EN ISO 10524-1:2019
(Main)Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)
ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures 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.
ISO 10524-1:2018 applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2018)
Dieses Dokument definiert die Anforderungen an die Ausführung, die Konstruktion, die Typprüfung und die Kennzeichnung von DRUCKMINDERERN (wie in 3.18 definiert), die für die Verabreichung medizinischer Gase und ihrer Gemische bei der Behandlung, Führung, diagnostischen Beurteilung und Pflege von Patienten oder für Gase zum Antrieb chirurgischer Instrumente vorgesehen sind.
Beispiele für Gase umfassen Sauerstoff, medizinische Luft und Sauerstoff /Distickstoffoxid Gemische.
Dieses Dokument gilt für DRUCKMINDERER,
a) die vom Anwender an Gasflaschen angeschlossen werden sollen,
b) mit fest verbundenen Durchflussmesseinrichtungen, die vom Anwender an Gasflaschen angeschlossen werden sollen,
c) die fester Bestandteil medizinischer Geräte (z. B. Anästhesie Arbeitsplätze, Beatmungsgeräte, Wiederbelebungsgeräte) sind.
Ein DRUCKMINDERER kann mit einem DRUCKAUSGANG oder DURCHFLUSSAUSGANG ausgestattet und einstellbar oder voreingestellt sein.
DRUCKMINDERER sind für den Anschluss an wiederauffüllbare Gasflaschen mit BETRIEBSDRÜCKEN bis 30 000 kPa (300 bar) vorgesehen und können mit Geräten geliefert werden, die den Durchfluss des abgegebenen medizinischen Gases steuern und messen.
Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-débitmètres (ISO 10524-1:2018)
ISO 10524-1:2018 spécifie la conception, la construction, les essais de type et les exigences de marquage s'appliquant aux détendeurs (tels que définis en 3.18), destinés à l'administration de gaz médicaux et de leurs mélanges dans le cadre du traitement, de la prise en charge, de l'évaluation diagnostique et des soins portés aux patients, ou de gaz destinés aux instruments chirurgicaux.
De tels gaz sont par exemple l'oxygène, l'air médical et les mélanges d'oxygène et de protoxyde d'azote.
ISO 10524-1:2018 s'applique aux détendeurs:
a) destinés à être branchés sur les bouteilles par l'opérateur;
b) à débitmètre intégré destinés à être branchés sur les bouteilles par l'opérateur;
c) qui font partie intégrante d'un matériel médical (par exemple les stations d'anesthésie, les ventilateurs pulmonaires, les appareils de réanimation).
Un détendeur peut être réglable ou préréglé et muni d'une sortie de pression et/ou d'une sortie de débit.
Les détendeurs sont destinés à être connectés sur des bouteilles à gaz rechargeables dont la pression de service peut atteindre 30 000 kPa (300 bar) et peuvent comporter des dispositifs de régulation et de mesure du débit des gaz médicaux délivrés.
Tlačni regulatorji za medicinske pline - 1. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki (ISO 10524-1:2018)
Ta dokument določa projektiranje, konstrukcijo, tipsko preskušanje in zahteve za označevanje tlačnih regulatorjev (kot je določeno v točki 3.18), namenjenih za dovajanje medicinskih plinov in njihovih zmesi pri zdravljenju, upravljanju, diagnostičnem vrednotenju ter 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 tlačne regulatorje:
a) namenjene, da jih na cilindre priključi upravljavec;
b) z vgrajenimi pretočnimi merilniki, namenjene, da jih na cilindre priključi upravljavec;
c) ki so del medicinske opreme (npr. delovnih postaj za anestezijo, pljučnih ventilatorjev, naprav za oživljanje).
Tlačni regulator lahko vključujejo izhodno odprtino za tlak ali z odprtino za pretok, lahko pa so prilagodljivi ali predhodno nastavljeni.
Tlačni regulatorji so namenjeni namestitvi na jeklenke, ki jih je mogoče polniti, z delovnim tlakom do 30.000 kPa (300 barov) in lahko vključujejo naprave, ki nadzorujejo in merijo pretok dovajanega medicinskega plina.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-1:2006
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO 7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL ,62
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO 10524-1:2018)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-
débitmètres (ISO 10524-1:2018)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2019
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 10524-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-1:2006
English Version
Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow-
metering devices (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Druckminderer zur Verwendung mit medizinischen
Partie 1: Détendeurs et détendeurs-débitmètres (ISO Gasen - Teil 1: Druckminderer und Druckminderer mit
10524-1:2018) Durchflussmessgeräten (ISO 10524-1:2018)
This European Standard was approved by CEN on 13 December 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 10524-1:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10524-1:2019) 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 10524-1:2006.
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 10524-1:2018 has been approved by CEN as EN ISO 10524-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 10524-1
Second edition
2018-01
Pressure regulators for use with
medical gases —
Part 1:
Pressure regulators and pressure
regulators with flow-metering devices
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs-débitmètres
Reference number
ISO 10524-1:2018(E)
©
ISO 2018
ISO 10524-1:2018(E)
© ISO 2018, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2018 – All rights reserved
ISO 10524-1:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 4
5 General requirements . 4
5.1 Safety . 4
5.2 Usability . 4
5.3 Alternative construction . 4
5.4 Materials . 4
6 Design requirements . 5
6.1 General . 5
6.2 Indicator for cylinder pressure or cylinder content . 6
6.2.1 General. 6
6.2.2 Pressure gauges, pressure indicators, and flowgauges . 6
6.3 Integrated electronic device . 6
6.4 Connections . 6
6.4.1 Inlet connector. 6
6.4.2 Outlet connectors . 7
6.5 * Requirements for outlet pressure . 7
6.5.1 Pressure outlet . 7
6.5.2 Flow outlet . 8
6.6 Flow-metering device . 8
6.7 Flow control and indication . 8
6.8 Pressure-adjusting device . 8
6.9 * Filtration . 9
6.10 * Pressure-relief device . 9
6.11 Leakage . 9
6.12 Mechanical strength .10
6.12.1 Resistance of the high-pressure side .10
6.12.2 Resistance of the low-pressure side to pneumatic pressure .10
6.12.3 Resistance of the low-pressure side to inlet pressure, P .10
6.13 * Resistance to ignition .10
6.14 Requirements for pressure regulators with flowmeters .10
6.14.1 Calibration .10
6.14.2 Accuracy of flow .10
6.14.3 Stability of flow .11
6.14.4 Legibility .11
6.14.5 Flow control device .11
6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges.11
6.15.1 Calibration .11
6.15.2 Accuracy of flow .11
6.15.3 Stability of flow .11
6.16 Requirements for pressure regulators fitted with fixed orifices .12
6.16.1 Stability and accuracy of flow .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.