scope:

This part of DIN 13200 specifies three test methods used for the evaluation of physical characteristics of voice prostheses:

- test method for the evaluation of the valve leak tightness;

NOTE 1 The valve leak tightness provides information about the basic functionality (one-way function of the valve) of the prosthesis.

- test method for the evaluation of the valve opening pressure;

NOTE 2 The valve opening pressure is used to evaluate the valve closing force and the ability to withstand underpressure phenomena which could cause leaking/aspiration during swallowing and inspiration.

- test method for the evaluation of the flow rate/pressure drop characteristic.

NOTE 3 The flow rate/pressure drop characteristic curve allows an assessment of the air flow resistance of the prosthesis during speech.

The test methods specified in this part of DIN 13200 are intended to be type tests.

NOTE 4 General requirements on voice prostheses, including requirements on marking and labeling as well as information to be provided by the manufacturer are included in DIN 13200-2.