Developed by the International Organization for Standardization (ISO), this part of ISO 9360 is based on ISO 9360-1 and specifies specific requirements and test methods for heat and moisture exchangers (HMEs) without machine attachment points, including those with breathing system filters. determines. These devices are designed for humidification of inhaled gases in tracheostomy patients with a tidal volume of 250 ml or more.
There are differences between heat and moisture exchange equipment. As such, different tests give different results. Therefore, the results of laboratory tests should be reinterpreted in a clinical setting. Issues regarding minimum heat and humidity output and safety are still under discussion.
HME Inner Volume is the volume contained within the HME when not under pressure, minus the volume of the HME, consisting of the inner surface of the impermeable material of the HME and a hypothetical boundary surface surrounding the active element of the HME, minus all the solid elements within the HME, minus all female volume inside the connectors.
Connectors on other ports intended to accept breathing inserts, for example a Y-piece, if present, should be 5356mm male and 1mm conical connectors as specified in ISO 15-2.
If the HME has an accessory port, this port will not accept 5356mm or 1mm connectors specified in ISO 5356-2 or ISO15-22.
The apparatus and test methods are not intended to exclude the use of other measuring instruments or methods that produce results of equal or greater accuracy than those specified. In the event of a dispute, the methods given in this part of ISO 9360 will be the reference methods.
The tests shall be carried out at 23 °C ± 2 °C, 50% ± 20% relative humidity and an atmospheric pressure of 86 kPa to 106 kPa.
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