NF EN 12470-3+A1
Clinical thermometers - Part 3 : performance of compact electrical thermometers (non-predictive and predictive) with maximum device
Le présent document spécifie les exigences de performance relatives aux thermomètres médicaux électriques compacts avec dispositifs à maximum (à comparaison et à extrapolation).
Le présent document spécifie les exigences de performance relatives aux thermomètres médicaux électriques compacts avec dispositifs à maximum (à comparaison et à extrapolation).
Le présent document spécifie les exigences de performance relatives aux thermomètres médicaux électriques compacts avec dispositifs à maximum (à comparaison et à extrapolation).
ISO 80601-2-56:2009 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2009 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2009 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2009 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2009. Requirements for ME equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601‑2‑59:2008 and such ME equipment is not covered by ISO 80601-2-56:2009.
- Avant-propos3
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1 Domaine d'application4
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2 Références normatives4
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3 Termes et définitions4
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4 Unités5
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5 Types de thermomètres5
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6 Exigences relatives aux performances5
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7 Méthodes d'essai8
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8 Informations fournies par le fabricant12
- Annexe A (informative) Types d'essais recommandés pour les exigences de la présente norme14
- Annexe B (informative) Bibliographie16
- Annexe ZA (informative) A1 Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE17
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