UNE-EN ISO 80601-2-69:2021

* Scope, object and related standardsIEC 60601-1:2005+A1:2012 , Clause 1 applies, except as follows:ScopeIEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.NOTE 1Such an oxygen concentrator can also be used in professional healthcare facilities.This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.EXAMPLE 1An oxygen concentrator with integrated oxygen conserving equipment [1] function or humidifier function.EXAMPLE 2An oxygen concentrator used with a flowmeter stand.EXAMPLE 3An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases [2].EXAMPLE 4An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. This document does not specify the requirements for oxygen concentrators for use with a medical gas pipeline 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 7.2.13 and 8.4.1 of the general standard.NOTE 2See also 4.2 of the General Standard.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 an oxygen concentrator [as defined in 201.3.202] and its accessories. NOTE 1Accessories are included because the combination of the oxygen concentrator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of an oxygen concentrator.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.