EN ISO 8359:1996

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

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Apr 8, 2009

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

ISO 8359 is one of a series of International Standards based on IEC 601-1. In IEC 601-1 (the "General Standard"), this type of international Standard is referred to as a Particular Standard". As stated in 1.3 of IEC 601-1:1998, the requirements of this International Standard take precedence over those of IEC 601-1. The scope and object given in clause 1 of IEC 601-1:1998 apply, except that 1.1 shall be replaced by the following: This International Standard specifies safety requirements for continous-flow oxygen concentrators. This International Standard does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents. The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing absorbes, as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN ISO 8359:1996
99.60 Withdrawal effective
Apr 8, 2009

REVISED BY

WITHDRAWN
EN ISO 8359:2009