IEC 60601-2-34:2000 pdf download-Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment.
44.6 Ingress of liquids Replacement: TRANSDUCERS and EQUIPMENT parts containing insulation, the failure of which could result in a safety hazard or changes in essential aspects of performance according to this standard, and which in NORMAL USE are subject to immersion in liquids, shall be watertight according to IPX7 of IEC 60529. Connectors are excluded from this requirement. After the test all requirements of this Particular Standard shall be satisfied. The test need not be performed if examination of the construction and circuit arrangement shows that no safety hazard is possible. 45 Pressure vessel and parts subject to pressure This part of the General Standard applies except as follows: *45.1 01 Additional subclause a) Pressure above atmospheric The TRANSDUCER with reusable and/or disposable DOME , if applicable, shall withstand a pressure of 500 kPa (4 000 mm Hg) above standard atmospheric pressure applied gradually over approximately 1 /2 s and held for approximately 1 s. The test shall be as in Figure 107 and shall be repeated once within 10 s. The requirements of this test do not apply to CATHETER TIP TRANSDUCERS . b) Pressures below atmospheric The TRANSDUCER , with reusable and/or disposable DOME , if applicable, shall withstand a pressure of 50 kPa (400 mm Hg) below standard atmospheric pressure, applied gradually over approximately 0,5 s and held for approximately 1 s. The test shall be as in Figure 107 and shall be repeated once within 10 s. After these tests the requirements of this Particular Standard shall be satisfied (see 4.11). The requirements of this test do not apply to CATHETER TIP TRANSDUCERS . 46 Human errors *46.1 01 Additional subclause The DOME shall be transparent.
51 Protection against hazardous output This clause of the General Standard applies except as follows: Addition: *51 .1 01 Recovery time following a defibrillator discharge After the discharge of a cardiac defibrillator, the EQUIPMENT shall function within 1 0 s. Compliance shall be checked by applying a test pressure to the TRANSDUCER sufficient to produce 30 % to 70 % of full-scale deflection (output) at any NOMINAL SENSITIVITY . While the pressure is maintained, the EQUIPMENT is subjected to a test discharge. Figure 102 shall be used as the test arrangement under the following conditions: CLASS I EQUIPMENT – The PROTECTIVE EARTH TERMINAL and any FUNCTIONAL EARTH TERMINAL shall be connected to the PROTECTIVE EARTH TERMINAL of the test circuit. CLASS II EQUIPMENT and INTERNALLY POWERED EQUIPMENT – Foil and any ACCESSIBLE CONDUCTIVE PART not connected to FUNCTIONAL EARTH TERMINAL and any FUNCTIONAL EARTH TERMINAL shall be connected to the PROTECTIVE EARTH TERMINAL of the test circuit.