EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Jul 16, 2014

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

Based on IEC 601-1. Specifies safety requirements for oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a medical gas pipeline system. Replaces the first edition.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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WITHDRAWN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 8359:1996

NOW

WITHDRAWN
EN ISO 8359:2009
99.60 Withdrawal effective
Jul 16, 2014

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 8359:2009/A1:2012

REVISED BY

WITHDRAWN
EN ISO 80601-2-69:2014

Relations

Adopted from ISO 8359:1996 IDENTICAL