EN ISO 5359:2014
(Main)Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)
ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO 5359:2014)
1.1 Diese Internationale Norm legt die Anforderungen an Niederdruck-Schlauchleitungssysteme fest, die zur Verwendung mit den folgenden medizinischen Gasen vorgesehen sind:
- Sauerstoff;
- Lachgas;
- medizinische Luft;
- Helium;
- Kohlendioxid;
- Xenon;
- spezifizierte Gemische der oben genannten Gase;
- mit Sauerstoff angereicherte Luft;
- Luft zum Betreiben chirurgischer Werkzeuge;
- Stickstoff zum Betreiben chirurgischer Werkzeuge;
und zur Verwendung mit Vakuum.
1.2 * Sie gilt für Schlauchleitungssysteme zur Verwendung bei Drücken bis 1 400 kPa und für Vakuumsysteme, bei denen der Druck 60 kPa absolut nicht übersteigt.
1.3 Diese Internationale Norm legt nicht die Maße und die Zuordnung von gasartspezifischen Eingangs-und Ausgangsverbindungstücken für die Schlauchsysteme fest.
ANMERKUNG 1 Festlegungen für die Maße und die Zuordnung von durchmessercodierten Sicherheitssystemen (DISS) sind in CGA V-5 [28] enthalten.
ANMERKUNG 2 Festlegungen für die Maße und die Zuordnung von hülsencodierten Systemen (SIS) sind in AS 2896 [23] enthalten.
ANMERKUNG 3 Die Maße und die Zuordnung von nichtverwechselbaren Verbindungsstücken mit Schraubgewinde (NIST) sind in ISO 18082 festgelegt.
ANMERKUNG 4 Entnahmestellen für Schnellverbindungsstücke sind in ISO 9170-1 festgelegt.
1.4 Diese Internationale Norm legt keine Anforderungen an koaxiale Schläuche für die Zu- und Ableitung von Luft zum Betreiben chirurgischer Werkzeuge fest.
1.5 Diese Internationale Norm legt nicht den Verwendungszweck von Schlauchleitungssystemen fest.
ANMERKUNG Umweltaspekte werden in Anhang B behandelt.
Matériel d'anesthésie et de réanimation respiratoire - Flexibles de raccordement à basse pression pour utilisation avec les gaz médicaux (ISO 5359:2014)
L'ISO 5359:2014 spécifie les exigences relatives aux flexibles de raccordement à basse pression destinés à être utilisés avec les gaz médicaux suivants: oxygène, protoxyde d'azote, air médical, hélium, dioxyde de carbone, xénon, mélanges spécifiés des gaz précités, air enrichi en oxygène, air pour les instruments chirurgicaux, azote pour les instruments chirurgicaux et pour une utilisation avec le vide. Elle s'applique aux flexibles fonctionnant à des pressions allant jusqu'à 1 400 kPa et, pour les systèmes de vide, à des pressions absolues inférieures à 60 kPa. Elle ne spécifie pas les dimensions et l'affectation des raccords d'entrée et de sortie spécifiques à un gaz pour les flexibles.
Anestezijska in dihalna oprema - Nizkotlačne povezovalne cevi za delo z medicinskimi plini (ISO 5359:2014)
1.1 Ta mednarodni standard določa zahteve za nizkotlačne povezovalne cevi za
delo z naslednjimi medicinskimi plini:
– kisikom,
– dušikovim oksidom,
– medicinskim zrakom,
– helijem,
– ogljikovim dioksidom,
– ksenonom,
– določeno mešanico zgoraj navedenih plinov,
– s kisikom obogatenim zrakom,
– zrakom za pogon kirurških instrumentov,
– dušikom za pogon kirurških instrumentov
in za uporabo v vakuumu.
1.2 *Uporablja se za povezovalne cevi, ki delujejo pod tlakom do 1400 kPa, in za vakuumske sisteme pod
tlakom, ki ne presega absolutnega tlaka 60 kPa.
1.3 Ta mednarodni standard ne določa mer in dodelitve za plin namenjenih vhodnih
in izhodnih priključkov za povezovalne cevi.
OPOMBA 1: Specifikacije za mere in dodelitev priključkov sistemov z različnimi premeri spojk (DISS) so opredeljene v CGA V-5 [28].
OPOMBA 2: Specifikacije za mere in dodelitev priključkov sistemov ovojev (SIS) so opredeljene v AS 2896 [23].
