Compression

Health insurance companies in Germany reimburse products that carry the RAL quality mark. This is awarded for external exams. More about at the Hohenstein institute that the "HOSY" test device is used for this purpose. A human-ecological harmlessness must also be verified, e.g. through OEKO-TEX® Standard 100 of product class II or an equivalent certificate. There are also requirements for labeling, packaging and instructions for use. More on this at the  Quality Association for Medical Compression Stockings e.V.

With the entry in the resource directory, each product receives an individual resource number for billing with the cost bearers. More about this at the KGV-Spitzenverband.

Directive 93/42 / EEC applies to Medical devices (MD). This will be replaced in 2021 by the new regulation EU 2017/745, which will apply from May 26, 2021. It is implemented in German law with the Medical Devices Act MPG. Medical devices are classified into classes I, IIa, IIb and III according to their hazard potential.

Medical Compression stockings are assigned to class I. Here the manufacturer declares in writing under his own responsibility the conformity, that the safety and health requirements are met. The CE mark does not represent a seal of quality or a test seal, but serves as an administrative mark that expresses the free market capability in the European internal market.

The ISO 13485 standard has to be confirmed by manufacturers of medical products through initial certification and later through regular audits.

A conclusion: the compression stocking requires mobility in order to be effective, whereas the construction principle of the thrombosis prophylaxis stocking is geared towards the patient's immobility.

Support stockings should not be used for prophylaxis or for the treatment of venous diseases. They are primarily used to prevent "heavy legs" in people with healthy veins. *

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* Taken from the brochure "Physical thromboembolism prophylaxis in the inpatient and outpatient sector" page 14, published by BVmed