Product Product ISO 18778:2022
Price Price $ 189.00
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Description Description

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

Standard Number Standard Number ISO 18778:2022
Title Title ISO 18778:2022 Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
Status Status Published
Publication Date Publication Date 30 Jun 2022
Cross References Cross References
Descriptors Descriptors
ICS ICS 11.040.10
Committee Committee ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 57
File Size File Size KB