DIN EN ISO 80601-2-56:2026-01
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO/DIS 80601-2-56:2025); German and English version prEN ISO 80601-2-56:2025 / Note: Date of issue 2025-12-05*Intended as replacement for DIN EN ISO 80601-2-56 (2020-08).
| Fecha edición: |
2026-01-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as ME equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document only applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. This document is also applicable to those accessories intended by their manufacturer to be connected to the clinical thermometer, where the characteristics of those accessories can affect the basic safety or essential performance of the clinical thermometer. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. This document does not apply to auxiliary equipment. Me equipment that measures the temperature of a patient is within the scope of this document. This document does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of humans under indoor environmental conditions, whose laboratory accuracy requirements are described in IEC 80601?2?59. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601?1:2005+A1:2012, 7.2.13 and 8.4.1. |
| 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, 17.200.20 - Instrumentos de medida de temperatura |
| CTN: |
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