ISO 10524-4-2008 PDF

Full title and description

Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008). Specifies safety, performance, design and test requirements for low-pressure regulators intended for use with medical gases in patient care, anaesthesia and for driving surgical tools, and covers regulators used with pipeline terminal units, regulator-mounted terminal units and integral flow‑metering devices.

Abstract

ISO 10524-4:2008 defines requirements and test methods for low-pressure pressure regulators used with medical gases (oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified gas mixtures, air or nitrogen for driving surgical tools, and oxygen-enriched air). The standard addresses mechanical design, materials, gas-specific connections, inlet/outlet pressure limits, flow‑metering interfaces, environmental and temperature requirements, safety features (including controlled relief and ignition resistance), and conformity evidence in line with medical-device risk management practices.

General information

• Status: Published (International Standard).
• Publication date: First edition published 1 June 2008 (CEN adoption approved 29 May 2008).
• Publisher: International Organization for Standardization (ISO); adopted as EN ISO 10524-4:2008 by CEN and adopted in various national catalogues.
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment); also listed with 23.060.40 in some national records.
• Edition / version: First edition, ISO 10524-4:2008 (2008-06-01).
• Number of pages: ISO English edition: 30 pages (ISO PDF); EN adoption versions and translated national publications may be longer (commonly 41 pages where national forewords/annexes are included).

Scope

This part of ISO 10524 applies to low-pressure regulators that reduce pressure in medical gas pipeline systems or downstream equipment to levels suitable for medical devices or direct patient delivery. It covers low-pressure regulators connected to terminal units of medical gas pipeline systems (as defined in ISO 7396-1), low-pressure regulators with integral flow‑metering devices, regulators connected to terminal units attached downstream of higher-stage regulators (ISO 10524-1/3), and operator-adjustable low-pressure regulators used for air or nitrogen to drive surgical tools. The standard sets limits on maximum inlet pressures, defines low pressure as pressures up to 2 000 kPa for specified applications, and excludes high-stage and cylinder-integrated regulator types covered in other parts of ISO 10524.

Key topics and requirements

• Scope and definitions specific to low-pressure regulators and flow‑metering interfaces.
• Safety and risk management: requirements to limit hazards under normal and single-fault conditions, in line with ISO 14971 principles.
• Material and construction criteria: resistance to ignition, auto‑ignition temperature considerations, permitted operating temperature range (typically −20 °C to +60 °C), and prohibition of plated springs or highly stressed gas-contacting parts.
• Design limits: maximum inlet pressures referenced to ISO 7396-1 and related parts (e.g., 1 000 kPa for most gases; up to 2 000 kPa where air/nitrogen drive for surgical tools applies).
• Gas-specific connections and prevention of misconnections between different gas services.
• Performance tests and test methods for mechanical strength, pressure relief, leakage, flow characteristics, and functional behaviour after environmental exposure and transport.
• Marking, instructions for use, and conformity evidence (including manufacturer documentation to demonstrate compliance with stated requirements).

Typical use and users

Primary users and stakeholders include medical gas equipment manufacturers, hospital biomedical engineering departments, medical gas pipeline system designers and installers, regulatory bodies and conformity-assessment organizations, test laboratories, and procurement/specification engineers responsible for medical gas distribution and clinical equipment interfacing with low-pressure regulators.

Related standards

ISO 10524 series (Parts 1, 2, 3 and 4); ISO 7396-1 (medical gas pipeline systems — pipeline systems for compressed medical gases and vacuum); ISO 14971 (risk management for medical devices); ISO 11114-3 (compatibility of materials with oxygen — determination of auto‑ignition characteristics); ISO 5359 (low-pressure hose assemblies for use with medical gases); ISO 9170-1 (terminal units for medical gas pipeline systems); relevant national/adopted standards such as EN ISO 10524-4:2008 and CAN/CSA Z10524-4:12 (adoptions of ISO 10524-4:2008 with national deviations).

Keywords

medical gas, pressure regulator, low-pressure regulator, flow-metering device, medical gas pipeline, ISO 10524, safety, risk management, gas-specific connection, testing, medical equipment.

FAQ

Q: What is this standard?

A: ISO 10524-4:2008 is the part of the ISO 10524 series that prescribes requirements and test methods for low-pressure pressure regulators intended for use with medical gases.

Q: What does it cover?

A: It covers regulator types intended to reduce pipeline or regulator outlet pressures to levels suitable for medical devices or patient delivery, including units connected to terminal pipeline units, regulators with integral flow‑metering, and operator-adjustable regulators for driving surgical tools. It specifies design, material, performance and testing requirements and safety provisions.

Q: Who typically uses it?

A: Equipment manufacturers, hospital clinical engineering and facilities teams, pipeline system designers and installers, testing laboratories, conformity assessment bodies and regulators use this standard to design, specify, test and approve low-pressure medical gas regulators.

Q: Is it current or superseded?

A: ISO 10524-4:2008 is the first edition published 1 June 2008 and has been adopted into several national and regional catalogues (for example EN ISO 10524-4:2008 and national adoptions such as CAN/CSA Z10524-4:12). Users should verify the current status in the ISO Catalogue or with their national standards body to confirm whether a newer revision or replacement has been issued since 2008 and to check for national deviations.

Q: Is it part of a series?

A: Yes — it is Part 4 of the ISO 10524 series (Pressure regulators for use with medical gases). Other parts in the series address pressure regulators with flow‑metering (Part 1), manifold and line pressure regulators (Part 2), and regulators integrated with cylinder valves (Part 3).

Q: What are the key keywords?

A: Medical gas, low-pressure regulator, pressure regulator, flow-metering, medical gas pipeline, ISO 10524-4, safety, testing, gas-specific connection.