EN ISO 10524-1:2019/A1:2023

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)

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und Druckminderer mit Durchflussmessgeräten - Änderung 1 (ISO 10524-1:2018/Amd 1:2023)

No scope available

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs-débitmètres - Amendement 1 (ISO 10524-1:2018/Amd 1:2023)

Tlačni regulatorji za medicinske pline - 1. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki - Dopolnilo A1 (ISO 10524-1:2018/Amd 1:2023)

General Information

• Status: Published
• Publication Date: 31-Oct-2023
• 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: 01-Nov-2023
• Completion Date: 01-Nov-2023
• Ref Project: SIST EN ISO 10524-1:2019/A1:2024 - 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)

Relations

• Amends: EN ISO 10524-1:2019 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)
• Effective Date: 07-Dec-2022

Overview

EN ISO 10524-1:2019/A1:2023 (ISO 10524-1:2018/Amd 1:2023) is an amendment to the international and European standard for pressure regulators for use with medical gases - Part 1, covering pressure regulators and pressure regulators with flow‑metering devices. Approved by CEN in June 2023 and published as an amendment in November 2023, it updates specific connector and outlet pressure requirements and bibliographic references. The amendment was prepared by ISO/TC 121 (Anaesthetic and respiratory equipment) in collaboration with CEN/TC 215.

Key topics and requirements

This amendment focuses on clarifying and tightening requirements related to outlets and outlet pressure. Principal changes include:

• Scope exclusion for integral devices: Several provisions apply except for pressure regulators that are an integral part of medical equipment, i.e., standalone regulators are targeted.
• Outlet connector requirements (clause changes to 6.4.2.1 and 6.4.2.3):
  • Outlet connector(s) must comply with ISO 9170-1 for specified gases or use a recognized gas‑specific system for other medical gases.
  • Examples of recognized connector systems noted include Diameter-Indexed Safety System (DISS) and non-interchangeable screw-threaded (NIST) connectors.
• Outlet pressure setting (6.5.1.1):
  • When a pressure regulator is fitted with a pressure outlet (and is not integral to another device), the outlet pressure shall be pre-set.
• Bibliography update:
  • Reference updated from EIGA Doc 180/13 to EIGA Doc 180/19.

These targeted amendments refine connector compatibility and safety measures to reduce risk of misconnections and ensure predictable outlet pressures for medical gas applications.

Applications and users

This amendment is directly relevant to:

• Manufacturers of medical gas pressure regulators and flow‑metering devices (design, testing, marking)
• Medical device designers and integrators who incorporate regulators into gas delivery systems
• Biomedical engineering and maintenance teams in hospitals and clinics (specification and procurement)
• Regulatory and compliance professionals ensuring conformity with European and international standards Practical applications include regulators used in anaesthesia machines, oxygen delivery, respiratory therapy equipment and portable medical gas systems.

Related standards

• ISO 9170-1 - Connectors for medical gas supply systems (referenced for gas‑specific outlet connectors)
• EIGA Doc 180/19 - Updated industry guidance cited in the bibliographic section
• ISO/TC 121 and CEN/TC 215 are the technical committees behind the standard.

This amendment helps ensure safer, interoperable medical gas regulator designs by clarifying connector and outlet‑pressure requirements - essential for minimizing misconnections and ensuring consistent gas delivery in clinical settings.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2024
Tlačni regulatorji za medicinske pline - 1. del: Tlačni regulatorji in tlačni regulatorji
s pretočnimi merilniki - Dopolnilo A1 (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 (ISO 10524-1:2018/Amd
1:2023)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten - Änderung 1 (ISO 10524-1:2018/Amd
1:2023)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et
détendeurs-débitmètres - Amendement 1 (ISO 10524-1:2018/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2019/A1:2023
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.

EN ISO 10524-1:2019/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.10
English Version
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)
Détendeurs pour l'utilisation avec les gaz médicaux - Druckminderer zur Verwendung mit medizinischen
Partie 1: Détendeurs et détendeurs-débitmètres - Gasen - Teil 1: Druckminderer und Druckminderer mit
Amendement 1 (ISO 10524-1:2018/Amd 1:2023) Durchflussmessgeräten - Änderung 1 (ISO 10524-
1:2018/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 10524-1:2019; it was approved by CEN on 18 June 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-1:2019/A1:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10524-1:2019/A1:2023) 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 Amendment to the European Standard EN ISO 10524-1:2019 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2024, and
conflicting national standards shall be withdrawn at the latest by May 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10524-1:2018/Amd 1:2023 has been approved by CEN as EN ISO 10524-
1:2019/A1:2023 without any modification.

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