ISO 9360 Anaesthesia and Respiratory Equipment - Heat and Moisture Exchangers (HMEs) for Humidifying Inspired Gases in Humans

The “ISO 9360 Anaesthesia and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying human inspired gases” standard, developed by the International Standards Organization (ISO), consists of the following subsections published under the same title:

• The standard “ISO 9360-1 Part 1: HMEs for use with minimum tidal volumes of 250 ml” specifies specific requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, designed primarily for humidification of inspired gases for use in patients with a tidal volume of 250 ml or greater, and describes test methods for their evaluation.

For the purposes of this standard, the following definitions apply in addition to the terms and definitions given in ISO 4135:

• Heat and moisture exchanger is designed to retain some of the moisture and heat that the patient breathes out and return it to the airways during inhalation. is a heat and moisture exchanger device.
• Heat and moisture exchanger device port is the port that connects to the patient connection port of the respiratory system of this device.
• The heat and moisture exchanger patient port is the port of this device that connects to the patient's respiratory tract.
• The heat and moisture exchanger accessory port is the port of this device that can be connected to an accessory device. For example, an accessory device can be a gas sampling line, for example.
• The internal volume of the heat and moisture exchanger device is the volume contained in this device when it is unpressurized, minus the volume of all solid elements inside this device, minus the volume inside all female connectors.
• Heat and moisture exchanger device moisture loss is the total amount of water lost from the test device when tested in accordance with this standard.
• Pressure drop is the difference between the pressure measured in a gas stream flowing into the device and the pressure measured in a gas stream flowing through the device at a given continuous gas flow rate.

The heat and humidity exchanger device patient port connector is the connector on the patient port and should be a 5356 mm female conical connector or a 1 mm female or 15 mm male coaxial connector in accordance with the ISO 15-22 standard.

Connectors on other ports designed to accept breathing apparatus should be 5356 mm male or 1 mm conical connectors as specified in ISO 15-22.

If the heat and moisture exchanger device includes an accessory port, this port will not accept the 5356 mm or 1 mm connectors specified in the ISO 5356-2 or ISO 15-22 standard.

Heat and moisture exchanger devices supplied sterile must comply with the requirements specified in the ISO 11607 standard.

The apparatus and test methods specified in this standard are not intended to exclude the use of other measuring devices or methods that give results of equal or greater accuracy than those specified. In the event of a dispute, the methods given in this standard shall be the reference method. The tests are carried out at a temperature of 23 degrees plus/minus 2 degrees, a relative humidity of 50 percent plus/minus 20 percent, and an atmospheric pressure of 86 kPa to 106 kPa.

• The standard “ISO 9360-2 Part 2: HMEs for use in tracheostomized patients with a minimum tidal volume of 250 ml” is based on the ISO 9360-1 standard and specifies specific requirements and test methods for heat and moisture exchangers without machine attachment points, including those incorporating breathing system filters. These devices are intended for humidification of inspired gases for tracheostomized patients with a tidal volume of 250 ml or more.

For the purposes of this standard, in addition to the terms and definitions given in ISO 4135 and ISO 9360-1 standards, the following definition applies: A heat and moisture exchanger is the volume, when not under pressure, of a hypothetical boundary surface consisting of the inner surface of the impermeable material of the device, the minimum surface area surrounding the active element of the device, the volume of all solid elements within the device, and the volume of all female connectors within the device.

The heat and moisture exchanger patient port connector shall mate with a 5356 mm male connector conforming to ISO 1-15. Connectors on other ports designed to accept breathing apparatus shall be 5356 mm male or 1 mm conical connectors as specified in ISO 15-22. If the heat and moisture exchanger includes an accessory port, this port shall not accept the 5356 mm or 1 mm connectors specified in ISO 5356-2 or ISO 15-22. Heat and moisture exchanger devices supplied sterile shall comply with the requirements specified in ISO 11607.

The apparatus and test methods specified in this standard are not intended to exclude the use of other measuring devices or methods that give results of equal or greater accuracy than those specified. In the event of a dispute, the methods given in this standard shall be the reference methods. The tests are carried out at a temperature of 23 degrees plus/minus 2 degrees, a relative humidity of 50 percent plus/minus 20 percent, and an atmospheric pressure of 86 kPa to 106 kPa.

• The standard “ISO 9360-3 Part 3: Measurement of filtration performance” is still under development.

Our organization, which has been trying to support businesses from every sector with its wide range of testing, measurement, analysis and evaluation studies for years, has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. In this context, testing services are also provided to businesses in accordance with the "ISO 9360 Anesthesia and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying inhaled gases in humans" standard.