nsBAS EN ISO 18778:2024
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
General information
Status:Project
Number of pages:64
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.10, Anaesthetic, respiratory and reanimation equipment
11.040.55, Diagnostic equipment
11.040.55, Diagnostic equipment
Abstract
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
Lifecycle
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Original document and degree of correspondence
EN ISO 18778:2022, identical
ISO 18778:2022, identical
Relation to BAS standards
Work material
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