ISO 9360-2:2001

Overview

ISO 9360-2:2001 specifies requirements and test methods for heat and moisture exchangers (HMEs) intended to humidify respired gases for tracheostomized patients with minimum tidal volumes of 250 ml. This part covers HMEs without machine connector ports (may incorporate breathing system filters) and defines performance testing, marking, labelling and packaging requirements relevant to manufacturers, test laboratories and clinical users.

Keywords: ISO 9360-2, heat and moisture exchanger, HME, tracheostomized patients, humidifying respired gases, medical device testing

Key topics and technical requirements

• Scope and device type
  • HMEs for tracheostomized patients with tidal volumes ≥ 250 ml; devices without machine connector ports.
• Connector compatibility
  • Patient port must mate with a 15 mm male connector complying with ISO 5356‑1. Other breathing attachments use 15 mm male and/or 22 mm conical connectors.
• Performance tests
  • Moisture loss measurement: uses a bidirectional flow generator and a humidity generator (heated water bath, reservoir and insulated chamber). Tests run at 37 °C conditioning and record mass loss of the humidity generator to calculate moisture loss (mg water per litre of air).
  • Pressure drop measurement: differential pressure across the HME measured at specified flow rates, before and after preconditioning.
  • Test environment: ambient 23 °C ±2 °C, 50 % ±20 % RH, atmospheric pressure 86–106 kPa. Typical respiratory test settings include 10 breaths/min and I:E = 1:1.
  • A calibration HME (PVC tube array) is specified for apparatus verification.
• Marking, labelling and packaging
  • Orientation marking (if orientation‑sensitive), APG marking for use with flammable anaesthetics, sterile labelling per ISO 11607, single‑use indication (or ISO 7000 symbol).
  • Manufacturer must supply performance data: recommended tidal volume range, moisture loss (mg/L at stated test conditions), pressure drop values, internal volume, recommended maximum time of use, reuse/sterilization instructions (if applicable), and disposal guidance.

Applications and users

• Intended audience:
  • HME manufacturers for product design and compliance testing.
  • Medical device test laboratories performing performance verification and type testing.
  • Regulatory authorities, procurement teams and clinical engineers assessing device specifications for tracheostomized patients.
  • Clinicians seeking objective performance data (moisture delivery and resistance) to inform device selection.
• Practical value: ensures consistent humidification performance, device compatibility with breathing circuits, predictable pressure drop characteristics, and clear labelling for safe clinical use.

Related standards

• ISO 9360‑1:2000 (general HME requirements)
• ISO 4135 (vocabulary)
• ISO 5356‑1 (conical connectors)
• ISO 7000 (graphical symbols)
• ISO 11607 (packaging for terminally sterilized medical devices)

This standard supports safe, interoperable HME design and reliable performance data for humidifying respired gases in tracheostomized patients.