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CEN

EN ISO 10524-2:2019

(Main)

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

ISO 10524-2:2018 specifies design, construction, type testing, and marking requirements for manifold pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended for use in medical gas pipeline systems.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
ISO 10524-2:2018 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly.
Manifold pressure regulators are intended to be connected to a manifold system which has a nominal inlet pressure, P1 of up to 30 000 kPa (300 bar).
Line pressure regulators are intended to be connected downstream of the manifold pressure regulator with a supply pressure up to 3 000 kPa (30 bar).
ISO 10524-2:2018 does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE       Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079‑3.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2018)

Dieses Dokument legt die Ausführung, Konstruktion, Typprüfung und die Anforderungen an die Kennzeichnung von HAUPTSTELLENDRUCKREGLERN (wie in 3.5 definiert) und LEITUNGSDRUCKMINDERERN (wie in 3.7 definiert) zur Ver¬wendung in ROHRLEITUNGSSYSTEMEN FÜR MEDIZINISCHE GASE fest.
Beispiele für Gase umfassen Sauerstoff, medizinische Luft und Sauerstoff /Distickstoffoxid Gemische.
Dieses Dokument gilt für HAUPTSTELLENDRUCKREGLER und LEITUNGSDRUCKMINDERER, die als individuelle Ein-heiten geliefert werden oder für die entsprechenden Bauteile innerhalb einer Baugruppe.
HAUPTSTELLENDRUCKREGLER sind für den Anschluss an ein GASFLASCHENANSCHLUSSSYSTEM mit einem NENN-VORDRUCK P1 von bis zu 30 000 kPa (300 bar) vorgesehen.
LEITUNGSDRUCKMINDERER sind für den Anschluss hinter dem HAUPTSTELLENDRUCKREGLER mit einem Versorgungsdruck von bis zu 3 000 kPa (30 bar) vorgesehen.
Dieses Dokument gilt nicht für DRUCKMINDERER zur Verwendung mit Vakuum Rohrleitungssystemen.
ANMERKUNG   Anforderungen an DRUCKMINDERER zur Verwendung mit Vakuum Rohrleitungssystemen sind in ISO 10079 3 erfasst.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et de canalisations (ISO 10524-2:2018)

ISO 10524-2:2018 spécifie la conception, la construction, les essais de type et les exigences de marquage s'appliquant aux détendeurs de rampes (tels que définis en 3.7) et aux détendeurs de canalisations (tels que définis en 3.5), destinés aux réseaux de distribution de gaz médicaux.
De tels gaz sont par exemple l'oxygène, l'air médical et les mélanges d'oxygène et de protoxyde d'azote.
ISO 10524-2:2018 s'applique aux détendeurs de rampes et aux détendeurs de canalisations fournis sous la forme d'unités individuelles ou faisant partie d'éléments à assembler.
Les détendeurs de rampes sont destinés à être raccordés à un système de rampe dont la pression nominale d'alimentation, P1 peut atteindre 30 000 kPa (300 bar).
Les détendeurs de canalisations sont destinés à être raccordés en aval du détendeur de rampe d'une pression d'alimentation maximale de 3 000 kPa (30 bar).
ISO 10524-2:2018 ne s'applique pas aux détendeurs utilisés avec les systèmes d'aspiration.
NOTE       Les exigences relatives aux détendeurs utilisés avec les systèmes d'aspiration sont décrites dans l'ISO 10079‑3.

