EN ISO 10524-3:2019

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2019)

Dieses Dokument legt die Anforderungen an die Ausführung, die Typprüfung und die Kennzeichnung von Flaschenventilen mit integrierten DRUCKMINDERERN [wie in 3.26 definiert und im weiteren Verlauf als VENTILE MIT INTEGRIERTEM DRUCKMINDERER (VIPR) bezeichnet] fest, die für die Verabreichung medizinischer Gase bei der Behandlung, Führung, diagnostischen Beurteilung und Pflege von Patienten oder für Gase zum Betrieb chirurgischer Instrumente vorgesehen sind.
Beispiele für Gase umfassen Sauerstoff, medizinische Luft und Sauerstoff-/Distickstoffoxid-Gemische.
Dieses Dokument gilt für VIPR an nachfüllbaren Gasflaschen mit einem BETRIEBSDRUCK von bis zu 30 000 kPa (300 bar) für die Befüllung in Gasflaschenfülleinrichtungen oder Selbstfülleinrichtungen in der ambulanten Pflege.
In diesem Dokument behandelte VIPR sind hinsichtlich des Drucks voreingestellt und mit einem DRUCKAUSGANG und/oder mit einem oder mehreren voreingestellten DURCHFLUSSAUSGANG/DURCHFLUSSAUSGÄNGEN ausgestattet

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz (VIPR) (ISO 10524-3:2019)

Le présent document spécifie la conception, les essais de type et les exigences de marquage s'appliquant aux détendeurs intégrés dans les robinets de bouteilles [tels que définis en 3.26 et dénommés ci-après détendeur intégré dans les robinets de bouteilles (VIPR)], destinés à l'administration de gaz médicaux dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et des soins portés aux patients, ou de gaz destinés aux instruments chirurgicaux.
Ces gaz sont par exemple l'oxygène, l'air médical et les mélanges d'oxygène et de protoxyde d'azote.
Le présent document s'applique aux VIPR montés sur des bouteilles rechargeables de pression de service inférieure ou égale à 30 000 kPa (300 bar) destinés à être remplis dans des centres de remplissage de bouteilles ou avec des systèmes de remplissage autonomes utilisés dans les applications de soins à domicile.
Les VIPR couverts par le présent document ont une pression préréglée et comportent une (des) sortie(s) en débit préréglée(s) et/ou une sortie en pression.

Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu cilindričnih ventilov jeklenk (ISO 10524-3:2019)

Ta dokument določa projektiranje, tipsko preskušanje in zahteve za označevanje cilindričnih ventilov jeklenk z vgrajenimi tlačnimi regulatorji (kot so določeni v točki 3.26 in v nadaljevanju imenovani ventili z vgrajenimi tlačnimi regulatorji (VIPR)), namenjenih za dovajanje medicinskih plinov pri zdravljenju, upravljanju, diagnostičnem vrednotenju in oskrbi bolnikov, ali za pline, ki omogočajo uporabo kirurških instrumentov.
Primeri plinov: kisik, medicinski zrak in mešanice kisika/dušikovega oksida.
Ta dokument se uporablja za ventile z vgrajenimi tlačnimi regulatorji, nameščene na jeklenke, ki jih je mogoče polniti, z delovnim tlakom do 30.000 kPa (300 barov), namenjene za polnjenje v obratih za polnjenje jeklenk ali v samopolnilnih sistemih, ki se uporabljajo v sistemih za oskrbo na domu.
Ventili za vgrajenimi tlačnimi regulatorji, zajeti v tem dokumentu, imajo predhodno nastavljen tlak in so dobavljeni s tlačno izhodno odprtino in/ali eno ali več odprtinami s predhodno nastavljenim pretokom.

General Information

• Status: Published
• Publication Date: 29-Jan-2019
• Withdrawal Date: 30-Jul-2019
• 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: 30-Jan-2019
• Completion Date: 30-Jan-2019
• 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 10524-3:2019 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)

Relations

• Replaces: EN ISO 10524-3:2006 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
• Effective Date: 06-Feb-2019
• Replaces: EN ISO 10524-3:2006/A1:2013 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)
• Effective Date: 01-Mar-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-3:2006
SIST EN ISO 10524-3:2006/A1:2013
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYVNORSX
FLOLQGULþQLKYHQWLORYMHNOHQN,62
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (VIPRs) (ISO 10524-3:2019)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (VIPR) (ISO 10524-3:2019)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10524-3
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-3:2006
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves
(VIPRs) (ISO 10524-3:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Druckminderer zur Verwendung mit medizinischen
Partie 3: Détendeurs intégrés dans les robinets des Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO
bouteilles de gaz (VIPR) (ISO 10524-3:2019) 10524-3:2019)
This European Standard was approved by CEN on 3 October 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-3:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10524-3:2019) 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 July 2019, and conflicting national standards shall be
withdrawn at the latest by July 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10524-3:2006.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10524-3:2019 has been approved by CEN as EN ISO 10524-3:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 10524-3
Second edition
2019-01
Pressure regulators for use with
medical gases —
Part 3:
Pressure regulators integrated with
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à gaz
(VIPR)
Reference number
ISO 10524-3:2019(E)
©
ISO 2019
ISO 10524-3:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
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Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 10524-3:2019(E)
Contents Page
Foreword .vi
Introduction .viii
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 4
5 General requirements . 5
5.1 Safety . 5
5.2 Usability . 5
5.3 Materials . 5
5.4 Alternative construction . 6
6 Design requirements . 6
6.1 *General . 6
6.2 Integrated electronic device . 7
6.3 Filling port . 7
6.4 Connections . 8
6.4.1 valve inlet connection . 8
6.4.2 Outlet connectors . 8
6.5 *Requirements for outlet pressure . 8
6.5.1 Pressure outlet . 8
6.5.2 Flow outlet . 9
6.6 Cylinder pressure or cylinder content indicator . 9
6.6.1 Pressure gauges and cylinder content indicators . 9
6.7 Flow selector .10
6.8 Filtration .10
6.9 Main shut-off .10
6.10 Residual pressure device .10
6.11 *Pressure-relief device .10
6.12 Leakage .11
6.13 Mechanical strength .11
6.13.1 Resistance of the high-pressure side .11
6.13.2 Resistance of the low-pressure side to excessive pressure .12
6.13.3 Resistance of the low-pressure side to P .12
6.13.4 Impact and drop tests .12
6.14 *Resistance to ignition .12
6.15 Requirements for VIPR fitted with fixed orifices .12
6.15.1 Stability and accuracy of flow .12
6.15.2 *Flow setting torque .13
6.15.3 Removal of a fixed orifice .13
6.15.4 Legibility .13
6.16 Endurance .13
6.16.1 flow selector .13
6.16.2 Non-return valve fitted to the filling port .13
6.16.3 Pressure regulator .13
7 Construction requirements .
...