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EVS-EN ISO 8359:2009/A1:2012

Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)

General information
Withdrawn from 04.08.2014
Base Documents
ISO 8359:1996/Amd 1:2012; EN ISO 8359:2009/A1:2012
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Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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
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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EVS-EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements
Newest version Withdrawn from 04.08.2014