ISO 21917:2021 PDF
Anaesthetic and respiratory equipment — Voice prostheses
Anaesthetic and respiratory equipment — Voice prostheses
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 12
- Дата публикации:
- 13 августа 2021 г.
- Издание:
- ISO IS 21917 edition 1 version 1
- ICS:
- 11.040.10
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.
Abstract
Overview
ISO 21917:2021 - Anaesthetic and respiratory equipment - Voice prostheses - specifies performance, marking, packaging and information requirements for medical voice prostheses used to restore speech after total laryngectomy. The standard sets device-specific requirements and test methods for key physical characteristics (valve leakage, valve opening pressure, characteristic curves), and references general airway requirements and packaging/biocompatibility standards.
Key topics and requirements
- Scope & purpose: Defines voice prosthesis functions (prevent TEP closure, allow airflow for speech, seal during swallowing) and device groups (indwelling and non‑indwelling).
- Design and performance:
- Valve leakage: leakage through the valve shall be **
Технические детали
- Технический комитет
- ISO/TC 121/SC 2 - Airways and related equipment
- SKU
- ISO 21917:2021
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