SSH EN ISO 18778:2022

Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)

Scope

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.