ISO 18778:2022

International Standard   Current Edition

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

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

Prepare
30 June 2022
Anaesthetic, respiratory and reanimation equipment
Including medical gas installations
Diagnostic equipment
Including medical monitoring equipment, medical thermometers and related materials

Files

null Pages
Current Edition
 

Related Standards

revises
ISO 18778:2005
 
Historical
International Standard
Respiratory equipment — Infant monitors — Particular requirements

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