Compression therapy: European regulatory affairs

Objective: Updating the status of the European standardisation for medical elastic compression stockings, including custom-made stockings (class 03060 6, EN29999), knitted from threads made of natural fibres or synthetic fibre s and elastic threads. Design: Review of the literature. Setting: Department of Dermatology at the University Hospital of Maastricht (The Netherlands). Methods: Systematic review of the European regulations within the European Committee for Standardisation (CEN), by a special committee researching non -active medical devices (CEN/TC205). A special working group was set up for medical elastic compression stockings (CEN/TC205/WG2) and for anti-embolis m stockings (CEN/TC205/WG2/P1) linked to the scientific background and lite rature on medical elastic compression stockings. Results: CEN/TC205 formalised a European pre-standard (prEN12718) for medic al elastic compression stockings. The pre-standard describes five compressi on classes, instructions for measurement, instructions for residual pressur e and instructions for knitting. Still lacking is a good instrument for the comparison of laboratory measurements and a durability test. The problem o f the elasticity coefficient is neglected in the standard. Conclusions: Normalisation of non-active medical devices is an important qu ality instrument. The medical profession should give attention to adequate compression classes, a good understanding of the elasticity coefficient and the durability of stockings.