ISO 7396-3:2025

Overview

ISO 7396-3:2025 - Medical gas pipeline systems - Part 3: Proportioning units for the production of synthetic medical air specifies requirements for the design, construction, operation and testing of devices that produce synthetic medical air by blending oxygen and nitrogen. It applies to proportioning units used as components of a medical gas supply system that feeds a pipeline distribution system complying with ISO 7396-1. The standard focuses on safety, gas quality conformity, monitoring, cleanliness and documentation for proportioning units.

Key Topics and Requirements

Highlights of technical topics covered by ISO 7396-3:2025:

• Scope & applicability: Proportioning units that produce synthetic medical air and air for driving surgical tools through defined oxygen/nitrogen blends.
• Design requirements: Environmental conditions, gas specification management, outlet/inlet connectors, pressure‑equalizing systems and outlet pressure controls.
• Safety systems: Monitoring and alarm systems, manual and automatic shut‑off valves, non‑return and pressure‑relief valves, mechanical strength and leakage control.
• Gas quality control: Oxygen analysers, sample ports, filtration and methods to demonstrate compliance of the produced air with the required specification.
• Electrical & software requirements: Electromagnetic compatibility (EMC), electrical safety and software integrity for control/monitoring functions.
• Construction and cleanliness: Material selection, cleanliness, approved lubricants and enclosure requirements to prevent contamination.
• Testing & conformity: Type test methods for gas composition, leakage, alarms, mechanical strength, performance, EMC and electrical safety.
• Marking, packaging & documentation: Manufacturer supplied information for installation, use, maintenance and records capability for monitoring and traceability.

Applications and Who Uses This Standard

ISO 7396-3:2025 is intended for:

• Manufacturers of proportioning units and medical gas equipment - to design and certify compliant products.
• Hospital biomedical/clinical engineers and facility managers - to select, install and maintain proportioning units in medical gas systems.
• Medical gas system designers and installers - to integrate proportioning units into pipeline supply systems and ensure safe operation.
• Regulatory and compliance teams and test laboratories - to verify performance, safety and gas quality against the standard.
• Procurement specialists - to specify compliant equipment when buying medical gas production units.

Practical benefits include ensuring reliable production of medical‑grade synthetic air, meeting safety and monitoring expectations, and facilitating integration into multi‑source medical gas supply systems.

Related Standards

• ISO 7396-1 - Medical gas pipeline systems: Design, installation and testing of medical gas pipeline distribution systems (covers overall supply system requirements).
• Note: Synthetic medical air may also be referenced as “air, synthetic medicinal” in the European Pharmacopoeia.