According to European Pharmacopeia, the medicinal air is defined as :
' The medicinal air is compressed air with an oxygen value comprised between 20,4% minimum and 21,4% v/v maximum.'
The hospital pharmacist is responsible for the delivery of the gas with the status of medical device, as well as a drug. He is responsible for the quality of the gas that will be administered to the patient. The gas quality may be altered gas between the gas source (for example a bottle) and the point of use. It is therefore necessary, the pharmacist checks the quality of gas at regular intervals, at the point of delivery to the patient.
A check should be done after each new installation or modification as well as in routine at an interval to be determined by the pharmacist.Legal aspect :
-European Directive 93/42/EEG concerning medical devices.
-A mandatory control (pharmacopoeia analysis) should be performed after each new installation or extension (medical gases) as well as routine assessment by the pharmacist. In most cases, minimum 1 per year (2 samples) on all networks.Air specification according to the air medicinal monograph:
Physico-chemical analyzes by EP monograph medicinal air (1238: 01/2008)
| O2 value || 20,4%-21,4% ( v/v) |
| H2O value (Dew point)* || ≤67 ppm v/v ou ≤-40°C |
| CO2 value || ≤500 ppm v/v |
| CO value || ≤ 15 ppm v/v |
| COV value || ≤ 0,1 mg/m3 |
| NO value || ≤2 ppm v/v |
| NO2 value || ≤ 2 ppm v/v |
| SO2 value || ≤1 ppm v/v | BACTERIOLOGIE BPF/GMP EDITION 2011-8 Bis
(ufc = unit forming colony)
| Microbiological contamination || CLASSES BPF |
| Recomended limits when 'in activities' || || || || |
| Air : || A || B || C || D |
| ufc/m3 || < 1 || 10 || 100 || 200 |