DIN Standards Committee Health Technologies
DIN 13200-2
Voice prostheses - Part 2: General requirements; Text in German and English
Stimmprothesen - Teil 2: Allgemeine Anforderungen; Text Deutsch und Englisch
Overview
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 have to seal the TEP safely during swallowing. The standard specifies general requirements on voice prostheses. This includes requirements on voice prostheses supplied sterile, requirements on marking and labeling as well as requirements on information to be provided by the manufacturer. 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).
