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Normas DIN – AENOR
DIN EN ISO 80601-2-56/A1:2018-04

DIN EN ISO 80601-2-56/A1:2018-04

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/DAM 1:2018); German and English version EN ISO 80601-2-56:2017/prA1:2018 / Note: Date of issue 2018-03-09

Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps - Amendement 1 (ISO 80601-2-56:2017/DAM 1:2018); Version allemande et anglaise EN ISO 80601-2-56:2017/prA1:2018 / Attention: Date de parution 2018-03-09

Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur - Änderung 1 (ISO 80601-2-56:2017/DAM 1:2018); Deutsche und Englische Fassung EN ISO 80601-2-56:2017/prA1:2018 / Achtung: Erscheinungsdatum 2018-03-09

Fecha Anulación:
2020-08 /Withdrawn
Equivalencias internacionales:

EN ISO 80601-2-56/prA1 (2018-02)

ISO 80601-2-56 DAM 1 (2018-03)

Relación con otras normas DIN:
Resumen:
This standard specifies the general, metrological and technical requirements for electrical clinical thermometers. This standard applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. The clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create medical electrical systems. This standard does not apply to such accessories. Medical electrical equipment that measures a temperature as a secondary function is outside the scope of this standard. Requirements for medical electrical equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59.
Keywords:
Accessories, Basic safety, Body temperature, Classification, Cleaning, Clinical investigation instruments, 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
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