UNE-EN ISO 18778:2022

Clause 1 of the general standard, applies, except as follows.

NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.

201.1.1 Scope

Replacement:

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 201.3.203, 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 1 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

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is

not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this

document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

201.1.2 Object

Replacement:

The object of this document is to establish particular basic safety and essential 235 performance requirements for an infant cardiorespiratory monitor, as defined in 201.3.203, and its accessories.

Accessories are included because the combination of the infant cardiorespiratory monitor and the accessories needs to be adequately safe. Accessories can have a significant impact

on the basic safety or essential performance of the infant cardiorespiratory monitor.

NOTE 1 This document has been prepared to address the relevant essential principles[6] and labelling[7] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex DD.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex EE.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[8] as indicated in Annex FF.