Voice prostheses - Part 2: General requirements; Text in German and English
|Publication Date:||1 June 2015|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This part DIN 13200 specifies general requirements on voice prostheses including requirements on marking and labeling as well as on information to be provided by the manufacturer.
NOTE 1 Test methods used for the evaluation of physical characteristics of voice prostheses are specified in DIN 13200-1.
NOTE 2 If required by local competent authorities, additional and/or other regional and/or national regulation and/or standards can apply.