EN ISO 23372:2022
(Main)Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs.
This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration.
This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
Anästhesie- und Beatmungsgeräte - Luftbeimischgeräte (ISO 23372:2022)
Dieses Dokument legt Mindestanforderungen an die Leistungsfähigkeit und Sicherheit von Luftbeimischgeräten fest, die für die Abgabe festgelegter Sauerstoffkonzentrationen an Patienten verwendet werden. Es bietet ein Prüfverfahren zur Überprüfung der Genauigkeit der Sauerstoffkonzentration im Luft-Sauerstoff-Gemisch, das durch das Luftbeimischgerät erzeugt wird. Luftbeimischgeräte können so eingestellt sein, dass sie nur eine Sauerstoffkonzentration bereitstellen oder einstellbar sein, um einen Bereich von Sauerstoffkonzentrationen abzugeben.
Dieses Dokument legt auch Anforderungen an die Kennzeichnung fest und enthält Empfehlungen an ein wahlweises Farbcodierungssystem, das den Anwender bei der Identifizierung der bestimmten Sauerstoffkonzentration unterstützt.
Dieses Dokument behandelt keine Luftbeimischgeräte, die ein integraler Teil von medizinischen Geräten sind, für die in anderen Normen Festlegungen bestehen (z. B. Beatmungsgeräte für den Notfall, Anfeuchter, Vernebler).
Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’entraînement d’air(ISO 23372:2022)
Le présent document spécifie les exigences de sécurité et de performance minimales des dispositifs d’entraînement d’air utilisés pour administrer des concentrations en oxygène désignées aux patients. Il fournit une méthode d’essai permettant de vérifier la précision de la concentration en oxygène dans le mélange air/oxygène généré par les dispositifs d’entraînement d’air. Les dispositifs d’entraînement d’air peuvent être réglés pour administrer une seule concentration en oxygène ou une gamme de concentrations en oxygène.
Le présent document spécifie également des exigences de marquage et recommande un système optionnel de code couleurs pour aider l’utilisateur à identifier la concentration en oxygène désignée.
Le présent document ne traite pas des dispositifs d’entraînement d’air qui sont intégrés à des dispositifs médicaux spécifiés dans d’autres normes (par exemple les ventilateurs pulmonaires d’urgence, les humidificateurs, les nébuliseurs).
Anestezijska in dihalna oprema - Vhodne naprave za zrak (ISO 23372:2022)
Ta dokument določa minimalne zahteve glede učinkovitosti in varnosti vhodnih naprav za zrak, ki se uporabljajo za dovajanje predvidenih koncentracij kisika bolnikom. Vsebuje preskusno metodo za preverjanje točnosti koncentracije kisika v mešanici zraka in kisika, ki jo pripravijo vhodne naprave za zrak. Vhodne naprave za zrak so lahko fiksno nastavljene za dovajanje ene same koncentracije kisika ali nastavljive, tako
da dovajajo različne izhodne koncentracije kisika.
Ta dokument določa tudi zahteve za označevanje ter priporočljiv izbirni sistem barvnega kodiranja za pomoč uporabniku pri določanju predvidene koncentracije kisika.
Ta dokument ne obravnava vhodnih naprav za zrak, ki so sestavni del medicinskih pripomočkov, določenih v drugih standardih (npr. pljučni ventilatorji za nujne primere, vlažilniki, nebulatorji).
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23372:2022
01-julij-2022
Nadomešča:
SIST EN 13544-3:2002+A1:2009
Anestezijska in dihalna oprema - Vhodne naprave za zrak (ISO 23372:2022)
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
Atemtherapiegeräte - Luftbeimischgeräte (ISO 23372:2022)
Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’entraînement d’air
(ISO 23372:2022)
Ta slovenski standard je istoveten z: EN ISO 23372:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 23372:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23372:2022
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SIST EN ISO 23372:2022
EN ISO 23372
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 13544-3:2001+A1:2009
English Version
Anaesthetic and respiratory equipment - Air entrainment
devices (ISO 23372:2022)
Matériel d'anesthésie et de réanimation respiratoire - Atemtherapiegeräte - Luftbeimischgeräte (ISO
Dispositifs d'entraînement d'air(ISO 23372:2022) 23372:2022)
This European Standard was approved by CEN on 7 February 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 23372:2022 E
worldwide for CEN national Members.
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SIST EN ISO 23372:2022
EN ISO 23372:2022 (E)
Contents Page
European foreword . 3
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SIST EN ISO 23372:2022
EN ISO 23372:2022 (E)
European foreword
This document (EN ISO 23372:2022) 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
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.
This document supersedes EN 13544-3:2001+A1:2009.
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 23372:2022 has been approved by CEN as EN ISO 23372:2022 without any modification.
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SIST EN ISO 23372:2022
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SIST EN ISO 23372:2022
INTERNATIONAL ISO
STANDARD 23372
Firs
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