ISO 10524-1-2018 PDF

Full title and description

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow‑metering devices. This international standard specifies design, construction, type testing and marking requirements for pressure regulators intended for the administration of medical gases and for gases used to drive surgical tools.

Abstract

ISO 10524-1:2018 sets out requirements for pressure regulators (including those with integral flow‑metering devices) used with medical gases such as oxygen, medical air and oxygen/nitrous oxide mixtures. It covers regulators intended to be connected to cylinders by the operator and regulators that are an integral part of medical equipment (for example anaesthetic workstations, ventilators and resuscitators). The standard addresses pressure and flow outlets, adjustable or pre‑set devices, and regulators intended for refillable cylinders with working pressures up to 30 000 kPa (300 bar).

General information

• Status: Published; International Standard (confirmed).
• Publication date: 2018-01 (Edition 2: 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (medical equipment).
• Edition / version: Edition 2 (2018); amended by ISO 10524-1:2018/Amd 1:2023.
• Number of pages: 33.

Scope

ISO 10524-1:2018 applies to pressure regulators for medical gases intended for direct cylinder connection by an operator, regulators with integral flow‑metering devices, and regulators that form an integral part of medical equipment. The standard specifies essential design, construction, type test, marking and information requirements to ensure safe and reliable delivery of medical gases (including provisions for pressure and/or flow outlets and limits for cylinder working pressure up to 30 000 kPa / 300 bar).

Key topics and requirements

• Design and construction requirements for medical‑gas pressure regulators (materials, mechanical integrity, safety features).
• Type testing procedures to demonstrate performance, leakage, pressure relief and durability under specified conditions.
• Requirements for regulators with integral flow‑metering devices, including accuracy and marking.
• Marking, labelling and information to be supplied by the manufacturer (identification, operating limits, safety warnings).
• Operational ranges and application limits (e.g., connection to refillable cylinders with working pressures up to 30 000 kPa).

Typical use and users

Used by manufacturers and designers of medical‑gas pressure regulators and assemblies, biomedical engineers, medical device conformity assessment bodies, hospital procurement and clinical engineering teams, and test laboratories responsible for type‑testing and verification of medical gas equipment. The standard supports safe product development, regulatory compliance and procurement of medical gas regulators for clinical settings.

Related standards

ISO 10524-1 is part of the ISO 10524 series addressing pressure regulators for medical gases; closely related documents include ISO 10524-2 (manifold and line pressure regulators) and other medical‑gas and medical‑equipment standards cited by ISO 10524 parts (for example standards covering vacuum pipeline systems and medical gas pipeline systems).

Keywords

medical gas, pressure regulator, flow‑metering device, cylinder regulator, manifold, line regulator, type test, marking, medical equipment, safety, ISO 10524.

FAQ

Q: What is this standard?

A: ISO 10524-1:2018 is an international standard that specifies requirements for pressure regulators and regulators with integral flow‑metering devices intended for use with medical gases.

Q: What does it cover?

A: It covers design, construction, type testing, marking and information requirements for regulators connected to cylinders by the operator and regulators that are integral to medical devices; it includes guidance on outlets (pressure or flow), adjustable or pre‑set devices, and limits for cylinder working pressure (up to 30 000 kPa / 300 bar).

Q: Who typically uses it?

A: Manufacturers of medical‑gas regulators, medical device designers, clinical engineers, conformity assessment bodies, test laboratories and hospital procurement/maintenance teams. These users rely on the standard for safe product design, testing and selection.

Q: Is it current or superseded?

A: The 2018 edition (Edition 2) is published and was reviewed and confirmed in 2023; the document remains current and has one published amendment in 2023.

Q: Is it part of a series?

A: Yes — ISO 10524 is a multipart series. Part 1 addresses cylinder/flow‑metering regulators; Part 2 covers manifold and line pressure regulators. Other related ISO standards address associated medical gas pipeline and vacuum systems.

Q: What are the key keywords?

A: Medical gas, pressure regulator, flow‑metering device, cylinder, manifold regulator, line regulator, type test, marking, safety, ISO 10524.