EN ISO 5359:2008
(Main)Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
ISO 5359:2008 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;
vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection between systems conveying different gases. These hoses assemblies are intended for use at maximum operating pressures less than 1 400 kPa.
ISO 5359:2008 specifies the allocation of non-interchangeable screw-threaded (NIST) connectors, diameter-index safety system (DISS) connectors and sleeve indexed system (SIS) connectors to medical gases and specifies the dimensions of non-interchangeable screw-threaded (NIST) connectors.
Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO 5359:2008)
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;
- Vakuum.
Es ist insbesondere beabsichtigt, die gasartspezifischen Merkmale sicherzustellen und Querverbindungen zwischen Systemen, die verschiedene Gase transportieren, zu verhindern. Diese Schlauchleitungssysteme sind zur Verwendung bei Drücken kleiner als 1 400 kPa vorgesehen.
1.2 Diese Internationale Norm legt die Zuordnung von NIST-, DISS- und SIS-Verbindungsstücken zu medizinischen Gasen fest. Sie legt außerdem die Maße für nichtverwechselbare Verbindungsstücke mit Schraubgewinde (NIST) fest.
1.3 Diese Internationale Norm legt nicht fest:
- Anforderungen an koaxiale Schläuche für die Zu- und Ableitung von Luft zum Betreiben chirurgischer Werkzeuge;
- Anforderungen an die elektrische Leitfähigkeit.
1.4 Diese Internationale Norm legt keine Verwendungszwecke von Schlauchleitungssystemen fest.
ANMERKUNG Folgendes sind Beispiele für Verwendungszwecke, die in anderen Internationalen Normen angegeben sind:
a) zwischen einer Entnahmestelle und einem medizinischen Gerät (ISO 9170-1, IEC 60601-2-12 [7], IEC 60601-2-13 [8]);
b) zwischen dem fest installierten Rohrleitungssystem und einer Entnahmestelle dieses Systems (ISO 7396-1 [10], ISO 11197 [13]);
c) zwischen einer Entnahmestelle und einer zweiten Entnahmestelle (ISO 7396-1);
d) zwischen einer Notversorgung und einem Notfall- und Wartungseinlass eines Rohrleitungssystems (ISO 10524-1 [12], ISO 7396-1);
e) zwischen einer Notversorgung und einem medizinischen Gerät (ISO 10524-1, ISO 10524-3 [16], IEC 60601-2-12, IEC 60601-2-13).
Flexibles de raccordement à basse pression pour utilisation avec les gaz médicaux (ISO 5359:2008)
L'ISO 5359:2008 spécifie les exigences requises pour les flexibles de raccordement à basse pression destinés à être utilisés avec les gaz médicaux suivants:
oxygène;
oxyde 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;
vide.
Elle est en particulier destinée à garantir la spécificité par rapport au gaz et à empêcher toute interversion entre systèmes transportant des gaz différents. Ces flexibles sont destinés à être utilisés avec des pressions maximales de service inférieures à 1 400 kPa.
L'ISO 5359:2008 spécifie l'affectation des raccords à tête filetée non interchangeables (NIST), des systèmes de sécurité à diamètres indexés (DISS) et des raccords à manchons indexés (SIS) aux gaz médicaux et spécifie les dimensions des raccords à tête filetée non interchangeables (NIST).
Nizkotlačne povezovalne cevi za delo z medicinskimi plini (ISO 5359:2008)
Ta mednarodni standard določa zahteve za nizkotlačne povezovalne cevi za delo z naslednjimi medicinskimi plini: – kisik, – dušikov oksid, – medicinski zrak, – helij, – ogljikov dioksid, – ksenon, – določene mešanice zgoraj naštetih plinov, – s kisikom obogaten zrak, – zrak za pogon kirurških instrumentov, – dušik za pogon kirurških instrumentov, – vakuum. Zlasti je namenjen zagotavljanju specifičnosti plinov in preprečevanju navzkrižne povezave med sistemi z različnimi plini. Te povezovalne cevi so namenjene za uporabo pri največjem delovnem tlaku, ki je nižji od 1400 kPa. Ta mednarodni standard določa razporeditev priključkov (NIST), (DISS), (SIS) na medicinske pline in navaja dimenzije priključkov (NIST) z navojem, ki se ne menjajo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN 739:2000
SIST EN 739:2000/A1:2002
1L]NRWODþQHSRYH]RYDOQHFHYL]DGHOR]PHGLFLQVNLPLSOLQL ,62
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
Niederdruckschlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO
5359:2008)
Flexibles basse pression utilisés dans les systemes de gaz médicaux (ISO 5359:2008)
Ta slovenski standard je istoveten z: EN ISO 5359:2008
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
June 2008
ICS 83.140.40; 11.040.10 Supersedes EN 739:1998
English Version
Low-pressure hose assemblies for use with medical gases (ISO
5359:2008)
Flexibles de raccordement à basse pression pour utilisation Niederdruck-Schlauchleitungssysteme zur Verwendung mit
avec les gaz médicaux (ISO 5359:2008) medizinischen Gasen (ISO 5359:2008)
This European Standard was approved by CEN on 29 May 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5359:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC.4
Foreword
This document (EN ISO 5359:2008) 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 December 2008, and conflicting national standards shall be withdrawn
at the latest by June 2010.
