EN ISO 10524-3:2006
(Main)Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
ISO 10524-3:2005 applies to pressure regulators integrated with cylinder valves intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases:
oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools.
These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and measure the flow of the medical gas delivered.
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2005)
1.1 Dieser Teil von ISO 10524 gilt für Druckminderer in Flaschenventilen (wie in 3.16 definiert), die für die Verabreichung medizinischer Gase bei der Behandlung, Führung, diagnostischen Beurteilung und Pflege von Patienten zur Verwendung mit folgenden medizinischen Gasen vorgesehen sind:
- Sauerstoff;
- Distickstoffoxid;
- Luft für Beatmungszwecke;
- Helium;
- Kohlendioxid;
- Xenon;
- festgelegte Gemische der oben genannten Gase;
- Luft zum Antrieb chirurgischer Werkzeuge;
- Stickstoff zum Antrieb chirurgischer Werkzeuge.
1.2 * Diese Druckminderer in Flaschenventilen sind für den Anschluss an Gasflaschen mit Nennfülldrücken bis zu 25 000 kPa bei 15 °C vorgesehen und können mit Geräten geliefert werden, die den Durchfluss des abgegebenen medizinischen Gases regeln und messen.
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz (ISO 10524-3:2005)
L'ISO 10524-3:2005 s'applique aux détendeurs intégrés dans les robinets de bouteilles, destinés à administrer des gaz médicaux dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et du soin aux patients, et utilisés avec les gaz médicaux suivants:
l'oxygène;
le protoxyde d'azote;
l'air respirable;
l'hélium;
le dioxyde de carbone;
le xénon;
les mélanges spécifiés des gaz mentionnés ci-dessus;
l'air pour les instruments chirurgicaux;
l'azote pour les instruments chirurgicaux.
Ces détendeurs intégrés dans les robinets des bouteilles de gaz sont prévus pour être fixés sur des bouteilles avec des pressions de remplissage nominales atteignant 25 000 kPa à 15 °C et peuvent être équipés de dispositifs permettant de réguler et de mesurer le débit du gaz médical fourni au patient.
Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu ventilov jeklenk (ISO 10524-3:2005)
1.1 Ta del standarda ISO 10524 velja za tlačne regulatorje v sklopu ventilov jeklenk (kot je opredeljeno v točki 3.16), namenjene doziranju medicinskih plinov pri zdravljenju, diagnostičnem ocenjevanju, oskrbi bolnikov in ravnanju z njimi, za naslednje medicinske pline:
– kisik,
– dušikov oksid,
– zrak za dihanje,
– helij,
– ogljikov dioksid,
– ksenon,
– določene zmesi zgoraj navedenih plinov,
– zrak za delovanje kirurških instrumentov,
– dušik za delovanje kirurških instrumentov.
1.2 Ti tlačni regulatorji v sklopu ventilov jeklenk so namenjeni namestitvi v jeklenke z nazivnim polnilnim tlakom do 25000 kPa pri 15 °C in jih je mogoče uporabljati skupaj z napravami, ki nadzorujejo in merijo tok dovajanega medicinskega plina.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN 738-3:2000
SIST EN 738-3:2000/A1:2002
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO 7ODþQLUHJXODWRUMLYVNORSXYHQWLORY
MHNOHQN ,62
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (ISO 10524-3:2005)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (ISO 10524-3:2005)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2006
ICS:
11.040.10
23.060.40
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10524-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.040.10 Supersedes EN 738-3:1998
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves (ISO 10524-
3:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
3: Détendeurs intégrés dans les robinets des bouteilles de Teil 3: Druckminderer in Flaschenventilen (ISO 10524-
gaz (ISO 10524-3:2005) 3:2005)
This European Standard was approved by CEN on 20 March 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-3:2006: 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 Medical Devices.4
Foreword
The text of ISO 10524-3:2005 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
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 October 2006, and conflicting national standards shall be withdrawn at
the latest by October 2006.
This document supersedes EN 738-3:1998.
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 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, 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.
