EN ISO 21917:2022
(Main)Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21917:2023
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
SIST EN ISO 21917:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 21917:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 21917:2023
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 21917:2023
EN ISO 21917:2022 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 21917:2023
EN ISO 21917:2022 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 21917:2023
---------------------- Page: 6 ----------------------
SIST EN ISO 21917:2023
INTERNATIO
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.