DANSK DSF/ISO/DIS 18778 PDF

201.1 Scope, object and related standards 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 cardiorespiratory monitor, as defined in 201.3.203, hereafter also r 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 re under three years of age; and – intended for transit-operable use. NOTE – 1 An infant cardiorespiratory monitor can also be used in professional health car This document is also applicable to those accessories intended by their man connected to the infant cardiorespiratory monitor, where the characteri accessories can affect the basic safety or essential performance o cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system If a clause or subclause is specifically intended to be applicable to ME equi to ME systems only, the title and content of that clause or subclause will sa not the case, the clause or subclause applies both to ME equipment and to relevant. Hazards inherent in the intended physiological function of ME equipment within the scope of this document are not covered by specific require 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.