Projet
Norme internationale
ISO/DIS 12487
Titre manque
Numéro de référence
ISO/DIS 12487
Edition 1
Projet Norme internationale
ISO/DIS 12487
85205
Projet de Norme internationale au stade enquête auprès des membres de l’ISO.

Résumé

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.

NOTE           For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient.

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.

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