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EN ISO 23368:2022

(Main)

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.

Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO 23368:2022)

Dieses Dokument legt Anforderungen an Nasenbrillen fest, die sowohl in der häuslichen Pflege als auch in Krankenhausumgebungen für die Sauerstofftherapie verwendet werden.
Dieses Dokument enthält keine Anforderungen zur Verhinderung der Ausbreitung von Feuer in den Schläuchen, definiert jedoch ein vom Benutzer lösbares Verbindungsstück, das zum Einbau einer feueraktivierten Sauerstofffluss-Stoppvorrichtung verwendet werden kann.

Matériel d'anesthésie et d'assistance respiratoire - Canules nasales à faible débit pour oxygénothérapie (ISO 23368:2022)

Le présent document spécifie les exigences applicables aux canules nasales à faible débit utilisées dans les environnements de soins à domicile et dans les environnements hospitaliers pour l’oxygénothérapie.
Le présent document n’inclut pas d’exigences de prévention de la propagation de l’incendie dans la tubulure mais spécifie un raccordement détachable par l’utilisateur qui peut être utilisé pour fixer un dispositif de coupure de l’oxygène activé par un incendie.

Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO 23368:2022)

Ta standard za naprave določa zahteve za nosni kateter, ki se uporablja za izvajanje kisikove terapije pri oskrbi na domu in v bolnišnicah.

General Information

Status
Published
Publication Date
30-Aug-2022
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
31-Aug-2022
Completion Date
31-Aug-2022
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 23368:2022 - Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23368:2022
01-november-2022
Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO
23368:2022)
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy
(ISO 23368:2022)
Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO 23368:2022)
Matériel d'anesthésie et d'assistance respiratoire - Canules nasales à faible débit pour
oxygénothérapie (ISO 23368:2022)
Ta slovenski standard je istoveten z: EN ISO 23368:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 23368:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23368:2022

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SIST EN ISO 23368:2022


EN ISO 23368
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Anaesthetic and respiratory equipment - Low-flow nasal
cannulae for oxygen therapy (ISO 23368:2022)
Matériel d'anesthésie et d'assistance respiratoire - Anästhesie- und Beatmungsgeräte - Nasenbrillen für
Canules nasales à faible débit pour oxygénothérapie die Atemtherapie (ISO 23368:2022)
(ISO 23368:2022)
This European Standard was approved by CEN on 9 July 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 23368:2022 E
worldwide for CEN national Members.

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SIST EN ISO 23368:2022
EN ISO 23368:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 23368:2022
EN ISO 23368:2022 (E)
European foreword
This document (EN ISO 23368:2022) 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 February 2023, and conflicting national standards
shall be withdrawn at the latest by February 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23368:2022 has been approved by CEN as EN ISO 23368:2022 without any modification.


3

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SIST EN ISO 23368:2022

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SIST EN ISO 23368:2022
INTERNATIONAL ISO
...

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