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EN ISO 16628:2022

(Main)

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document

Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)

Dieses Dokument legt Anforderungen bezüglich Sicherheit, Werkstoffe, Konstruktion und Informationen fest, die mit Tracheobronchialtuben geliefert werden. Diese Geräte werden verwendet, wenn die Isolierung der Atemwege eines oder beider Lungenflügel erforderlich ist.
Trachealtuben mit Bronchusblockern sind vom Anwendungsbereich dieses Dokuments ausgeschlossen.

Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO 16628:2022)

Le présent document spécifie les exigences relatives à la sécurité, aux matériaux, à la conception et aux informations fournies avec les sondes trachéobronchiques. Ces dispositifs sont utilisés lorsqu’il est nécessaire d’isoler les voies aériennes d’un poumon ou des deux poumons.
Les sondes trachéales qui incluent des bloqueurs bronchiques sont exclues du domaine d’application du présent document.

Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)

Ta dokument določa zahteve za varnost, materiale, zasnovo in informacije, ki so priložene traheobronhialnim cevkam. Ti pripomočki se uporabljajo, kadar je treba izolirati dihalne poti enega ali obeh pljučnih
kril.
Trahealne cevke, ki vključujejo bronhialne zaviralce, ne spadajo na področje uporabe tega dokumenta.

General Information

Status
Published
Publication Date
05-Jul-2022
Withdrawal Date
30-Jan-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
06-Jul-2022
Completion Date
06-Jul-2022
Ref Project
SIST EN ISO 16628:2022 - Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

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SLOVENSKI STANDARD
SIST EN ISO 16628:2022
01-september-2022
Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)
Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO
16628:2022)
Ta slovenski standard je istoveten z: EN ISO 16628:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 16628:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16628:2022

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SIST EN ISO 16628:2022


EN ISO 16628
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Anaesthetic and respiratory equipment - Tracheobronchial
tubes (ISO 16628:2022)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Sondes trachéobronchiques (ISO 16628:2022) Tracheobronchialtuben (ISO 16628:2022)
This European Standard was approved by CEN on 11 June 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, Turkey 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 16628:2022 E
worldwide for CEN national Members.

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SIST EN ISO 16628:2022
EN ISO 16628:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 16628:2022
EN ISO 16628:2022 (E)
European foreword
This document (EN ISO 16628:2022) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 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/national committee. 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16628:2022 has been approved by CEN as EN ISO 16628:2022 without any modification.

3

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SIST EN ISO 16628:2022

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SIST EN ISO 16628:2022
INTERNATIONAL ISO
STANDARD 16628
Second edition
2022-06
Anaesthetic and respiratory
equipment — Tracheobronchial tubes
Matériel d’anesthésie et de réa
...

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