EN ISO 80601-2-69:2014

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

Publication date:   Sep 19, 2014

General information

99.60 Withdrawal effective   Nov 18, 2020

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

2007/47/EC

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8359:2009

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EN ISO 8359:2009/A1:2012

NOW

WITHDRAWN
EN ISO 80601-2-69:2014
99.60 Withdrawal effective
Nov 18, 2020

REVISED BY

PUBLISHED
EN ISO 80601-2-69:2020