ISO 7199:2016 pdf free
ISO 7199:2016 pdf free.Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
Two sets of appropriate, identical circuit components, including a pump, connecting tubing, a reservoir (as specified by the manufacturer and of suitable size relative to the device under test) and a heat exchanger, shall be assembled. The device under test shall be placed in one of the circuits. A predicate device shall be placed in the second test circuit. Priming and debubbling of the circuits by recirculating with an appropriate solution is recommended before blood is added. The blood pathway test-liquid volumes shall, at the initiation of the test, be within 1 % of each other. Perform the test in vitro using the conditions given in Table 1. A sufficient number of paired tests should be performed to support a statistical analysis. The predicate oxygenator should be tested under the same conditions.
The sampling schedule shall be in accordance with Table 2. More frequent sampling times are optional.
Use filter vent tubing as specified in the manufacturer’s instructions for use. The length and internal diameter of the vent tubing shall be specified. The back pressure at the maximum test flow shall be 26,6 kPa (3,9 psi)±5 %. Use a bubble eliminator to measure any air downstream of the integral filter accumulated over a period of 5 min from bolus injection. At flow rates of 33 %, 67 %，and 100 % of the specified maximum rated flow rate, a bolus of 30 ml of room air for adult oxygenators (for paediatric or infant oxygenators with a maximum flow rate of less than 500 ml/min the bolus shall be 2,5 ml and for maximum flow rates higher than 500 ml/min the bolus shall be increased by 2,5 ml for every 500 ml/min maximum flow rate; the maximum bolus shall be 10 ml) shall be injected as a single bolus.Indication of the air bolus injection point in the test circuit, rate of injection, and type of pump utilized to circulate test liquid should be provided in the test protocol.ISO 7199 pdf free download.
