UNE-EN ISO 80601-2-67:2021

Scope, object and related standardsEN 60601-1:2005+Amd1:2012, clause 1 applies, except as follows:ScopeIEC 60601-2:2005+AMD1:2012, 1.1 is replaced by:This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accesories intended to conserve supplemental oxigen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used ty a lay operator.Note 1 Conserving equipment can also be used in profesional health care facilitesNota 2 Conserving equipment can be used with an oxygen concentratorThis document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas)NOTE 3Conserving equipment conforming with this document can be incorporated with other devices that have their own standards, in which case the combination needs to conform with both standards.EXAMPLESConserving equipment combined with a pressure regulator (ISO 10524 series), an oxygen concentrator[2] or liquid oxygen equipment[3].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 4Additional 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 standards.ObjectIEC 60601-1:2005, 1.2 is replaced by:The object of this document is to establish particular basic safety and essential performance requirements for conserving equipment [as defined in 201.3.201] and its accessories. NOTE 1Accessories are included because accessories can have a significant impact on the basic safety or essential performance of conserving equipment.NOTE 2This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex BB.NOTE 3This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 as indicated in Annex CC.