To carry out any procedure, the described routes of application require technically qualified personnel, as well as a written informed consent, followed by strict measures of asepsis and sterility.
As any another medical practice, all the material used in ozone therapy, be it in contact with patient's tissue or fluids, must be either disposable after only one use, or be sterilized (ex. surgical equipment), and the oxygen-ozone gas mixture must pass an antimicrobial sterile filter(< 20 µm) before administration.
Generator used should be in line with the recommendations of ISCO3.7 Professionals should attend post-graduate formation courses which include basic contents defined by ISCO3.66
Ozone generators: The ozone must be produced by a medically reliable and certified generator, complying as any other medical device with the standards set up by, for example, CE,I CSA, UL. The generator must allow the measurements of precise ozone concentrations (1 µgN/mL- 80 µgN/mL). Within the European Union the generators are obliged to comply with the RoHS directives.6 The generator must produce ozone exclusively from medicinal grade, at least 99.5% pure oxygen, coming from a medical quality certified container.7
Medical grade oxygen should fit the quality standard of the local Pharmacopoeia. If local Pharmacopoeia is not available, the reference Pharmacopoeia should be: European Pharmacopoeia ,8 United States Pharmacopoeia9 or Japanese Pharmacopoeia.1
According to these Pharmacopoeias, the quality criteria are mentioned.11 The machine must be able to generate the therapeutic, i.e. homogeneous oxygen-ozone mixture with a range of ozone concentration between 1µg/NmL and 80 µg/NmL. No other substances besides O2 and O3 may be present in the produced gas mixture. To insure the accuracy of the ozone concentration, the calibration of me ozone generators should be done regularly13, once a year. The medical ozone generators must have a seal of approval or Certification of Medical Device, given by a CE medical device Notified Body or by an equivalent institution.
