EN ISO 21917:2022 PDF

Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)

Название (английский):

EN ISO 21917:2022

Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 21 декабря 2022 г.
Издание:: CEN EN 21917 edition 1 version 1
ICS:: 11.040.10

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Описание (английский):

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.

Технические детали

Технический комитет: CEN/TC 215 - Respiratory and anaesthetic equipment
SKU: EN ISO 21917:2022

Abstract

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

Overview

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

EN ISO 21917:2022 PDF

Технические детали

Abstract

Overview

Key topics and requirements

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Abstract

Overview

Key topics and requirements

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