EN ISO 9360-2:2009 - Overview
EN ISO 9360-2:2009 (ISO 9360-2:2001) is a CEN-adopted international standard for heat and moisture exchangers (HMEs) used to humidify respired gases in tracheostomized patients with minimum tidal volumes of 250 ml. It defines device requirements, test methods and labelling/packaging expectations for HMEs without machine connector ports (including devices that incorporate breathing system filters). The European adoption (EN ISO 9360-2:2009) aligns the standard with EU medical device directives and national implementation across CEN member states.
Key topics and technical requirements
- Scope and purpose
- HMEs intended for tracheostomized patients (tidal volume ≥ 250 ml).
- Connectors and ports
- Patient port: must mate with a 15 mm male connector in accordance with ISO 5356-1.
- Additional ports: where present, connectors for breathing attachments shall be 15 mm male and/or 22 mm conical (ISO 5356-1).
- Accessory ports: must not accept the 15 mm or 22 mm connectors of ISO 5356 series.
- Sterile packaging
- HMEs supplied sterile shall comply with ISO 11607 packaging requirements for terminally sterilized medical devices.
- Performance testing
- Defines test apparatus and reference methods for performance evaluation, notably measurement of moisture loss from a standardized test rig.
- Test rig components include a bidirectional flow generator (mechanically driven piston), a humidity generator (heated water bath, reservoir and thermally insulated chamber), and an air delivery system.
- Environmental test conditions: 23°C ± 2°C, relative humidity 50% ± 20%, atmospheric pressure 86–106 kPa.
- Definitions
- Includes specific terms (e.g., HME internal volume) and references ISO vocabulary standards.
Practical applications and who uses it
- Manufacturers of HMEs and breathing system filters use this standard to design, test and mark devices for clinical use with tracheostomized patients.
- Test laboratories and quality departments apply the specified test methods and environmental conditions to verify moisture retention, connector compatibility and packaging.
- Regulatory and compliance teams use EN ISO 9360-2:2009 to demonstrate conformity with EU Directive 93/42/EEC (medical devices) and for CE marking evidence.
- Procurement officers and clinical engineers consult the standard when specifying HMEs for ICUs, long-term ventilation and tracheostomy care.
Related standards
- ISO 9360-1:2000 (HMEs for minimum tidal volumes of 250 ml - general)
- ISO 4135 (Anaesthetic and respiratory equipment - Vocabulary)
- ISO 5356-1 (Conical connectors - Cones and sockets)
- ISO 11607 (Packaging for terminally sterilized medical devices)
Keywords: EN ISO 9360-2:2009, heat and moisture exchangers, HMEs, tracheostomized patients, humidifying respired gases, medical device standards, ISO 9360.
