CEN/TC 215
| Project No. | LVS EN ISO 18778:2023 |
|---|---|
| Title | 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 MEsystems 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. |
| Registration number (WIID) | 71656 |
| 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 MEsystems 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. |
| Status | Standarts spēkā |
| ICS group | 11.040.55 11.040.10 |