Endorsement notice
The text of ISO 10524-3:2005 has been approved by CEN as EN ISO 10524-3:2006 without any modifications.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical Devices
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 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 clauses of this
standard given in table ZA 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 — Correspondence between this European Standard and Directive 93/42/EEC Medical
devices
Essential requirements (ERs) of EU
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 9.3
5.3.2 4, 7.1, 9.2
5.3.3 3, 5
5.3.4 7.1, 7.2
5.4 2, 3, 4
5.4.1.1 10
5.4.1.3 10.2
5.4.1.4 10.1
5.4.2 9.1, 12.7.4
5.4.3 9.1, 12.7.4
5.4.4 9.1, 12.7.4
5.4.5 12.2
5.4.6 12.8.1
5.4.7 12.8.1
5.4.8 12.7.1
5.4.9 7.2, 7.6
5.4.12 7.5, 9.2, 12.7.1
5.4.13 7.5
5.4.14 9.2
Essential requirements (ERs) of EU
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5.4.15 7.3, 9.3
5.4.16.1 10.3, 12.8.2
5.4.16.2 10.2
5.4.16.3 10.1, 12.8.1, 12.8.2
5.4.16.4 10.1, 12.8.1, 12.8.2
5.4.17.1 12.8.1, 12.8.2
5.4.17.2 10.1, 12.8.1, 12.8.2
5.4.17.3 10.1, 12.8.1, 12.8.2
5.4.18.1 10.1, 12.8.1, 12.8.2
5.4.18.2 10.2
5.5.1 7.2, 9.3
5.5.2 7.3, 9.3
6 3, 7.5, 9.2, 9.3, 12.7.1, 12.8.1, 12.8.2
7.1 13.1, 13.2
7.1.2 a) 13.1, 13.3 a)
7.1.2 b) 13.3 b)
7.1.2 c) 13.3 d), 13.5
7.1.2 d) 9.1, 12.7.4
7.1.4, a) 13.1, 13.3 a)
7.1.5 12.9
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13. 13.3 b)
8.1 13.1, 13.3 a), 13.4, 13.6 a)
8.2 13.6 b)
8.3 13.6 b)
8.5 13.6 c), 13.6 d)
8.6 9.1, 9.3, 13.1, 13.6 c), 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 10524-3
First edition
2005-05-01
Pressure regulators for use with medical
gases —
Part 3:
Pressure regulators integrated with
cylinder valves
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés aux valves des bouteilles de gaz
Reference number
ISO 10524-3:2005(E)
©
ISO 2005
ISO 10524-3:2005(E)
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ISO 10524-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols . 4
5 General requirements . 4
5.1 Safety. 4
5.2 Alternative construction. 4
5.3 Materials. 4
5.4 Design requirements . 5
5.5 Constructional requirements. 12
6 Test methods. 13
6.1 Conditions. 13
6.2 Test methods for outlet pressure. 14
6.3 Test method for pressure-relief valve. 15
6.4 Test methods for leakage. 15
6.5 Test method for mechanical strength. 16
6.6 Test method for resistance to ignition. 17
6.7 Test method for accuracy of flow of pressure regulators integrated with cylinder valves
fitted with flowmeters or flowgauges. 20
6.8 Test method for the stability of flow of pressure regulators integrated with cylinder valves
fitted with flowmeters or flowgauges. 20
6.9 Test method for stability and accuracy of flow of pressure regulators integrated with
cylinder valves fitted with fixed orifices . 20
6.10 Test method for flow setting and loosening torques . 20
6.11 Drop test. 21
6.12 Impact test . 21
6.13 Test method for means of gas shut-off . 22
6.14 Test method for non-return valve of filling port. 22
6.15 Test method for durability of markings and colour coding. 22
7 Marking, colour coding, packaging. 22
7.1 Marking. 22
7.2 Colour coding. 23
7.3 Packaging . 23
8 * Information to be supplied by the manufacturer. 24
Annex A (informative) Examples of pressure regulators integrated with cylinder valves . 26
Annex B (normative) Rationale . 29
Annex C (informative) Reported regiona
...
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