Standards Development

Scope

This document applies to the basic safety and essential performance of infant cardiorespiratory monitors, as defined in 201.3.201, 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 Infant cardiorespiratory monitors 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 monitors, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitors.

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. This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of document.

Purpose

The object of this document is to establish particular basic safety and essential performance requirements for infant cardiorespiratory monitors, as defined in 201.3.201, and its accessories.

NOTE 1 Accessories are included because the combination of the infant cardiorespiratory monitors 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 monitors.

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 DD.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [6] as indicated in Annex EE.

This document specifies requirements for infant cardiorespiratory monitors called in previous working documents “infant apnoea monitors or infant monitors”. Infant cardiorespiratory monitors are intended to be used primarily to monitor cardiorespiratory parameters for patients less than 3 years of age. Infant cardiorespiratory monitors are required include at least one direct measurement of respiration and one indirect measurement of apnoeic activity such as heart rate or oxygen saturation. Infant cardiorespiratory monitors are intended for use in the home healthcare environment. Infant cardiorespiratory monitors are frequently used in locations where supply mains is not reliable. Infant cardiorespiratory monitors are often supervised by non-healthcare personnel (lay operators) with varying levels of training. Infant cardiorespiratory monitors conforming with this document can be used elsewhere (i.e., in healthcare facilities). Infant cardiorespiratory monitors conforming with this document can be used with other patient populations (i.e., adult).

This is intended to replace the non-state of the art current standard, (EN) ISO 18778:2007, Respiratory equipment -- Infant monitors -- Particular requirements.

The object of this document is to establish particular basic safety and essential performance requirements for infant cardiorespiratory monitors, as defined in 201.3.201, and its accessories.

NOTE 1 Accessories are included because the combination of the infant cardiorespiratory monitors 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 monitors.

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 DD.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [6] as indicated in Annex EE.

This document specifies requirements for infant cardiorespiratory monitors called in previous working documents “infant apnoea monitors or infant monitors”. Infant cardiorespiratory monitors are intended to be used primarily to monitor cardiorespiratory parameters for patients less than 3 years of age. Infant cardiorespiratory monitors are required include at least one direct measurement of respiration and one indirect measurement of apnoeic activity such as heart rate or oxygen saturation. Infant cardiorespiratory monitors are intended for use in the home healthcare environment. Infant cardiorespiratory monitors are frequently used in locations where supply mains is not reliable. Infant cardiorespiratory monitors are often supervised by non-healthcare personnel (lay operators) with varying levels of training. Infant cardiorespiratory monitors conforming with this document can be used elsewhere (i.e., in healthcare facilities). Infant cardiorespiratory monitors conforming with this document can be used with other patient populations (i.e., adult).

This is intended to replace the non-state of the art current standard, (EN) ISO 18778:2007, Respiratory equipment -- Infant monitors -- Particular requirements.