CERTIFICATES OF QUALITY ASSURANCE

OEKO-TEX
It guarantees the absence of harmful substances in our garments that are tested annually by the Trial Institute Hohenstein in Germany. This certificate is a guarantee of the quality and safety of our products. All garments are Latex-free.

ISO 13485:2016
LIPOELASTIC products are manufactured in a production facility which meets quality management requirements for ISO 13485.

DECLARATION OF CONFORMITY
LIPOELASTIC® products meet the requirements of the Medical Device Directive 93/42/EEC and the  Government Regulation No. 336/2004 as amended. The LIPOELASTIC® products are authorized to use the CE mark.

OUR PRODUCTS ARE LISTED AND MONITORED BY THE FDA AS A CLASS DEVICE 1

CERTIFICATION OF MATERIAL

Top-quality materials, custom-made by producers in EU, are used for LIPOELASTIC® garments. All materials are regularly tested at the Textile Testing Institute TZÚ in Brno - Czech Republic.

The key criteria, carefully monitored, are the parameters of longitudinal and cross-section compression of textiles. These tests are carried out in accordance with the methods of the company DuPont, a world-renowned producer of elastic fibers under the Lycra trademark.

These regular tests enable us to guarantee our partners the required compression of garments ranging from 17-22 mmHg. The individual garment types are put on torsos simulating particular body parts and continuously tested using the measuring device MST MK IV from the Swiss producer Swisslastic AG.

Another significant testing parameter is the body moisture taken away from the skin in accordance with the standard EN 16422 and ATTCC 195-2009. We guarantee a first-rate coefficient of the textile material’s ability to take moisture away from the body surface.

The textiles used increase user comfort in wearing LIPOELASTIC® garments and this is what makes us unique in comparison to our competitors. Our new collection, Unique, is, in particular, without comparison worldwide.

Additional parameters, which we regularly test, are as follows: antibacterial activity, strength in tear and color constancy of the textiles.
We constantly meet these parameters as well.
The unique textile treatment using particles of silver Ag, prevents the possible occurrence of infectious complications in postoperative care. Silver particles support the healing process and prevent the spread of the bacteria Klebsiella pneumoniae and Staphylococcus aureus. Again, our competitors lack this bonus.

	High anti-bacterial activity - SILVER PROTECT® The protection SILVER PROTECT® prevents the growth of bacteria on skin after surgery.
	Permeability of moisture evaporation The Top-most resistance according to CSN EN 31092 standard is between 2-3 m2Pa/W. LIPOELASTIC® material meets the ideal value 2.57 m2Pa/W.
	Conveyance and management of perspiration The value of perspiration conveyance between 800 – 900 g/m2H is first-rate. The results of LIPOELASTIC® materials reach the value 815 g/m2H.
	Moisture control Tests results showed that the moisture control with LIPOELASTIC® material is 85%. This result provides the patient with the feeling of dryness during wear.