EN ISO 21917:2022 PDF

Overview

EN ISO 21917:2022 / ISO 21917:2021 - "Anaesthetic and respiratory equipment - Voice prostheses" - is a device-specific international standard adopted by CEN that defines performance, safety, packaging and information requirements for voice prostheses used after total laryngectomy. The standard specifies manufacturer responsibilities, test methods to evaluate physical characteristics, and criteria that support safe clinical use of tracheoesophageal voice prostheses.

Key topics and requirements

• Scope and purpose: Performance requirements for voice prostheses, plus requirements for marking, sterile packaging and manufacturer information (instructions for use).
• Design and function: Defines essential functions (prevent spontaneous TEP closure, allow phonatory airflow, seal during swallowing) and key design features such as tracheal and oesophageal flanges and one‑way valve operation.
• Materials and biocompatibility: Materials must meet general requirements in ISO 18190 and biological safety of breathing gas pathways is assessed per ISO 18562‑1.
• Performance tests (Annex B) - included type test methods to evaluate:
  • Leakage: valve leakage is specified; the standard requires leakage