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 739:1998.
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 EC Directive(s).
For relationship with EC Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 5359:2008 has been approved by CEN as a EN ISO 5359:2008 without any modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International 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 Medical devices.
Once this standard is cited in the Official Journal of the European Communities 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.
Table ZA.1— Correspondence between this International Standard and
Directive 93/42/EEC Medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4 1
4.1 2.6
4.2 2
4.3.1 7.1, 7.3, 9.3
4.3.2 4, 7.1, 9.2
4.3.3 3, 5, 7.2
4.4.2 9.1, 9.2, 12.7.1
4.4.3 9.2
4.4.4 12.7.1, 12.8.1
4.4.7 9.1, 12.7.4
4.4.8 9.1, 12.7.4
4.4.9 9.1, 12.7.4
4.4.13 7.5
4.4.14 9.1
4.5.1 7.2, 9.3
4.5.2 9.3
5.2 9.1
5.3 7.5
5.4 9.1, 12.7.4
5.5 9.1, 9.2, 12.7.1
5.6 9.2
5.7 12.7.1, 12.8.1
5.8 13.2
6.1 13.2
6.1.3 13.1, 13.3 a), 13.3 d), 13.5
6.1.5 13.3 e)
6.2 13.2
6.3.1 5, 7.2, 7.6
6.3.2 13.1, 13.3 b)
7 2, 13.1, 13.3 a), 13.4, 13.6 d)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 5359
Third edition
2008-06-15
Low-pressure hose assemblies for use
with medical gases
Flexibles de raccordement à basse pression pour utilisation avec les
gaz médicaux
Reference number
ISO 5359:2008(E)
©
ISO 2008
ISO 5359:2008(E)
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ISO 5359:2008(E)
Contents Page
Foreword. v
Introduction . vi
0.1 General. vi
0.2 Standardization of screw-threaded connectors for use in hose assemblies. vi
1 Scope. 1
2 Normative references. 2
3 Terms and definitions. 2
4 General requirements. 5
4.1 Safety. 5
4.2 * Alternative construction. 6
4.3 Materials. 6
4.4 Design requirements . 6
4.4.1 Hose internal diameter . 6
4.4.2 Mechanical strength. 6
4.4.3 Deformation under pressure . 7
4.4.4 Resistance to occlusion. 7
4.4.5 Adhesion strength . 7
4.4.6 Flexibility. 7
4.4.7 Gas-specificity. 7
4.4.8 End connectors. 8
4.4.9 Design of NIST connectors. 8
4.4.10 Design of DISS connectors. 8
4.4.11 Design of SIS connectors . 16
4.4.12 Joining hoses to hose inserts . 16
4.4.13 Leakage. 17
4.4.14 * Pressure drop . 17
4.4.15 Expulsion of nipple. 17
4.5 Constructional requirements. 17
4.5.1 * Cleaning . 17
4.5.2 * Lubricants . 18
5 Test methods. 18
5.1 General. 18
5.1.1 Ambient conditions . 18
5.1.2 Test gas. 18
5.1.3 Reference conditions . 18
5.2 Test method for pressure drop . 18
5.3 Test method for leakage . 18
5.3.1 For all hose assemblies . 18
5.3.2 For hose assemblies fitted with a hose assembly check valve. 18
5.4 Test method for gas-specificity. 18
5.
...
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