Tlačni regulatorji za medicinske pline - 2. del: Tlačni regulatorji v razdelilnikih in ceveh (ISO 10524-2:2018)

Ta dokument določa projektiranje, konstrukcijo, tipsko preskušanje in zahteve za označevanje tlačnih regulatorjev v razdelilnikih (kot je določeno v točki 3.7) ter tlačnih regulatorjev v ceveh (kot je določeno v točki 3.5), namenjenih za uporabo v sistemih napeljav za medicinske pline.
Primeri plinov: kisik, medicinski zrak in mešanice kisika/dušikovega oksida.
Ta dokument se uporablja za tlačne regulatorje v razdelilnikih in tlačne regulatorje v ceveh, dobavljene kot posamezne enote ali kot ustrezne komponente, vgrajene znotraj sestava.
Tlačni regulatorji v razdelilnikih so namenjeni za priključitev na razdelilni sistem z nazivnim vhodnim tlakom P1 30.000 kPa (300 barov).
Tlačni regulatorji v ceveh so namenjeni za priključitev na izhodni strani tlačnega regulatorja v razdelilniku z vhodnim tlakom do 3000 kPa (30 barov).
Ta dokument se ne uporablja za tlačne regulatorje, namenjene za uporabo z vakuumskimi cevnimi sistemi.
OPOMBA: Zahteve za tlačne regulatorje, namenjene za uporabo z vakuumskimi cevnimi sistemi, so zajete v standardu ISO 10079-3.

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 10524-2:2019 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

Relations

Replaces
EN ISO 10524-2:2006 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
Effective Date
08-Jun-2022

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Standards Content (Sample)


SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-2:2006
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYUD]GHOLOQLNLKLQ
FHYHK ,62
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure
regulators (ISO 10524-2:2018)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2:
Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2018)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et
de canalisations (ISO 10524-2:2018)
Ta slovenski standard je istoveten z: EN ISO 10524-2:2019
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 10524-2
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-2:2006
English Version
Pressure regulators for use with medical gases - Part 2:
Manifold and line pressure regulators (ISO 10524-2:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Druckminderer zur Verwendung mit medizinischen
Partie 2: Détendeurs de rampes et de canalisations Gasen - Teil 2: Hauptstellendruckregler und
(ISO 10524-2:2019) Leitungsdruckminderer (ISO 10524-2:2019)
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 10524-2:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10524-2:2019) 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 10524-2:2006.
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 10524-2:2018 has been approved by CEN as EN ISO 10524-2:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 10524-2
Second edition
2018-01
Pressure regulators for use with
medical gases —
Part 2:
Manifold and line pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 2: Détendeurs de rampes et de canalisations
Reference number
ISO 10524-2:2018(E)
©
ISO 2018
ISO 10524-2:2018(E)
© ISO 2018
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
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 10524-2:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 4
5 General requirements . 4
5.1 Safety . 4
5.2 Usability . 4
5.3 Alternative construction . 4
5.4 Materials . 5
6 Design requirements . 6
6.1 General . 6
6.2 Pressure gauges. 6
6.3 Integrated digital gauges . 6
6.4 Pressure-adjusting device . 6
6.5 Filtration . 7
6.6 Mechanical strength . 7
6.6.1 Resistance of the high-pressure side . 7
6.6.2 Resistance of the low-pressure side to pneumatic pressure . 7
6.6.3 Resistance of the low pressure side to P .
1 7
6.7 Endurance . 7
6.8 Manifold pressure regulators . 8
6.8.1 * Inlet connector . 8
6.8.2 Outlet connector . . . 8
6.8.3 Leakage . 8
6.8.4 Functional and flow characteristics . 8
6.8.5 Pressure-relief device. 9
6.8.6 * Resistance to ignition . 9
6.8.7 Nominal inlet pressure . 9
6.9 Line pressure regulators. 9
6.9.1 * Inlet connector . 9
6.9.2 Outlet connector . . . 9
6.9.3 Leakage . 9
6.9.4 Outlet pressure variation limits .10
6.9.5 * Resistance to ignition of sealing materials and lubricants .10
6.9.6 Nominal inlet pressure .10
7 Construction requirements .10
7.1 * Cleanliness .10
7.2 Lubricants .10
8 Test methods for type tests .11
8.1 General conditions .11
8.1.1 General.11
8.1.2 Ambient conditions .11
8.1.3 Test gas .
...

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Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilato

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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