ISO 10524-1:2018/Amd 1:2023
(Amendment)Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1
Détendeurs pour l'utilisation avec les gaz médicaux — Partie 1: Détendeurs et détendeurs-débitmètres — Amendement 1
General Information
- Status
- Published
- Publication Date
- 18-Oct-2023
- Technical Committee
- ISO/TC 121/SC 6 - Medical gas supply systems
- Drafting Committee
- ISO/TC 121/SC 6 - Medical gas supply systems
- Current Stage
- 6060 - International Standard published
- Start Date
- 19-Oct-2023
- Due Date
- 18-Nov-2024
- Completion Date
- 19-Oct-2023
Relations
- Effective Date
- 26-Nov-2022
Overview
ISO 10524-1:2018/Amd 1:2023 is the latest amendment to the international standard governing pressure regulators used with medical gases. Published by the International Organization for Standardization (ISO), this standard focuses on pressure regulators and pressure regulators with flow-metering devices specifically designed for medical gas applications. It updates key requirements to ensure safety, reliability, and compatibility within medical gas delivery systems.
This amendment serves as an important technical update reflecting advancements and harmonization with related standards, enhancing the performance criteria and connector compatibility for medical gas pressure regulators. It applies primarily to standalone regulators rather than those integrated into medical equipment.
Key Topics
Pressure Outlet Connectors
The amendment revises specifications for outlet connectors on pressure regulators. Unless integrated within medical equipment, outlet connectors must:- Comply with ISO 9170-1 for specified medical gases
- Utilize gas-specific connector systems such as the diameter-indexed safety system (DISS) or non-interchangeable screw-threaded (NIST) connectors for other gases
Outlet Pressure Settings
Pressure regulators fitted with pressure outlets must have pre-set and controlled outlet pressures, except when the regulator is part of other medical equipment, ensuring consistent and safe medical gas delivery.Standard Reference Updates
Bibliographic references have been updated for coherence with the latest industry documents, including replacing “EIGA Doc 180/13” with “EIGA Doc 180/19.”
Applications
ISO 10524-1:2018/Amd 1:2023 is essential for manufacturers, quality assurance professionals, and regulatory bodies involved in medical gas supply systems. It is used to:
- Design and manufacture pressure regulators tailored for medical gases such as oxygen, nitrous oxide, and other specialty gases
- Ensure safe and standardized connectors, mitigating risks of misconnection or cross-contamination in healthcare facilities
- Maintain compliance with medical device regulations concerning gas delivery and pressure regulation
- Support installation and maintenance practices in hospitals, clinics, and transportable medical gas setups
This amendment helps to optimize patient safety and operational reliability in environments where precise medical gas flow and pressure control are critical.
Related Standards
- ISO 9170-1 - Specifies requirements for gas-specific medical gas connectors, referenced for outlet connector compliance.
- ISO 10524 Series - Other parts addressing various aspects of pressure regulators for medical gases.
- EIGA Documents - Industry guidelines on medical gas safety and handling, including the updated “EIGA Doc 180/19.”
- Diameter-Indexed Safety System (DISS) - A connector system preventing misconnection of medical gases.
- Non-Interchangeable Screw Threaded (NIST) Connectors - Another safety mechanism for gas-specific connections.
Adhering to ISO 10524-1:2018/Amd 1:2023 ensures alignment with globally recognized standards for medical gas pressure regulation, promoting uniformity and enhanced safety in healthcare infrastructures.
For more information, visit the ISO website at www.iso.org or contact your national standards body.
ISO 10524-1:2018/Amd 1:2023 - Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices — Amendment 1 Released:19. 10. 2023
ISO 10524-1:2018/Amd 1:2023 - Détendeurs pour l'utilisation avec les gaz médicaux — Partie 1: Détendeurs et détendeurs-débitmètres — Amendement 1 Released:19. 10. 2023
Frequently Asked Questions
ISO 10524-1:2018/Amd 1:2023 is a standard published by the International Organization for Standardization (ISO). Its full title is "Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1". This standard covers: Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1
ISO 10524-1:2018/Amd 1:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 10524-1:2018/Amd 1:2023 has the following relationships with other standards: It is inter standard links to ISO 10524-1:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 10524-1:2018/Amd 1:2023 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10524-1
Second edition
2018-01
AMENDMENT 1
2023-10
Pressure regulators for use with
medical gases —
Part 1:
Pressure regulators and pressure
regulators with flow-metering devices
AMENDMENT 1
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs-débitmètres
AMENDEMENT 1
Reference number
ISO 10524-1:2018/Amd.1:2023(E)
ISO 10524-1:2018/Amd.1:2023(E)
© ISO 2023
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
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10524-1:2018/Amd.1:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest inform
...
NORME ISO
INTERNATIONALE 10524-1
Deuxième édition
2018-01
AMENDEMENT 1
2023-10
Détendeurs pour l'utilisation avec les
gaz médicaux —
Partie 1:
Détendeurs et détendeurs-
débitmètres
AMENDEMENT 1
Pressure regulators for use with medical gases —
Part 1: Pressure regulators and pressure regulators with flow-
metering devices
AMENDMENT 1
Numéro de référence
ISO 10524-1:2018/Amd.1:2023(F)
ISO 10524-1:2018/Amd.1:2023(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2023
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
ISO 10524-1:2018/Amd.1:2023(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
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L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
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document, l’ISO n'avait pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa
mise en application. Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent
document que des informations plus récentes sont susceptibles de figurer dans la base
...
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