This standard BS EN ISO 21917:2022 Anaesthetic and respiratory equipment. Voice prostheses is classified in these ICS categories:
11.040.10 Anaesthetic, respiratory and reanimation equipment
11.040.40 Implants for surgery, prosthetics and orthotics
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.
