Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics
The article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and confo...
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| Format: | Article |
| Language: | Russian |
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Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department
2024-12-01
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| Series: | Здоровье мегаполиса |
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| Online Access: | https://www.city-healthcare.com/jour/article/view/159 |
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| _version_ | 1850064749223477248 |
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| author | V. V. Maslennikov |
| author_facet | V. V. Maslennikov |
| author_sort | V. V. Maslennikov |
| collection | DOAJ |
| description | The article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and conformity assessment of performance characteristics. |
| format | Article |
| id | doaj-art-3f44166104fe42bfba0ae6bb79e270ef |
| institution | DOAJ |
| issn | 2713-2617 |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department |
| record_format | Article |
| series | Здоровье мегаполиса |
| spelling | doaj-art-3f44166104fe42bfba0ae6bb79e270ef2025-08-20T02:49:13ZrusResearch Institute for Healthcare Organization and Medical Management of Moscow Healthcare DepartmentЗдоровье мегаполиса2713-26172024-12-015414216110.47619/2713-2617.zm.2024.v.5i4p1;142-161158Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro DiagnosticsV. V. Maslennikov0Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare DepartmentThe article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and conformity assessment of performance characteristics.https://www.city-healthcare.com/jour/article/view/159in vitro diagnostics medical devicesivdprecisionreproducibilityblank sampleblankanalytical sensitivitymeasuring rangeanalytical interferenceselectivity |
| spellingShingle | V. V. Maslennikov Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics Здоровье мегаполиса in vitro diagnostics medical devices ivd precision reproducibility blank sample blank analytical sensitivity measuring range analytical interference selectivity |
| title | Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics |
| title_full | Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics |
| title_fullStr | Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics |
| title_full_unstemmed | Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics |
| title_short | Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics |
| title_sort | regulatory use of essential performance characteristics of medical devices for in vitro diagnostics |
| topic | in vitro diagnostics medical devices ivd precision reproducibility blank sample blank analytical sensitivity measuring range analytical interference selectivity |
| url | https://www.city-healthcare.com/jour/article/view/159 |
| work_keys_str_mv | AT vvmaslennikov regulatoryuseofessentialperformancecharacteristicsofmedicaldevicesforinvitrodiagnostics |