60.60 Standard published Jun 30, 2022
ISO
ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
International Standard
11.040.10 Anaesthetic, respiratory and reanimation equipment | 11.040.55 Diagnostic equipment
Published
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
WITHDRAWN
ISO 18778:2005
PUBLISHED
ISO 18778:2022
60.60
Standard published
Jun 30, 2022
