{"title":"在认证测试中，选择测量医疗器械部件温度的最佳方法","authors":"Anatolii Starunskyi, Oleksandra Kuzmenko, Yevhen Yanchuk","doi":"10.33955/v6(2023)-032","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":139019,"journal":{"name":"Measurements infrastructure","volume":"13 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Choosing the optimal method for measuring the temperature of medical devices parts during certification tests\",\"authors\":\"Anatolii Starunskyi, Oleksandra Kuzmenko, Yevhen Yanchuk\",\"doi\":\"10.33955/v6(2023)-032\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":139019,\"journal\":{\"name\":\"Measurements infrastructure\",\"volume\":\"13 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Measurements infrastructure\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33955/v6(2023)-032\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Measurements infrastructure","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33955/v6(2023)-032","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
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。
Choosing the optimal method for measuring the temperature of medical devices parts during certification tests
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.
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