IEC 60601-2-34:2000 pdf free download – Medical electrical equipment
The same test pressure as before is applied again to the TRANSDUCER.The deflection shall bethe same as that noted at the beginning of this test, the tolerance allowed by the specificationin the AcCOMPANYING DoCUMENTS.
lf the EQUIPMENT forms part of a medical electrical system,then the system and theEQUIPMENT shall not be subjected to the above test,unless the EQUIPMENT or part of theEQUIPMENT is separable from the system while remaining functional, in which case the saidEQUIPMENT or parts of the EQUIPMENT shall be subjected to the above test.
44.6 Ingress of liquids
Replacement:
TRANSDUCERs and EQUIPMENT parts containing insulation, the failure of which could result in asafety hazard or changes in essential aspects of performance according to this standard,andwhich in NORMAL USE are subject to immersion in liquids,shall be watertight according to lPX7of lEC 60529.Connectors are excluded from this requirement.After the test all requirementsof this Particular Standard shall be satisfied.The test need not be performed if examination ofthe construction and circuit arrangement shows that no safety hazard is possible.
Energize the EQUIPMENT.
1)Equilibrate the TRANSDUCER and EQUIPMENT at 25 °C ± 1 °C for 2 h.The TRANSDUCER and its hydraulic parts are filled with water.
2)Balance the TRANSDUCER to obtain zero pressure output with zero pressure input. Note the barometric pressure.
3)Using a pressure source referenced to atmospheric pressure with a combined non-linearity and hysteresis error of ±0,1 % of full scale，apply pressures as a percentage ofthe largest full-scale pressure range of 0,10，20，50，80，100,80，50，20，10,0,-10,-15,and 0 %.The output pressure shall be within ±4 % of reading or ±0,5 kPa (±4 mm Hg),whichever is greater,compared to the reference measurement.
4) Equilibrate the TRANSDUcER and EQUIPMENT for 2 h at 15 °C± 1°C.Apply pressure as in 3). Note the barometric pressure and apply correction prior to determining compliance.
5) Equilibrate the TRANSDUCER and EQUIPMENT for 2 h at 25 C ± 1°C.Apply pressure as
in 3).Note the barometric pressure and apply correction prior to determining compliance.
6)Equilibrate the TRANSDUCER and EQUIPMENT for 2 h at 35 C ± 1°C.Apply pressure asin 3).Note the barometric pressure and apply correction prior to determining compliance.7)Equilibrate the TRANSDUCER and EQUIPMENT for 2 h at 25 °C ± 1°C.Apply pressure as in 3). Note the barometric pressure and apply correction prior to determining compliance.For CATHETER TIP TRANSDUCERs (see Figure 113 for test sequence)
51.203.1NON-LATCHED ALARM(s)
lf EQUIPMENT is equipped with NON-LATCHED ALARM(s)，the ALARM(s) shall be sILENCED andRESET automatically (without any OPERATOR interaction) as soon as the monitoredparameter(s) come(s) back within the adjusted limits,or if the abnormal PATIENT conditiondoes not exist any longer.
Compliance testing for NON-LATCHED ALARM(S).
A PHYSIOLOGICAL ALARM is simulated. As soon as the visual and auditory ALARM devicesindicate the ALARM,the simulator settings are changed to a value that no longer exceeds thealarm limit.When the monitored parameter returns to a value that no longer exceeds theALARM limit, the auditory or the auditory and visual ALARM manifestations shall cease withoutactivating the function SILENCE/RESET.