OPOMBA 3: Mere in dodelitev priključkov z navojem, ki se ne menjajo (NIST), so opredeljene v ISO 18082 [11].
OPOMBA 4: Končni deli za hitre priključke so opredeljeni v ISO 9170-1.
1.4 Ta mednarodni standard ne določa zahtev za koaksialne cevi, ki se uporabljajo za dotok
in odtok zraka za poganjanje kirurških instrumentov.
1.5 Ta mednarodni standard ne določa predvidenih uporab povezovalnih cevi.
OPOMBA: Okoljski vidiki so obravnavani v dodatku B.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 5359:2008
SIST EN ISO 5359:2008/A1:2012
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Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases (ISO 5359:2014)
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur
Verwendung mit medizinischen Gasen (ISO 5359:2014)
Matériel d'anesthésie et de réanimation respiratoire - Flexibles de raccordement à basse
pression pour utilisation avec les gaz médicaux (ISO 5359:2014)
Ta slovenski standard je istoveten z: EN ISO 5359:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 5359
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.10; 83.140.40 Supersedes EN ISO 5359:2008
English Version
Anaesthetic and respiratory equipment - Low-pressure hose
assemblies for use with medical gases (ISO 5359:2014)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Niederdruck-
Flexibles de raccordement à basse pression pour utilisation Schlauchleitungssysteme zur Verwendung mit
avec les gaz médicaux (ISO 5359:2014) medizinischen Gasen (ISO 5359:2014)
This European Standard was approved by CEN on 24 August 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 5359:2014 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 5359:2014) 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 ISO 5359:2008.
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 5359:2014 has been approved by CEN as EN ISO 5359:2014 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 a means to conforming to Essential Requirements of the New Approach
Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the Member States
concerning medical devices” (Medical Device Directive).
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 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.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/subclause(s) of this Corresponding essential Qualifying remarks/notes
International Standard requirements of
Directive 93/42/EEC
4.5.3, 4.7.1, 6.3.1 7.2
4.5.1, 4.7.2 7.3
4.5.2, 6.1.6, 7.3, 2nd dash 7.5 partially covered for phthalates;
provision of rationale for using
phthalates with the information to be
provided not required
6.3.1 7.6
4.6.2.1, 4.6.7, 4.6.8, 4.6.9, 4.6.10, 9.1
4.6.11
4.5.2, 4.5.4, 4.6.2, 4.6.3, 4.6.5 9.2, first and second second indent covered for temperature
indents only and pressure
4.5.1, 4.7.1, 4.7.2 9.3 and via normative reference to
ISO 15001
4.6.2, 4.6.3, 4.6.4, 4.6.5 12.7.1
4.6.7, 4.6.8, 4.6.9 12.7.4
4.6.4 12.8.1
6.1, 6.2, 7 13.1
6.2 13.2 only gas-specific colour coding is
addressed.
6.1.2, 6.1.3, 7.2, 2nd dash 13.3 a) only covered if the name and address
of the authorized representative is
placed on the label, if applicable
6.3.2 13.3 b)
6.1.5 13.3 e)
7.3 first dash, 7.4 13.6 d) installation is not applicable
7.3 first dash 13.6 i)
7.3, last dash 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 products falling within the scope of this
International Standard.
INTERNATIONAL ISO
STANDARD 5359
Fourth edition
2014-10-01
Anaesthetic and respiratory
equipment — Low-pressure hose
assemblies for use with medical gases
Matériel d’anesthésie et de réanimation respiratoire — Flexibles de
raccordement à basse pression pour utilisation avec les gaz médicaux
Reference number
ISO 5359:2014(E)
©
ISO 2014
ISO 5359:2014(E)
© ISO 2014
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ISO 5359:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 6
4.1 Risk management . 6
4.2 Usability . 6
4.3 Clinical investigation . 6
4.4 Safety . 6
4.5 Materials . 7
4.6 Design requirements . 7
4.7 Constructional requirements .10
5 Test methods .11
5.1 General .11
5.2 Test method for pressure drop .11
5.3 Test method for leakage .11
5.4 Test method for gas specificity .11
5.5 Test method for mechanical strength .11
5.6 Test method for deformation under pressure .12
5.7 Test method for resistance to occlusion .12
5.8 Test method for durability of markings and colour coding .13
6 Marking, colour coding and packaging .13
6.1 Marking .13
6.2 Colour coding .14
6.3 Packaging .15
7 Information to be supplied by the manufacturer .
...
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