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.
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.
Informaciones generales
-
Estado: En desarrollo
Puede contribuir al desarrollo del borrador de esta norma internacional. Para ello, contacte con su miembro nacional
Etapa: Voto sobre el DIS iniciado: 12 semanas [40.20] -
Edición: 1Número de páginas: 24
-
Comité Técnico :ISO/TC 121/SC 3ICS :11.040.55
- RSS actualizaciones