EN ISO 5367:2014

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)

ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions.
ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2014)

* Diese Internationale Norm legt grundlegende Anforderungen für Atemsets und für Atemschläuche fest, die zur Verwendung mit Anästhesie-Atemsystemen, Atemsystemen von Beatmungsgeräten, Anfeuchtern und Verneblern bestimmt sind. Sie gilt für Atemsets und Atemschläuche sowie für Adapter am Patientenende, die entweder bereits konfektioniert oder als Bauteile zum Zusammenbau nach den Anweisungen des Herstellers geliefert werden.
Diese Internationale Norm gilt für Atemsets, die spezielle Bauteile (z. B. Wasserabscheider) zwischen dem Patientenende und dem Maschinenende, die bereits konfektioniert geliefert werden, enthalten.
Diese Internationale Norm gilt nicht für Atemsets und Atemschläuche für spezielle Zwecke.
BEISPIEL 1 Beatmungsgeräte mit speziellen Anforderungen an die Compliance, den Druck oder die Atemfrequenz.
BEISPIEL 2 Hochfrequenzbeatmung (High Frequency Oscillation Ventilation, HFOV) oder Hochfrequenz-Jet-Beatmung, (High Frequenzy Jet Ventilation, HFJV).
BEISPIEL 3 Atemsets und Atemschläuche mit speziellen Verbindungsstücken für die Beatmung von Neugeborenen.
Es wurden Festlegungen für koaxiale und zugehörige Atemsets, die sich gabeln, zweilumig sind oder mehrere Lumen besitzen, getroffen sowie für Atemschläuche, die für den Gebrauch mit Adaptern am Patientenende geeignet sind.
ANMERKUNG 1 Beispiele für verschiedene Arten von Atemsets mit Adaptern am Patientenende sind in Anhang A dargestellt.
Anforderungen an Ausatemventile, Abgasventile, einstellbare Druckbegrenzungsventile (APL-Ventil), Wärme- und Feuchtigkeitsaustauscher (HMEs), Atemfilter und Reservoirbeutel, sofern vorhanden, sind nicht durch diese Internationale Norm abgedeckt.
ANMERKUNG 2 ISO 80601-2-12, ISO 80601-2-13 und ISO 9360-1 [3], ISO 23328-2 [4] und ISO 5362 [1] legen hierfür Anforderungen fest.
ANMERKUNG 3 Bestimmte Aspekte für beheizte Atemschläuche werden in ISO 8185 [2] behandelt.

Matériel d'anesthésie et de réanimation respiratoire - Systèmes respiratoires et raccords (ISO 5367:2014)

L'ISO 5367:2014 spécifie les exigences de base concernant les systèmes respiratoires et les tubes respiratoires destinés à être utilisés avec des systèmes respiratoires d'anesthésie, des systèmes respiratoires de ventilateurs, des humidificateurs ou des nébuliseurs. Elle s'applique aux systèmes respiratoires, tubes respiratoires et adaptateurs d'extrémité «patient» fournis déjà assemblés ainsi qu'à ceux qui sont fournis en tant que composants et assemblés conformément aux instructions du fabricant.
L'ISO 5367:2014 s'applique aux systèmes respiratoires qui incluent des composants spéciaux (par exemple, pièges à eau) entre l'extrémité «patient» et l'extrémité «appareil» qui sont fournis déjà assemblés.
Des dispositions ont été prises pour les systèmes respiratoires et les tubes respiratoires coaxiaux, à double branche, à double ou multiples lumières, destinés à être utilisés avec des adaptateurs d'extrémité «patient».

Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2014)

*Ta mednarodni standard določa osnovne zahteve za dihalne sete in cevke za dihanje, namenjene uporabi s sistemi za vdihavanje anestetika, ventilatorskimi dihalnimi sistemi, vlažilniki ali nebulatorji. Uporablja se za dihalne sete in cevke za dihanje ter priključke za pacienta, ki se dobavijo že sestavljeni, in za tiste, ki se dobavijo kot komponente ter se sestavijo v skladu z navodili proizvajalca.
Ta mednarodni standard se uporablja za dihalne sete, ki vključujejo posebne komponente (npr. sifone) med pacientom in aparatom, dobavljene že sestavljene. Ta mednarodni standard se ne uporablja za dihalne sete in cevke za dihanje za posebne namene. PRIMER 1: Ventilatorji s posebnimi zahtevami glede skladnosti, tlaka ali frekvence dihanja.
PRIMER 2: Visokofrekvenčno oscilacijsko predihavanje (HFOV) ali visokofrekvenčno pospešeno predihavanje (HFJV).
PRIMER 3: Dihalni seti in cevke za dihanje s posebnimi priključki za predihavanje novorojenčkov.
Predpisi so pripravljeni za koaksialne in povezane razcepljene, dvolumenske ali večlumenske dihalne sete in cevke za dihanje za uporabo s priključki za paciente.
OPOMBA 1: Primeri različnih tipov dihalnih setov s priključki za paciente so prikazani v dodatku A. Zahteve za ventile za izdihavanje, izpušne ventile, prilagodljive ventile za omejitev tlaka (APL), izmenjevalnike toplote in vlage (HME), dihalne filtre in zbiralne vrečke, če so zagotovljene, niso del tega mednarodnega standarda.
OPOMBA 2: Le-ti so obravnavani v standardih ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4] in ISO 5362[1]. OPOMBA 3: Nekateri vidiki ogrevanih cevk za dihanje so obravnavani v standardu ISO 8185[2].

General Information

• Status: Withdrawn
• Publication Date: 21-Oct-2014
• Withdrawal Date: 25-Jul-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 5367:2015 - Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)

Relations

• Replaces: EN 12342:1998+A1:2009 - Breathing tubes intended for use with anaesthetic apparatus and ventilators
• Effective Date: 08-Aug-2012
• Replaced By: EN ISO 5367:2023 - Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5367:2015
01-januar-2015
1DGRPHãþD
SIST EN 12342:2000+A1:2009
$QHVWH]LMVNDLQGLKDOQDRSUHPD'LKDOQLVHWLLQSULNOMXþNL,62
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de
connecteurs (ISO 5367:2014)
Ta slovenski standard je istoveten z: EN ISO 5367:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5367:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5367:2015

EUROPEAN STANDARD
EN ISO 5367

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.040.10 Supersedes EN 12342:1998+A1:2009
English Version
Anaesthetic and respiratory equipment - Breathing sets and
connectors (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Systèmes respiratoires et raccords (ISO 5367:2014) Verbindungsstücke (ISO 5367:2014)
This European Standard was approved by CEN on 18 July 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5367:2014 E
worldwide for CEN national Members.

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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Foreword
This document (EN ISO 5367:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by October 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12342:1998+A1:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of I
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