Compression Therapy: European Regulatory Affairs

Abstract

Objective:

Updating the status of the European standardisation for medical elastic compression stockings, including custom-made stockings (class 030606, EN29999), knitted from threads made of natural fibres or synthetic fibres 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-embolism stockings (CEN/TC205/WG2/P1) linked to the scientific background and literature on medical elastic compression stockings.

Results:

CEN/TC205 formalised a European prestandard (prEN12718) for medical elastic compression stockings. The pre-standard describes five compression classes, instructions for measurement, instructions for residual pressure and instructions for knitting. Still lacking is a good instrument for the comparison of laboratory measurements and a durability test. The problem of the elasticity coefficient is neglected in the standard.

Conclusions:

Normalisation of non-active medical devices is an important quality instrument. The medical profession should give attention to adequate compression classes, a good understanding of the elasticity coefficient and the durability of stockings.