EN ISO 21969:2009

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

ISO 21969:2009 applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases:
oxygen;
nitrous oxide;
air for breathing;
helium;
carbon dioxide;
xenon;
mixtures of the gases listed above;
air for driving surgical tools;
nitrogen for driving surgical tools;
oxygen-enriched air.
ISO 21969:2009 applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1.
ISO 21969:2009 applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1.

Flexible Hochdruck-Verbindungen zur Verwendung in Systemen für medizinische Gase (ISO 21969:2009)

Raccords flexibles haute pression pour utilisation avec les systèmes de gaz médicaux (ISO 21969:2009)

L'ISO 21969:2009 s'applique aux raccords flexibles haute pression destinés à être connectés à des bouteilles ou à des cadres de bouteilles dont la pression nominale de remplissage est inférieure ou égale à 25 000 kPa à 15 °C, pour utilisation avec les gaz médicaux suivants:
oxygène;
protoxyde d'azote;
air respirable;
hélium;
dioxyde de carbone;
xénon;
mélanges des gaz énumérés ci-dessus;
air moteur pour appareils chirurgicaux;
azote moteur pour appareils chirurgicaux;
air enrichi d'oxygène.
L'ISO 21969:2009 s'applique aux raccords flexibles haute pression destinés à être utilisés pour connecter des bouteilles ou des cadres de bouteilles aux rampes des sources d'alimentation des réseaux de distribution de gaz médicaux conformes à l'ISO 7396-1.
L'ISO 21969:2009 s'applique aux raccords flexibles haute pression destinés à être utilisés pour connecter une bouteille à l'orifice d'entrée d'un équipement médical (par exemple systèmes d'anesthésie ou ventilateurs pulmonaires) équipé d'un détendeur intégré conforme à l'ISO 10524-1.

Visokotlačni prilagodljivi priključki za uporabo medicinskih plinskih sistemov (ISO 21969:2009)

Ta mednarodni standard velja za visokotlačne prilagodljive priključke, ki se povežejo z jeklenkami ali svežnji jeklenk z nominalnim polnilnim tlakom do 25.000 kPa pri 15°C in se uporabljajo z naslednjimi medicinskimi plini: - kisikom; - dušikovim oksidom; - zrakom za dihanje; - helijem; - ogljikovim dioksidom; - ksenonom; - mešanico zgoraj navedenih plinov; - zrakom za pogon kirurških orodij; - dušikom za pogon kirurških orodij; - s kisikom obogatenim zrakom. Ta mednarodni standard velja za visokotlačne prilagodljive priključke, ki povezujejo jeklenke ali svežnje jeklenk z razdelilniki znotraj cevovodnih sistemov za oskrbo z medicinskimi plini in so v skladu s standardom ISO 7396-1. Ta mednarodni standard velja za visokotlačne prilagodljive priključke, ki povezujejo jeklenke s sesalnim kanalom medicinske opreme (npr. anestezijsko delovno postajo ali pljučnim ventilatorjem), opremljene z vgrajenim regulatorjem tlaka, ki je v skladu s standardom ISO 10524-1. Ta mednarodni standard ne velja za visokotlačne prilagodljive priključke, ki se uporabljajo za polnjenje jeklenk, ali za nizkotlačne prilagodljive sklope cevk, vključene v standard ISO 5359.

General Information

• Status: Published
• Publication Date: 31-Oct-2009
• Withdrawal Date: 30-May-2010
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Nov-2009
• Completion Date: 01-Nov-2009
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 21969:2010 - High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

Relations

• Replaces: EN ISO 21969:2006 - High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21969:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 21969:2006
9LVRNRWODþQLSULODJRGOMLYLSULNOMXþNL]DXSRUDERPHGLFLQVNLKSOLQVNLKVLVWHPRY,62

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
Flexible Hochdruck-Verbindungen zur Verwendung in Systemen für medizinische Gase
(ISO 21969:2009)
Raccords flexibles haute pression pour utilisation avec les systèmes de gaz médicaux
(ISO 21969:2009)
Ta slovenski standard je istoveten z: EN ISO 21969:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 21969:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21969:2010

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SIST EN ISO 21969:2010


EUROPEAN STANDARD
EN ISO 21969

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2009
ICS 11.040.10 Supersedes EN ISO 21969:2006
English Version
High-pressure flexible connections for use with medical gas
systems (ISO 21969:2009)
Raccords flexibles haute pression pour utilisation avec les Flexible Hochdruck-Verbindungen zur Verwendung in
systèmes de gaz médicaux (ISO 21969:2009) Systemen für medizinische Gase (ISO 21969:2009)
This European Standard was approved by CEN on 8 September 2009.

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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21969:2009: E
worldwide for CEN national Members.

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SIST EN ISO 21969:2010
EN ISO 21969:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 21969:2010
EN ISO 21969:2009 (E)
Foreword
This document (EN ISO 21969:2009) 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 May 2010, and conflicting national standards shall be withdrawn at the
latest by May 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 ISO 21969:2006.
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.
For relationship with EU 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 21969:2009 h
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