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EVS-EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements

General information
Withdrawn from 04.08.2014
Base Documents
ISO 8359:1996; EN ISO 8359:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history
Status
Date
Type
Name
04.08.2014
Main
05.09.2012
Amendment
04.06.2009
Main
Main
EVS-EN ISO 8359:1999
This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators in- tended 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.
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Amendment

EVS-EN ISO 8359:2009/A1:2012

Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
Newest version Withdrawn from 04.08.2014