DIN 13200-1:2015-06

Voice prostheses are used to restore voice in patients after total laryngectomy. Voice prostheses have three essential functions: - they prevent spontaneous closure of the TEP; - they allow airflow into the pharynx for the creation of speech; - they shall seal the TEP safely. The standard specifies general requirements on voice prostheses. This standard specifies test methods used for the evaluation of the following physical characteristics of voice prostheses: - valve leak tightness; - valve opening pressure; - flow rate/pressure drop characteristic. The test for valve leak tightness is performed via the evaluation of a leakage rate at a defined pressure on the oesophageal side of the prosthesis. For the test for valve opening pressure, the tracheal side of the prosthesis is subjected to an increasing static pressure at a constant gradient and the opening pressure is detected via the step change in volume flow rate. The test is performed on a wetted voice prosthesis. The flow rate/pressure drop characteristic curve is determined by measuring the static pressure difference between the tracheal side of the prosthesis and ambient pressure for several defined air volume flow rates. The standard has been prepared by NA 053-03-02 AA "Medizinprodukte für das Atemwegssystem" ("Airways and related equipment") at the DIN Standards Committee Rescue Services and Hospital (NARK).