SIST EN ISO 21917:2023

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

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.

Anästhesie- und Beatmungsgeräte - Stimmprothesen (ISO 21917:2021)

Matériel d'anesthésie et de réanimation respiratoire - Implants phonatoires (ISO 21917:2021)

Le présent document spécifie les exigences de performances des implants phonatoires, y compris les exigences relatives au marquage, à l’emballage et aux informations à fournir par le fabricant ainsi que les méthodes d’essai pour l’évaluation des caractéristiques physiques des implants phonatoires.
NOTE          Des recommandations ou des justifications relatives à cet élément de liste figurent en A.2.

Anestezijska in dihalna oprema - Govorne proteze (ISO 21917:2021)

Ta dokument določa zahteve za delovanje glasovnih protez, vključno z zahtevami za označevanje in pakiranje ter za informacije, ki jih mora zagotoviti proizvajalec, ter preskusne metode za ocenjevanje fizikalnih lastnosti glasovnih protez.
OPOMBA:   Za to točko seznama obstajajo smernice ali utemeljitev v A.2.

General Information

• Status: Published
• Public Enquiry End Date: 30-Oct-2022
• Publication Date: 14-Mar-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 21-Feb-2023
• Due Date: 28-Apr-2023
• Completion Date: 15-Mar-2023
• Ref Project: EN ISO 21917:2022 - Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)

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 < 100 ml/min (tested per B.3).
  • Valve opening pressure: assesses the minimal pressure to open the valve to resist aspiration and swallowing forces.
  • Characteristic curve: pressure–flow relationship to evaluate airflow resistance during speech.
• Packaging and sterilization: Requirements reference ISO 11607‑1 for terminally sterilized medical devices where applicable.
• Information and labelling: Required marking and instructions to support correct clinical use, replacement intervals and safe handling.
• Annex A (informative): Rationale and explanatory material to support application and future revision.

Applications and users

Who uses EN ISO 21917:2022:

• Manufacturers and R&D teams designing or improving voice prostheses - to guide product performance, bench testing and technical documentation.
• Regulatory and quality assurance personnel - to demonstrate conformity, prepare technical files and support CE marking/national approvals.
• Clinical users (ENT surgeons, speech‑language pathologists, prosthesis fitters) - for understanding device function, safe selection and intended use.
• Test laboratories - for performing standardized type tests (leakage, opening pressure, characteristic curve).
• Procurement and hospital safety teams - to evaluate device specifications, sterile packaging and labeling compliance.

Related standards

• ISO 18190 - General requirements for airways and related equipment (device-specific requirements in ISO 21917 take precedence).
• ISO 18562‑1 - Biocompatibility evaluation of breathing gas pathways.
• ISO 11607‑1 - Packaging for terminally sterilized medical devices.

Keywords: EN ISO 21917:2022, ISO 21917:2021, voice prostheses, tracheoesophageal puncture, valve leakage, opening pressure, characteristic curve, sterile packaging, biocompatibility.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2023
Anestezijska in dihalna oprema - Govorne proteze (ISO 21917:2021)
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
Anästhesie- und Beatmungsgeräte - Stimmprothesen (ISO 21917:2021)
Matériel d'anesthésie et de réanimation respiratoire - Implants phonatoires (ISO
21917:2021)
Ta slovenski standard je istoveten z: EN ISO 21917:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21917
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.40
English Version
Anaesthetic and respiratory equipment - Voice prostheses
(ISO 21917:2021)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Stimmprothesen
Implants phonatoires (ISO 21917:2021) (ISO 21917:2021)
This European Standard was approved by CEN on 18 December 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21917:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 21917:2021 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 21917:2022 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21917:2021 has been approved by CEN as EN ISO 21917:2022 without any modification.

INTERNATIONAL ISO
STANDARD 21917
First edition
2021-08
Anaesthetic and respiratory
equipment — Voice prostheses
Reference number
ISO 21917:2021(E)
©
ISO 2021
ISO 21917:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 21917:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 2
5.1 General . 2
5.2 Biological safety of gas pathways . 2
6 Design requirements . 2
6.1 General requirements . 2
6.2 Valve leakage . 2
6.3 Valve opening pressure . 3
6.4 Characteristic curves . 3
7 Requirements for voice prostheses supplied sterile . 3
8 Packaging of voice prostheses supplied sterile . 3
9 Information supplied by the manufacturer . 3
9.1 General requirements . 3
9.2 Marking . 3
9.3 Instructions for use . 4
Annex A (informative) Rationale . 5
Annex B (normative) Test methods . 6
ISO 21917:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airways and related equipment and is written following the format of
ISO 18190 General standard for airways and related equipment. The requirements in this device-specific
standard take precedence over any conflicting requirements in the general standard.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

ISO 21917:2021(E)
Introduction
Voice prostheses are used to restore voice in patients after total laryngectomy. They are placed into
a surgically created tracheoesophageal puncture (TEP). The placement can be performed during
the laryngectomy (primary placement), later after healing as an endoscopic procedure (secondary
placement) or in order to replace a voice prosthesis (replacement procedure). There exist different
prosthesis specific placement tools to insert a voice prosthesis into the TEP. Placement of the voice
prosthesis can be performed via the tracheostoma (anterograde), via the mouth (retrograde) and via the
surgical wound (intraoperative).
Voice prostheses have three essential functions:
— they prevent spontaneous closure of the TEP;
— they allow airflow into the pharynx for the creation of speech;
— they seal the TEP during swallowing.
Safe retention of the voice prosthesis is achieved by the oesophageal and tracheal flanges. The
oesophageal flange is placed into the oesophagus, the tracheal flange is placed in the trachea. In order
to prevent leakage of food and saliva into the trachea voice prostheses have a one-way valve that opens
in the direction of the oesophagus.
Voice prostheses have a limited service life and have to be replaced if they start leaking or if they are
overgrown with a biofilm.
There are two groups of voice prostheses:
— indwelling voice prostheses, and
— non-indwelling voice prostheses.
Indwelling voice prostheses are placed by a professional (e.g., speech-language pathologist, physician)
and left in the TEP until they fail. They are then replaced.
Non-indwelling voice prostheses are replaced by the patient himself after a certain training period.
The following three most common test methods have been included to determine:
a) Leakage, which provides information about the basic one-way function of the voice prosthesis valve.
b) The valve opening pressure, which evaluates the ability of the valve to withstand phenomena that
can cause leaking/aspiration during swallowing and inspiration.
c) Characteristic curve, which allows an assessment of the air flow resistance of the voice prosthesis
during speech.
Annex A contains rationale statements for some of the requirements of this document and
recommendations that have been incorporated into this document. It is considered that knowledge of
the reasons for the requirements and recommendations will not only facilitate the proper application of
this document but will expedite any subsequent revisions.
Throughout this document the following print types are used:
— Requirements and definitions: roman type.
— Informative material appearing outside of tables, such as notes, examples and references: smaller
type.
— Terms defined in Clause 3: italic type.
INTERNATIONAL STANDARD ISO 21917:2021(E)
Anaesthetic and respiratory equipment — Voice
prostheses
1 Scope
This document specifies performance requirements for voice
...