EC conformity declaration / quality standards
All TSM supports, whether intended for medical use or not, are developed and manufactured in accordance with the requirements laid down in 93/42/EEC and the MPG (German medical product legislation) and in 89/686/EEC (personal protection equipment). They are subject to constant quality testing in line with the DIN EN ISO 9000 ff standard. "TSM supports" thus bear the CE marking.
A copy of the instructions for use, which also includes the warranty notes and instructions on how to apply certain supports is packed with all supports. This information must be handed over to patients/customers in accordance with EU legislation.
The zytotoxic potential (effect with regard to cell damage) of TSM supports has been investigated as part of the CE certification process, as were skin irritation and sensibilization. The tests were carried out by a respected, independent German institute.
Under the conditions of testing, it was proven that no zytotoxic effects,
and no skin irritation or sensibilization occurred.