to a modern data acquisition and switching system. This greatly simplifies the process of measuring the temperature of medical devices parts and reduces its complexity. Practical examples of such tests are given.
根据通用标准DSTU EN 60601-1:2019的要求,考虑在认证期间选择测量医疗器械部件温度的最佳方法的问题。这种测量应在医疗设备正常运行期间和在单一违规情况下进行。建议使用热成像仪对医疗器械内部组件进行初步温度评估,从而可以确定具有较高温度的器械组件。此外,只有使用一组连接到现代数据采集和开关系统的TXA (K)型校准热电偶,才能对某些产品组件进行精确的温度测量。这大大简化了医疗器械部件温度测量的过程,降低了测量的复杂性。给出了这种测试的实例。
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引用次数: 0
Virtual practicum for research of mathematical algorithms using Digital Signal Processing 数字信号处理数学算法研究的虚拟实习
Pub Date : 2023-07-26 DOI: 10.33955/v6(2023)-035
M. Morozova
The article describes an approach to the organisation of a virtual laboratory practicum for research in the Digital Signal Processing (DSP) field. Such an approach may be useful in implementing a part of the educational process in a distant mode. The laboratory setting simulation method based on LabVIEW software was used to solve the research tasks. It is advisable to create and implement this integrated educational solution — virtual laboratory practicum — in the educational process of universities that train engineers. It will allow students to have laboratory and practical training to improve specialists’ qualifications and carry out control activities. Using such an environment will allow extension course students, teachers, and trainees to perform assigned tasks without time limit, both in virtual form and in the form of training before working with real equipment. It will also allow students to carry out additional research on their own in the Digital Signal Processing sphere, which will increase their interest.
本文介绍了一种组织数字信号处理(DSP)领域研究的虚拟实验室实习的方法。这种方法在远程模式下实施教育过程的一部分可能是有用的。采用基于LabVIEW软件的实验室设置仿真方法解决研究任务。在培养工程师的高校的教育过程中,创建和实施虚拟实验室实习这一综合教育方案是可取的。它将允许学生进行实验室和实践培训,以提高专家的资格和开展控制活动。使用这样的环境将允许扩展课程的学生、教师和学员在使用实际设备之前以虚拟形式和培训形式无时间限制地执行指定的任务。它还将允许学生在数字信号处理领域进行自己的额外研究,这将增加他们的兴趣。
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引用次数: 0
Стан впровадження систем керування вимірюваннями на підприємствах і в організаціях України
Pub Date : 2023-07-26 DOI: 10.33955/v6(2023)-036
І. В. Чижик, І. М. Солоненко
Надається порівняльний аналіз стану метрологічної діяльності суб’єктів господарювання до та після набрання чинності Законом [1] в частині виконання вимірювань як у сфері, так і поза сферою законодавчо регульованої метрології. Проводиться аналіз деяких нормативно-правових актів, що регламентують вимоги до підприємств та порядок їх уповноваження (атестації) на проведення певних вимірювань, не пов’язаних з оцінкою відповідності продукції, процесів та послуг. Зазначаються проблемні питання впровадження суб’єктами господарювання нормативних документів, які регламентують вимоги до систем керування вимірюваннями. Зазначаються основні проблеми, пов’язані з документуванням суб'єктами господарювання методик системи керування вимірюваннями. Пропонуються шляхи вирішення наведених проблем для суб’єктів господарювання, які вважають за доцільне проведення оцінювання та визнання вимірювальних можливостей на добровільних засадах.
文章对《计量法》[1]生效前后企业实体的计量活动状况进行了比较分析,包括受法律监管的计量领域内外的计量活动。作者分析了一些规范企业要求及其授权(认证)程序的法案,以进行某些与产品、工艺和服务合格评定无关的测量。文中指出了企业在执行有关测量管理系统要求的规范性文件时遇到的问题。指出了与企业实体记录测量管理体系方法有关的主要问题。作者为那些认为在自愿基础上评估和认可测量能力是权宜之计的企业实体提出了解决这些问题的方法。
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引用次数: 0
Structural renovation of the Secondary standard of the electric power unit for the industrial frequency range 工业频率范围电力机组二级标准结构改造
Pub Date : 2023-05-05 DOI: 10.33955/v5(2023)-029
Serhii Shevkun, Maryna Dobroliubova, Oleksii Statsenko
The article reveals ways for structural renovation of the composition of the Secondary standard of the electrical power unit for the industrial frequency range with the aim of restoring the technical resource of its constituent parts, improving metrological characteristics in terms of increasing output power, as well as increasing productivity and reducing the cost of work due to their automation. Based on the results of the metrological characteristics’ analysis of electrical energy and power measuring equipment modern nomenclature and the existing standard base, it is proposed to make a structural renovation of the standard by including additional equipment to its composition, namely: the precision three-phase standard electricity meter compatible with the high-precision three-phase power source. The structural scheme of the renovation standard has been developed. The renovation of the standard allows turning the standard into a single hardware and software complex that provides calibration and testing of wide nomenclature of electric power and electric energy meters in the full range of values in high-performance automated mode.
本文揭示了工业频率范围内电力机组二次标组成结构改造的途径,目的是恢复其组成部件的技术资源,在增加输出功率方面改善计量特性,并由于其自动化而提高生产率和降低工作成本。根据电能电力计量设备现代命名法计量特性分析结果和现有标准基础,提出对标准进行结构改造,在其组成中增加配套设备,即:与高精度三相电源配套的精密三相标准电能表。制定了改造标准的结构方案。该标准的更新允许将标准变成一个单一的硬件和软件综合体,在高性能自动化模式下,为电力和电能表的全范围值提供校准和测试。
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引用次数: 0
Automation of evaluation of the interlaboratory comparisons results by means of software 利用软件实现实验室间比较结果的自动化评价
Pub Date : 2023-05-05 DOI: 10.33955/v5(2023)-039
O. Velychko, S. Kursin, V. Haman
The number of interlaboratory comparisons of measurement results increase, and the number of their participants requires providers to automate data processing procedures. The article is devoted to developing software for the calculation automation and display of interlaboratory comparisons results. The article analyzes the existing software and identifies its main shortcomings. Peculiarities of the application of En, z and ξ criteria are considered. Features of using the Python programming language for calculations and data display are described. Using the example of conducted interlaboratory comparisons, the possibilities of the developed software for automating calculations and data analysis, and displaying results, are demonstrated.
实验室间测量结果比较的数量增加,参与者的数量要求供应商自动化数据处理程序。本文致力于开发用于计算自动化和实验室间比较结果显示的软件。本文对现有软件进行了分析,指出了其主要不足。考虑了En、z和ξ准则应用的特殊性。描述了使用Python编程语言进行计算和数据显示的特点。通过进行实验室间比较的例子,演示了开发的软件在自动计算和数据分析以及显示结果方面的可能性。
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引用次数: 0
期刊
Measurements infrastructure
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