oSIST prEN ISO 10524-3:2025
(Main)Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO/DIS 10524-3:2025)
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO/DIS 10524-3:2025)
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/DIS 10524-3:2025)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans les robinets des bouteilles à gaz (VIPR) (ISO/DIS 10524-3:2025)
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/DIS 10524-3:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2025
Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu
cilindričnih ventilov jeklenk (ISO/DIS 10524-3:2025)
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (VIPRs) (ISO/DIS 10524-3:2025)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO/DIS 10524-3:2025)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles à gaz (VIPR) (ISO/DIS 10524-3:2025)
Ta slovenski standard je istoveten z: prEN ISO 10524-3
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 Tlačni regulatorji Pressure regulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 10524-3
ISO/TC 121/SC 6
Pressure regulators for use with
Secretariat: ANSI
medical gases —
Voting begins on:
Part 3: 2025-03-10
Pressure regulators integrated with
Voting terminates on:
2025-06-02
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à
gaz (VIPR)
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
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Reference number
ISO/DIS 10524-3:2025(en)
DRAFT
ISO/DIS 10524-3:2025(en)
International
Standard
ISO/DIS 10524-3
ISO/TC 121/SC 6
Pressure regulators for use with
Secretariat: ANSI
medical gases —
Voting begins on:
Part 3:
Pressure regulators integrated with
Voting terminates on:
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à
gaz (VIPR)
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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or ISO’s member body in the country of the requester.
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Published in Switzerland Reference number
ISO/DIS 10524-3:2025(en)
ii
ISO/DIS 10524-3:2025(en)
14 Contents
15 Introduction . 8
16 1 Scope . 9
17 2 Normative references . 9
18 3 Terms and definitions . 10
19 4 Nomenclature . 13
20 5 General requirements. 13
21 5.1 Safety . 13
22 5.2 Usability . 14
23 5.3 Materials . 14
24 5.4 Potential contamination of the gas pathway . 15
25 5.5 Cleaning and disinfection . 15
26 6 Design requirements . 15
27 6.1 Environmental conditions . 15
28 6.1.1 Road transport and storage . 16
29 6.1.2 VIPR transient operating conditions . 16
30 6.1.3 VIPR clinical use . 16
31 6.2 Integrated electronic device . 16
32 6.3 Filling port . 17
33 6.4 Connections . 18
34 6.4.1 Valve inlet connection . 18
35 6.4.2 Flow outlet . 18
36 6.4.3 Pressure outlet . 18
37 6.5 Content indicator . 18
38 6.6 Filtration . 19
39 6.7 Primary valve operating mechanism . 19
40 6.7.1 General . 19
41 6.7.2 Resistance to excessive torques . 19
42 6.8 Residual pressure . 19
43 6.8.1 Residual pressure device. 19
44 6.8.2 Means of venting the residual pressure . 20
45 6.9 Pressure-relief device. 20
46 6.9.1 General . 20
47 6.9.2 Leakage . 20
48 6.9.3 Opening pressure . 20
49 6.9.4 Closing pressure . 20
50 6.9.5 Minimum discharge capacity . 21
51 6.10 Additional features . 21
52 6.11 Leakage . 21
53 6.11.1 Leakage in transport and storage conditions . 21
54 6.11.2 Internal leak tightness. 21
55 6.11.3 External leak tightness . 21
56 6.11.4 Internal leakage through the pressure regulator valve . 22
57 6.12 Mechanical strength . 22
58 6.12.1 Resistance of the high-pressure side. 22
59 6.12.2 Resistance of the low-pressure side to excessive pressure . 22
60 6.12.3 Resistance of the low-pressure side to P1 . 22
61 6.12.4 Impact test . 22
© ISO/DIS 10524-3:2024(1) – All rights reserved
iii
ISO/DIS 10524-3:2025(en)
62 6.13 Resistance to ignition . 22
63 6.14 Requirements for VIPR fitted with an integral flow control device . 23
64 6.15 Guard . 23
65 6.16 Endurance . 23
66 6.16.1 Integral flow control device . 23
67 6.16.2 Filling port non-return valve . 23
68 6.16.3 Isolating valve fitted to the filling port . 24
69 6.16.4 Primary valve operating mechanism . 24
70 6.16.5 Pressure regulator . 24
71 7 Performance requirements . 25
72 7.1 VIPRs fitted with a pressure outlet . 25
73 7.1.1 Outlet pressure (P ) limits . 25
74 7.1.2 Multiple pressure outlets . 25
75 7.2 VIPRs fitted with an integral flow control device . 25
76 7.2.1 Flow outlet pressure . 25
77 7.2.2 Stability and accuracy of flow . 25
78 8 Construction requirements . 25
79 8.1 Cleanliness . 25
80 8.2 Lubricants . 26
81 8.3 Loosening torques . 26
82 8.3.1 Filling port . 26
83 8.3.2 Outlet connector . 26
84 8.3.3 Integral flow control device . 26
85 8.3.4 Content indicator. 26
86 8.3.5 Inlet connection . 27
87 9 Marking, and packaging . 27
88 9.1 Marking .
...
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