DIN EN ISO 12487:2025-01
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024 / Note: Date of issue 2024-12-06*Intended as replacement for DIN EN ISO 80601-2-56 (2020-08, t).
| Fecha edición: |
2025-01-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. This document is not intended for clinical thermometers measuring the body temperature in direct measurement mode. NOTE 1 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. NOTE 2 For clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement) are treated as predictive type thermometers and fall under the scope of this standard. This document specifies additional disclosure requirements. This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59. |
| Keywords: | Accessories|Basic safety|Body temperature|Classification|Cleaning|Clinical investigation instruments|Clinical thermometers|Construction requirements|Controls|Definitions|Design|Disinfection|Electric appliances|Electrical|Electrical appliances|Electrical engineering|Electrical measuring instruments|Electrical medical equipment|Electrical protection equipment|Electrical safety|Electrical thermometers|Electromedicine|Environmental requirements|Extrapolation|Features|Fever thermometers|Fitness for purpose|Hazards|Human body|Human medicine|Information supplied by the manufacturer|Inspection|Instructions for use|Marking|Measuring accuracy|Measuring ranges|Mechanical safety|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Operational instructions|People|Protection against electric shocks|Protective devices|Safety|Safety engineering|Safety requirements|Specification (approval)|Systems|Temperature|Temperature measurement|Temperature measuring device|Temperature-measuring instruments|Testing|Thermometers|Time response|Units |
| ICS: | 11.040.55 - Equipo de diagnóstico |
| CTN: |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
