SIST EN ISO 7396-3:2025 PDF

Overview

EN ISO 7396-3:2025 - "Medical gas pipeline systems - Part 3: Proportioning units for the production of synthetic medical air" defines requirements for devices that produce synthetic medical air by proportioning (mixing) oxygen and nitrogen. Prepared by ISO/TC 121 in collaboration with CEN/TC 215 and approved by CEN in 2025, this standard applies to proportioning units intended as components of medical gas supply systems that feed medical gas pipeline distribution compliant with ISO 7396-1.

Key topics and technical requirements

This standard covers the full lifecycle of proportioning units with emphasis on safety, usability and conformity. Major technical topics include:

• Design requirements
  • Environmental conditions, outlet pressure and specification for synthetic medical air
  • Inlet and outlet connectors, pressure-equalizing systems and sample ports
• Safety and reliability
  • Mechanical strength, leakage control, filtration, non-return and shut-off valves
  • Pressure-relief devices and requirements for clean construction and suitable lubricants
• Monitoring, alarms and control
  • Oxygen analysers, indication of functional parameters, monitoring and alarm systems
  • Record capability and software requirements for control/monitoring functions
• Electrical and electromagnetic compliance
  • Electromagnetic compatibility (EMC) and electrical safety tests
• Type testing and verification
  • Test methods for performance, leakage, alarms, mechanical strength, EMC and electrical safety
• Documentation and labelling
  • Marking, packaging, and comprehensive manufacturer information for installation, use and maintenance

The standard also contains informative annexes (typical unit examples, compliance documentation forms, rationale, hazard list) to aid implementation.

Applications and who uses it

EN ISO 7396-3:2025 is intended for:

• Manufacturers of proportioning units and medical gas equipment
• Hospital biomedical and clinical engineers specifying or integrating synthetic medical air sources
• Medical gas system designers and installers working with pipeline distribution systems
• Regulators, conformity assessors and maintenance personnel responsible for safe production and monitoring of medical air

Practical applications include on-site production of medical air for patient respiratory support, anaesthesia backup supplies and powering certain surgical tools where mixed gas supply is required.

Related standards

• ISO 7396-1 / EN ISO 7396-1 - Requirements for medical gas pipeline supply systems (distribution)
• ISO 7396 series - guidance on medical gas systems and interfaces
• Applicable EMC and electrical safety standards referenced within EN ISO 7396-3:2025

Keywords: EN ISO 7396-3:2025, medical gas pipeline systems, proportioning units, synthetic medical air, oxygen nitrogen mixing, ISO 7396-1, medical air production.