BS EN ISO 21917:2022(2023)
Anaesthetic and respiratory equipment — Voice prostheses

Standard No.

BS EN ISO 21917:2022(2023)

Release Date

1970

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 21917:2022(2023)

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.

BS EN ISO 21917:2022(2023) Referenced Document

• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1*， 2009-12-01 Update
• ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment*， 2016-11-01 Update
• ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications*， 2024-03-01 Update

BS EN ISO 21917:2022(2023) history

• 0000 BS EN ISO 21917:2022(2023)
• 2023 BS EN ISO 21917:2022 Anaesthetic and respiratory equipment. Voice prostheses