SIST EN ISO 10524-1:2019 PDF

Overview

EN ISO 10524-1:2019 (identical to ISO 10524-1:2018) specifies design, construction, type‑testing and marking requirements for pressure regulators for use with medical gases. It covers regulators and regulators with flow‑metering devices intended for patient treatment, diagnostics or to drive surgical tools. Typical gases include oxygen, medical air and oxygen/nitrous‑oxide mixtures. The standard applies to:

• regulators connected to cylinders by the operator;
• regulators with integral flow‑metering devices connected to cylinders by the operator;
• regulators that are integral parts of medical equipment (e.g., anaesthetic workstations, ventilators, resuscitators).

Regulators covered may provide a pressure outlet or a flow outlet, be adjustable or pre‑set, and are intended for refillable cylinders up to 30 000 kPa (300 bar).

Key topics and requirements

The standard defines technical and safety requirements including:

• General safety and usability - ergonomic and safe operation for clinical environments.
• Materials and construction - cleanliness, approved lubricants, mechanical strength and resistance to ignition.
• Design features - cylinder pressure indicators, integrated electronic devices, inlet and outlet connectors, and marking.
• Outlet performance - requirements for pressure outlets and flow outlets, including limits and stability.
• Flow‑metering and flow control - calibration, accuracy, stability, legibility and flow control device requirements.
• Filtration and pressure‑relief devices - required features and test methods.
• Leakage and endurance - external/internal leakage limits and endurance testing for flow selectors and regulators.
• Type test methods - ambient/test gas/reference conditions, test schedule, methods to determine outlet pressure, pressure‑relief testing, leakage and mechanical strength tests.

The document provides detailed test procedures and acceptance criteria for type testing and marking to demonstrate conformity.

Practical applications