EN ISO 18778:2022

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

Publication date:   Jan 17, 2023

General information

60.60 Standard published   Oct 19, 2022

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment | 11.040.55   Diagnostic equipment

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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.
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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18778:2009

NOW

PUBLISHED
EN ISO 18778:2022
60.60 Standard published
Oct 19, 2022