ISO 21917:2021
Anaesthetic and respiratory equipment - Voice prostheses

Standard No.

ISO 21917:2021

Release Date

2021

Published By

International Organization for Standardization (ISO)

Latest

ISO 21917:2021

Scope

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.

ISO 21917:2021 Referenced Document

• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
• ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications*， 2024-03-01 Update

ISO 21917:2021 history

• 2021 ISO 21917:2021 Anaesthetic and respiratory equipment - Voice prostheses