SIST EN ISO 21969:2010
(Main)High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
This International Standard 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. This International Standard 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. This International Standard 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. This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359.
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
Relations
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 has been approved by CEN as a EN ISO 21969:2009 without any modification.
3
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SIST EN ISO 21969:2010
EN ISO 21969:2009 (E)
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 a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
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)/sub-clause(s) of this Essential Requirements (ERs) of Directive
Qualifying remarks/Notes (s) of
International Standard
93/42/EEC9/EC
remarks/Notes
5 1, 2, 3, 4, 5
5.1 7.1, 7.2, 7.3, 9.3
5.3.1 7.1, 7.3, 9.3 -
5.3.2 7.1
5.3.3 3, 4
5.3.4 3, 4, 5
5.4.1 7.5, 7.6, 9.1, 12.7.4
5.4.2 7.5, 7.6, 9.1, 12.7.4
5.4.3 4, 12.7.1
5.4.4 3
5.4.5 7.5, 9.3
5.4.6 4, 9.2, 9.3, 12.7.1
5.4.7 4, 9.2, 9.3, 12.7.1
5.4.8 7.1, 9.3
5.4.9 12.7.1
5.4.10 1, 2, 3
5.5.1 7.1, 9.1, 12.7.1
5.5.2 7.1, 7.2, 7.3, 9.3
6.2.1 7.5
7.1.1 13.1, 13.2
7.1.2 13.3a), 13.6b), 13.3d), 13.5 ER 13.3a) relating to the authorised
representative is not fully addressed
7.2 13.2
7.3.1 3, 5, 7.2, 7.6
7.3.2 13.3b)
8 1, 2, 5, 9.1, 13.1, 13.4, 13.6c),
13.6d),13.3i), 13.3j), 13.3k)
- 13.6q) ER 13.3q) relating to the date of
issue of the last instructions for use is
not addressed
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
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SIST EN ISO 21969:2010
INTERNATIONAL ISO
STANDARD 21969
Second edition
2009-11-01
High-pressure flexible connections
for use with medical gas systems
Raccords flexibles haute pression pour utilisation avec les systèmes
de gaz médicaux
Reference number
ISO 21969:2009(E)
©
ISO 2009
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
Contents Page
Foreword .iv
1 Scope.1
2 * Normative references .2
3 Terms and definitions .2
4 Terminology .3
5 General requirements .4
5.1 Safety.4
5.2 Alternative construction .4
5.3 Materials .4
5.4 Design requirements.4
5.5 Constructional requirements .6
6 Test methods .6
6.1 General .6
6.2 Type tests.7
7 Marking, colour coding and packaging.9
7.1 Marking.9
7.2 Colour coding .10
7.3 Packaging.10
8 Information to be supplied by the manufacturer .10
Annex A (informative) Rationale.12
Bibliography.13
© ISO 2009 – All rights reserved iii
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21969 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 21969:2005) which has been technically
revised.
Annex A contains rationale statements for some of the requirements of this International Standard. It is
included to provide additional insight into the reasoning that led to the requirements and recommendations
that have been incorporated in this International Standard. The clauses and subclauses marked with an
asterisk (*) after their number have corresponding rationale contained in Annex A. It is considered that
knowledge of the reasons for the requirements will not only facilitate the proper application of this International
Standard, but will also expedite any subsequent revision.
iv © ISO 2009 – All rights reserved
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SIST EN ISO 21969:2010
INTERNATIONAL STANDARD ISO 21969:2009(E)
High-pressure flexible connections for use with medical gas
systems
1 Scope
1.1 This International Standard 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.
1.2 This International Standard 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.
1.3 This International Standard 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.
1.4 This International Standard does not apply to high-pressure flexible connections intended to be used to
fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359.
© ISO 2009 – All rights reserved 1
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
2 * Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 407:2004, Small medical gas cylinders — Pin-index yoke-type valve connections
ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document the following terms and definitions apply.
3.1
cylinder bundle
pack or pallet of cylinders linked together with one or more connectors for filling and emptying
3.2
gas-specific
having characteristics which prevent connection between different gas services
3.3
manifold
device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same gas to the pipeline
system
3.4
medical gas
any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnostic or
prophylactic purposes
3.5
nominal inlet pressure
P
1
pressure for which the high-pressure flexible connection is intended to be used
NOTE P is specified by the manufacturer.
1
3.6
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
NOTE This definition was taken from IEC 60601-1.
2 © ISO 2009 – All rights reserved
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
4 Terminology
Typical examples of high-pressure flexible connections are given in Figure 1.
a) Coiled metal pipe (e.g. copper) b) Metal (e.g. copper or stainless steel)
pipe connected by a swivel
c) Corrugated metal (e.g. stainless steel) hose fitted with retaining straps
Key
1 inlet connector
2 outlet connector
3 swivel
4 restraining cable
5 handle to prevent torsion
Figure 1 — Typical examples of high-pressure flexible connections
© ISO 2009 – All rights reserved 3
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SIST EN ISO 21969:2010
ISO 21969:2009(E)
5 General requirements
5.1 Safety
High-pressure flexible connections shall, when transported, stored, installed, operated in normal use and
maintained according to the instructions of the manufacturer, present no risks that are not reduced to an
acceptable level using risk management procedures in accordance with ISO 14971 and which are connected
with their intended application, in normal condition and in single fault condition.
5.2 Alternative construction
High-pressure flexible connections and components or parts thereof, using mat
...
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