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Products I Quality management

Quality assurance
The high reactivity of ozone with inorganic and especially organic substances requires a careful selection of materials needed for the different types of medical equipment and disposables:

Only special materials can be used in ozone generators, such as Teflon (PTFE), specially anodized aluminium, V4A quality stainless steel (in long-term use, V2A quality is subject to surface changes), glass and ceramics.

For application systems only "ozone-resistant" materials such as glass, polyethylene (PE), polypropylene (PP) and PTFE may be considered.

Other plastics, especially for syringe pistons, must be silicone-coated.

Medical plasma flasks as used for reinfusion should be made of glass only. Only latex-free plugs should be used (latex allergies!). Plasma bags or blood bags made of non-ozone-resistent, soft polyvinylchloride (PVC) must not be used. Reactions between ozone and these materials can occur producing xenobiotic and/or toxic substances, especially during O3 blood treatment requiring up to 5 minutes to obtain the proper effect. The substances arising from a decomposition of the softening agents in the plastic, such as e.g. hydrogen peroxide or phthalic acid esters are not only able to distort the desired effects of ozone, but also damage the patient's health.

For preparing and storing ozonized water, containers made exclusively of glass are to be used. These must have as small a volume (e.g. 250 ml) as possible; they should be completely filled and well sealed with O3-resistant material.

Use sterile, siliconized, 50-ml disposable syringes (measured ozone half life: 55 min) to transport ozone/oxygen mixtures for use during home visits.

Ozone generators as well as all the disposables used for treatment have to fulfil the MDD (Medical Device Directives) in Europe (93/42 EC) and are labelled with a “CE ” sign including the number of the supervising authorities. Manufacturers must possess detailed and valid certificates.

Dr. Hänsler Ozonosan is approved according to MDD 93/42EWG and DIN EN ISO 13485 and guarantees with its products Quality and Safety in Ozone Therapy.

New TÜV Certificates

TÜV Certificate Q5 098154 002 0001 Rev.01
Design and Manufacture, Service and Distribution of Ozone Generators and Associated Disposables
Certificate (PDF)

TÜV Certificate G1 098154 0001 Rev.01
Ozone generators, sterile vacuum bottles and sterile transfer filter set for Ozone-Oxygen-Therapy
Certificate (PDF)