AAMI ISO 11195 pdf free download

AAMI ISO 11195 pdf free download.Gas mixers for medical use—Stand-alone gas mixers.
5 Normal operating conditions 5.1 Normal operating conditions shall be with the gas mixer connected to inlet gas supplies at all pressures and pressure differentials in the range stated by the manufacturer and at any setting of the mixer control with either flow or no-flow conditions. 5.2 The gas mixer shall have an auditory alarm to indicale thal the inlel pressure conditions are oulside the range of normal operating conditions specified by the manufacturer 「see 15.2 p)]. If electrically pow- ered, the alarm signal shall be a medium priority alarm complying with ISO 9703-2. NQTE 2 The gas mixer need not be provided with a high-pressure alarm if the upper limit of the input pressure specified by the manufacturer is higher than the normal maximum pressure provided by a medical gas pipeline. The maximum gas pressure which a medical gas pipeline con- forming with ISO 7396: 1987. Non-flammable medical gas pipeline systems, will deliver in normal use is proposed, in the forthcoming new edition, to be 600 kPa.6 Reverse gas flow 6.1 Means shall be provided so that the reverse flow of gas from each gas inlet to every other shall not exceed 10 ml/h (0.0169 kPa /min) under normal operating cunditions (I under any single fault con- dition which is not alarrned. Test according to A.3. 6.2 Means shall be provided so that the reverse gas flow from each gas inlet to every other shall not ex- ceed 100 ml/min (10.13 kPa l/min) during any single fault condition which is indicated by an alarm. Test according to A.3. 6.3 The manufacturer shall maintain documentation of methods by which compliance with 6.1 and 6.2 has been verified. together With data supporting the Val- idity of the methods.7 Inlet filter Each gas inlet shall be provided with a filter having pore size not excoeding 100 μm. 8 Flow controls For a rotary flow adjustment control, a counter- clockwise rotation shall cause an increase in flow and, conversely, a clockwise rotation shall cause a de- crease in flow. The stem of each rotary flow control valve shall be captive, s0 that it cannot bc discngaged from its housing without the use of tools. 9 Leakage to atmosphere Except for gas which is vented (bled) from the mixer by design, gas mixers shall not leak to atmosphere by more than 50 m/min (5,065 kPa /min) when tested according to A.4.10 Low-pressure flexible connecting hose assemblies All cxtcrnal, opcrator dctachablc inlct low-pressure hose assemblies supplied with the gas mixer shall comply with ISO 6359. 11 Accuracy of operating data 11.1 When tested according to A.2, the oxygen concentration of the delivered gas shall be Within 十5 % (VM of the indicated value. The tolerance shall not result in an oxygen concentration of less than 20 % (V/V. The accuracy requirement shall apply only to marked concentration values and nol between markings, unless otherwise stated by the manulac- turer. 11.2 When tested according to A.2, the gas mixer shall continue to function within the specified toler- ances throughout the range of input pressure variation stated by the manufacturer [see 15.2 a)].AAMI ISO 11195 pdf download.