ISO 10524: pressure regulators for medical gases

The four parts and their editions

Scope in plain words

Part 1 sets design, construction, type testing and marking requirements for pressure regulators, including those with an integral flowmeter, used to deliver medical gases or to drive surgical tools. They may be fitted to a cylinder by the operator or built into equipment.

Part 2 applies to the regulators inside a medical gas pipeline system: manifold pressure regulators, with a nominal inlet pressure of up to 300 bar (30 000 kPa), and line pressure regulators. Part 3 covers cylinder valves with an integrated pressure regulator (VIPRs) on refillable medical gas cylinders. Part 4 covers low-pressure regulators, including versions with integral flowmeters, connected to the terminal units of pipelines that comply with ISO 7396-1.

Edition in force and status

ISO lists Parts 1, 2 and 4 as confirmed at their last systematic review. Part 1 has an Amendment 1, published in October 2023, so a full reference is ISO 10524-1:2018 + Amd 1:2023. Part 3 is marked as to be revised: a third edition, ISO/FDIS 10524-3, is at stage 50.00, and ISO expects it to replace the 2019 edition within the coming months. Check iso.org before naming the edition of Part 3 in a specification.

What it means for a hospital or designer

• Supply sources and distribution: manifold and line regulators belong to Part 2. They are part of the pipeline system governed by ISO 7396-1, which covers supply systems, distribution, control and alarms.
• At the bedside: low-pressure regulators connected to a terminal unit, including those with an integral flowmeter, belong to Part 4; the terminal unit itself is covered by ISO 9170-1.
• Cylinders: regulators fitted to a cylinder are Part 1; cylinder valves with an integrated pressure regulator (VIPRs) are Part 3.
• In tenders, name the part and edition (for example ISO 10524-2:2018) rather than ISO 10524 alone, because each part covers a different device.

Related standards

• ISO 7396-1: pipeline systems for compressed medical gases and vacuum.
• ISO 9170-1: terminal units for compressed medical gases and vacuum.
• ISO 21969: high-pressure flexible connections between cylinders and manifolds, for nominal filling pressures up to 25 000 kPa at 15 °C.
• ISO 5359: low-pressure hose assemblies for medical gases, up to 1 400 kPa.