Overview
EN ISO 9360-1:2009 (ISO 9360-1:2000) specifies requirements and test methods for heat and moisture exchangers (HMEs) used to humidify respired gases in humans. It covers HMEs intended primarily for patients with minimum tidal volumes of 250 ml, including devices that incorporate breathing system filters and at least one machine port. The standard defines terms, connector requirements, packaging and marking, and laboratory test methods used to evaluate HME performance.
Key topics and technical requirements
- Scope and definitions: Clear definitions of HME components (patient port, machine port, accessory port), internal volume and intended use for tidal volumes ≥ 250 ml.
- Connectors and interfaces: Compatibility with standard anaesthetic and respiratory connectors (normative references include ISO 5356 series).
- Performance test methods: Laboratory methods are specified for measuring moisture output (moisture loss), pressure drop, gas leakage, and mechanical compliance. These tests allow objective comparison of humidification efficiency and breathing resistance.
- Packaging and sterility: Requirements for packaging of sterile HMEs reference packaging standards (e.g., ISO 11607).
- Marking and information: Requirements for labeling, instructions and symbols to ensure safe selection and use.
- Safety and regulatory alignment: The European Annex ZA maps clauses of the standard to Essential Requirements of EU Directive 93/42/EEC for medical devices, supporting conformity assessment.
Practical applications
- Ensures consistent humidification performance of HMEs used during anaesthesia, intensive care ventilation and transport ventilation where tidal volumes are ≥ 250 ml.
- Provides manufacturers with standardized test methods and design requirements to support product development, quality control and regulatory submissions.
- Helps clinical engineers, procurement teams and hospital staff compare devices on objective performance metrics (moisture delivery, resistance, leak tightness).
- Assists notified bodies and testing laboratories in verifying conformity with recognized international requirements.
Who should use this standard
- Medical device manufacturers and R&D engineers designing HMEs and combined filter–HMEs.
- Testing laboratories performing performance, leakage and compliance tests.
- Regulatory affairs professionals preparing CE/UKCA technical documentation.
- Clinicians, respiratory therapists and biomedical engineers selecting humidification devices for ventilated patients.
Related standards
Keywords: EN ISO 9360-1:2009, ISO 9360-1, heat and moisture exchangers, HMEs, humidifying respired gases, anaesthetic equipment, respiratory equipment, tidal volume 250 ml.
