ISO 18778:2022

Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
Autor: ISO
Códigos ICS: 11.040.10 ; 11.040.55


This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:—    intended for use in the home healthcare environment;—    intended for use by a lay operator;—    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and—    intended for transit-operable use.NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities.This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.EXAMPLE        probes, cables distributed alarm system

Especificaciones de la Norma
Fecha de Publicación 30/06/2022
Título Secundario Matériel respiratoire — Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs cardiorespiratoires pour nourrissons
Páginas Técnicas 57
Idioma Inglés