As our oxygen generators are dedicated to be used as medical oxygen sources for hospital piping systems, we do have, at Oxyplus Technology, strong requirements of safety and reliability.
For this purpose, the oxygen produced by OXYPLUS generators has been tested by an Independent Laboratory of Test agreed by the French Authorities so as to ensure the highest level of quality to our clients.
| |
As required by Oxygen monography (*) |
OXYPLUS oxygen generators (**) |
| Oxygen % at nominal flow |
90 - 93% |
95 - 99% |
| Carbon Dioxide ('CO2) |
< 300 ppmv |
0.1 ppmv |
| Carbon Monoxide (CO) |
< 5 ppmv |
< 5 ppmv |
| Sulphur Dioxide |
< 1 ppmv |
0 ppmv |
| Nitrogen Monoxide |
< 2 ppmv |
0 ppmv |
| Nitrogen Dioxide |
< 2 ppmv |
0 ppmv |
| Oil |
< 0.1 mg/m3 |
< 0.1 mg/m3 |
| Water dew point |
-48 °C |
-65 °C |
(*) Draft of monography released by the European Pharmacopea
in Jan. 2008
as part of Pharmeuropa
(**) As certified by the LNE, an Independent French Laboratory of Test agreed by.
the French Authorities. LNE report available upon request
OXYPLUS Technologies is supported by the quality system of the NOVAIR Group, which is certified ISO 9001:2000 and ISO 13485:2003 by The Swiss Association for Quality and Management Systems (SQS).
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The Oxyplus Technologies oxygen generators, manufactured by NOVAIR SAS in France, are marked as CE Medical Devices according to the 93/42/CEE european directive related to medical devices.
On top of being compliant with the 93/42/CEE directive, our oxygen generators are also manufactured according the highest standards and norms related to medical systems and among them :
- ISO 10083
Oxygen concentrator supply systems for use with medical gas pipeline
systems
- EN ISO 7396-1
Medical gas piping systems - Part 1 / Pipeline systems for compressed medical gases and vacuum
- EN 60601-1
Medical electric equipment - Part 1 / General requirements for safety
- EN 60601-1-2
Medical electric equipment - Part 1-2 / General requirements for safety - Collateral standard : Electromagnetic compatibility - Requirements and Tests
