ISO 9360-1:2000

Overview

ISO 9360-1:2000 defines performance and test requirements for heat and moisture exchangers (HMEs) used to humidify respired gases in humans for patients with minimum tidal volumes of 250 ml. Part 1 of ISO 9360 covers HMEs intended to be used with breathing systems (including machine ports), describes laboratory test methods (moisture loss, pressure drop, leakage, compliance), and specifies marking and connector requirements. This standard is essential for manufacturers, test laboratories, clinical engineers and procurement teams working with anaesthetic and respiratory equipment.

Key Topics and Requirements

• Device purpose and scope: HMEs retain expired moisture/heat and return it during inspiration; intended for patients with tidal volume ≥ 250 ml.
• Connectors: Patient port must be a 15 mm female conical or 15 mm female / 22 mm male coaxial connector complying with ISO 5356-1. Other breathing attachment ports must use 15 mm/22 mm connectors per ISO 5356-1; accessory ports must not accept those standard connectors.
• Sterile packaging: HMEs supplied sterile must comply with ISO 11607 packaging requirements.
• Test environment: Tests referenced in the standard are to be performed at 23 °C ± 2 °C, relative humidity 50 % ± 20 %, and atmospheric pressure 86–106 kPa.
• Key test methods:
  • Moisture loss measurement - using a bidirectional flow (sinusoidal) generator and a humidity generator (heated water bath, reservoir, insulated chamber). Moisture loss is calculated from mass change of the humidity generator per litre of ventilated air; calibration HME and defined test conditions (tidal volumes 1 000 / 750 / 500 / 250 ml with specified frequencies and peak flows) are described.
  • Pressure drop, gas leakage, and compliance tests are specified (methods summarized in Clauses 6.3–6.5).
• Marking and documentation: Requirements for identification, intended use, and maximum recommended time of use.

Applications and Who Uses This Standard

• Manufacturers of HMEs and breathing system filters - design verification, type testing, and product documentation.
• Independent test laboratories - reference methods for moisture loss, pressure-drop and leakage testing.
• Clinical engineers / biomedical departments - evaluating compatibility with ventilators and breathing circuits.
• Hospitals and procurement - comparing product performance (humidification efficiency, resistance) for ventilation and anaesthesia.
• Regulators and conformity assessors - assessing compliance for medical device clearance and quality systems.

Related Standards

• ISO 9360-2 (HMEs for tracheostomized patients)
• ISO 5356-1 / ISO 5356-2 (conical connectors)
• ISO 4135 (anaesthesiology vocabulary)
• ISO 11607 (sterile medical device packaging)
• IEC 60601-1 (medical electrical equipment – general safety)

Keywords: ISO 9360-1, heat and moisture exchanger, HME, humidifying respired gases, tidal volume 250 ml, anaesthetic and respiratory equipment, moisture loss test, pressure drop, ISO 5356, ISO 11607.