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Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
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ISO 80601-2-69:2014 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. ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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Designation Name
SS-EN ISO 80601-2-69:2014
Revision Level
2014 EDITION
Status
Superseded
Publication Date
Aug. 11, 2014
Language(s)
English
Page Count
60
International Equivalent
EN ISO 80601-2-69:2014(IDT); ISO 80601-2-69:2014(IDT)