EN ISO 5367:2014
(Main)Anaesthetic and respiratory equipment - Breathing sets and connectors (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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 ISO 5367:2014 has been approved by CEN as EN ISO 5367:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
standard.
Table ZA 1 — Correspondence between this European Document and Directive 93/42/EEC
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
5.1 7.1 (2nd, and 3rd indents)
4.3
5.1.1 7.2 5.1.1 mandates that these devices shall satisfy
the biological safety testing indicated in
7.1
ISO 10993-1
7.2
7.1 and 7.2 covers the integrity of the packaging
only for devices supplied sterile
4.1.1 7.3 first part 4.1.1, 4.1.2, and 5.1 mandates a risk
4.1.2 assessment be carried out which does not
exclude risks associated with materials and the
5.1
substances with which they may come into
contact.
5.1.3, 7.5 Partly addressed by 5.1.3 and 8.3.m) calls
8.3.m) specifically for a warning if phthalates are
incorporated
7.1, 8.1 Partly addressed. 7.1 and 8.3.a) mandate that
sterile devices are clearly marked according to
7.2,
EN 556–1 mandates the requirements of
8.3.a) ISO 11607-1 to ensure that the packaging is
suitable to prevent contamination during
transportation and use.
7.2 8.3 Partly addressed by 7.2 which mandates the
requirements of ISO 11607-1 that the packaging
is suitable to prevent contamination during
transportation and use.
7.1 8.4
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
7.1 8.5
8.3.a) 8.7 Partly covered. Marked sterile if appropriate
5.3 9.1 Generally covered by mandating construction
5.4 and testing of the interface connectors, leakage,
resistance, compliance, resistance to tube
5.5
collapse and kinking.
5.6
5.2 Partly covered to address only the risk of injury
9.2 (first three indents)
in connection with their physical features by
5.3
specifying sizing and marking conventions for
5.4
the ID/OD of the breathing tubes, and leakage,
resistance, and compliance when performance
5.5
tested in accordance with parameters
5.6
associated with a declared patient category.
8.3 c)
8.3 d), e), f), g), m)
8.4.1
8.4.2
8.4.3
8.4.5
5.3.1 12.7.4 Partly addressed for conical gas connectors
only.
5.3.2
5.3.3
5.3.5
5.3.6
8 13.1
8.1
8.2
8.3
8.4
8.1 13.2 Generally covered. Symbols are mandated in
8.1 to conform to EN 1041, ISO 7000 or
ISO 15223-1
8.2 a) 13.3 a)
8.3 i)
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
8.3 c) 13.3 b) Covered for patient category, length, resistance,
total compliance and internal diameter.
8.3 d)
8.3 e) and f)
8.3 g)
8.3 h)
8.3 a) 13.3 c)
8.3 j) 13.3 d)
8.3.k) 13.3 e)
8.3.b) 13.3 f)
8.4.2 13.3 j) Partly addressed with requirements for
instructions for typical components or
8.4.3
processes.
8.4.4
8.4.5
8.3 l) 13.3 k)
8.3 m)
8.3 a) 13.3 m) Partly addressed. Method of sterilization is
addressed only as a recommendation.
8.4.5 13.5 Partly addressed. Limited to detachable
connectors, which are sized in accordance with
ISO 5356-1 instructs users on coaxial integrity
testing
8, 8.1, 8.2, 8.3, 8.4 13.6 , a), b), c)
8.4.4 13.6 h) Partly addressed. Risks associated with the
reuse of devices marked for single use are
8.3 l)
covered partly by the risk management file and
use of the informative Annex F Hazard
identification for risk assessment
8.4.5 13.6 i) Partly addressed. Details for coaxial set user
tests are mandated
8.4.6 13.6 q)
NOTE Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. This means that risks have
to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the
wording of the corresponding essential requirement
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard
INTERNATIONAL ISO
STANDARD 5367
Fifth edition
2014-10-15
Anaesthetic and respiratory
equipment — Breathing sets and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Systèmes
respiratoires et raccords
Reference number
ISO 5367:2014(E)
©
ISO 2014
ISO 5367:2014(E)
© ISO 2014
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ISO 5367:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 4
4.3 Clinical evaluation . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
4.6 Recommended service life . 5
5 Specific requirements . 5
5.1 Materials . 5
5.2 Length . 5
5.3 Means of connection . 6
5.4 Leakage .
...
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