ISO 18778:2022

Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

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

Edition	2022
Published Date	2022
Published By	International Standardization Organisation
Page Count	57