Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
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 MEΒ equipment, in combination with its accessories:
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
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