ISO 09360-1 pdf download – Anaesthetic and respiratory equipment—Heat and moisture exchangers (HMEs) forhumidifying respired gases in humans —Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 09360-1 pdf download – Anaesthetic and respiratory equipment—Heat and moisture exchangers (HMEs) forhumidifying respired gases in humans —Part 1: HMEs for use with minimum tidal volumes of 250 ml.
If the HME incorporates an accessory port, that port shall not accept the 15 mm or 22mm connectors specified in
ISO 5356-1 er ISO 5356-2.
5.3 Packaging of sterile HME
HUE supplied sterile shall comply with the recpjirements specified in Iso 11607.
6 Test methods
6.1 General
The apparatus and test methods specihed in 6.2 to o.5 are not intendea to exciude the uv vi VIJIeF i.ieuur,ig devices or methods yielding results of an accuracy equal to or greater than those specified. In the case of a depute, the methods given in this part ol ISO 9360 shall be the reference methods.
The tests shall be performed at a temperature of 23 C ±2 ‘.C. a RH of 50% ± 20%. and an atmospheric pressure of86kPato lO6kPa.
6.2 Measurement of moisture loss
6.2.1 Principle
The performance of ati HUE shall be measured by recording the mass of water lost from the test apparatus speafied In 6.22.
6.2.2 Test apparatus
The test apparatus (Figure 1) shall comprise the following components.
6.2.2.1 BIdirectional flow generator
This is a mechanicaJly-driveri piston used to produce a flow having sinuseldal waveform.
6.22.2 Humidity generator (HG), consisting of
a) a heated water bath (Figure 2) through which air is bubbled in both directions;
b) a rigid cylindrical reservoir (Figure 3) with a maximum volume of 71 and a diameter of approximately 150 mm, containing a 2 I reservoir bag:
C) a thermally insulated chamber (Figure 4). which contains the water bath, the reservoar and a heat source.
6.2.2.3 AIr delivery system (FIgure 5). consIsting of a T-pece with an Internal diameter greater than 15 mm, and an exhaust lube at least 200 mm in length.
6.2.2.4 Weaghing equipment, with an accuracy of t 0.1 g Or better in the range of the mass to be measured.
6.2.2.5 Flowrate measuring equipment. with an accuracy of at lesst 5% of the reading.
6.22.6 Calibration HME (Figure 6) consisting of a housing containing 81 polyvinyl chloride (PVC) tubes arranged In a 9’. 9 array. each with an internal diameter of 2 mm, an external diameter of 4 mm. and a length of 50mm.
When the apparalus has been constructed and operated as specified in 6.2.2, the rnoesture loss from the humidity generator with the caltxalion HUE will be as shown In Table 3.
6.2.3 Test conditions
6.2.3.1 The air delivered to the HUE machine pod by the air delivery system shall be at a temperature of
23 C ± 1 °C and shall have a humidity not exceedIng 1 mgi-1.
6.2.3.2 The HUE shall be tested at those conditions speclfied in Table 2 which are within the range specified for the HUE by the manufacturer, at the maximum tidal volume recommended by the manufacturer if this value is greater than ii, at a frequency ottO breathsmln-1. and an l:E ratio 041:1
6.2.4 Procedure
6.2.4.1 Connect the HG to the bidirectional flow generator.
6.2.4.2 Acust the bidirectional flow generator to give one of the test conditions in Table 2, measured at the machine port of the HUE, within the operating range of the HME as specified by the manufacturer. Adpust the flowrate of air delivered by the air delivery system to be between >1 and ci .5 times the peak ftowrate of air drawn into the machine port of the HME. The peak fiowrate is stated in Table 2.
6.2.4.3 Operate the test apparatus with an HME of the same type that is to be tested for a minimum of 1 h. with the water bath at a temperature 04 37 C ± 0.5 C, and the air within the insulated chamber at temperature of 37 Oc ± 1 °C. Maintain thés temperature for the duration 01 the test procedure.
6.2.4.4 Confirm that the volume of air leaving the machine port of the HUE is that required for the test condition chosen from Table 2.
6.2.4.5 Record the mass of the HG only (I.e. not including the HUE) (me).
6.2.4.6 Replace the HUE with the one to be tested and operate the test apparatus for (60±5) mm.