BS EN ISO 7199 2017 pdf free download.Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) (ISO 7199:2016)
5.3 Physical characteristics
5.3.1 Blood pathway integrity
5.3.1.1 Test liquid
The test liquid shall be water.
5.3.1.2 Procedure
Place the device under test in an appropriate test circuit. Subject the blood pathway of the device to a pressure that is 1,5 × the maximum pressure specified by the manufacturer for intended clinical use.
If no maximum pressure is specified, the test shall be performed at 152 kPa for 6 h or as long as it is specified by the manufacturer for clinical use. Visually inspect the device for leakage of water.
5.3.2 Heat exchanger water pathway integrity
5.3.2.1 Test liquid
The test liquid shall be water.
5.3.2.2 Procedure
Place the device under test in an appropriate test circuit. Subject the heat exchanger fluid pathway to a pressure 1,5 × that specified by the manufacturer for intended clinical use. If no maximum pressure is specified, the test shall be performed at 350 kPa. Maintain this pressure for 6 h or as long as is specified by the manufacturer for intended clinical use and visually inspect the device for leakage of water.
5.3.3 Blood volumes
5.3.3.1 Test liquid
The test liquid shall be anticoagulated whole blood or water.
5.3.3.2 Procedure
The volume of the blood pathway shall be determined over the range of operating variables specified by the manufacturer for intended clinical use (see 6.3).
5.3.3.3 Residual blood volume
Residual blood volume is determined by holding the unit in its most advantageous drainage position for 20 s past the time that air first appears at the port being used for drainage until no remaining volume is noted in the device.
5.3.4 Connectors
The connection shall be made in accordance with the manufacturer’s instructions for use.
The connection shall withstand a pull force of 15 N for 15 s without separating.
5.4 Performance characteristics
5.4.1 Oxygen and carbon dioxide transfer rates
5.4.1.1 Test media
The test liquid for the blood pathway shall be anticoagulated blood. The test medium for the gas pathway shall be gas of known oxygen, nitrogen and carbon dioxide concentrations.
5.4.1.2 Procedure
5.4.1.2.1 General
Place the device under test in an appropriate test circuit. Perform tests using the following blood inlet conditions during determination of oxygen and carbon dioxide transfer rates:
— oxyhaemoglobin percentage: (65 ± 5);
— haemoglobin: (12 ± 1) g/dl;
— base: (0 ± 5) mmol/l;
— partial pressure of carbon dioxide in blood, p CO2 : (6,0 ± 0,7) kPa.
Oxygen and carbon dioxide transfer rates shall be determined over the manufacturer’s specified range of operating variables (see 6.3).
Between each set of measurements, the blood flow shall be kept at the maximum specified by the manufacturer for intended clinical use (see 6.3).
Determination of oxygen and carbon dioxide transfer rates shall be made at the initiation of the test.
For dependent determinations, measurements shall be performed at initiation of the test and then at 1 h, 3 h and 6 h after the start of the test. As applicable, further determinations shall be made at 6 h intervals.
In vitro tests as well as tests using an appropriate animal model are acceptable.
The blood may be exchanged for fresh blood as required in oxygen and carbon dioxide transfer measurements.
Data need not be collected at the precise conditions specified. Approximations obtained by reasonable interpolation are acceptable.
5.4.1.2.2 Clinical conditions
For additional information, the following test conditions should be considered.
Place the device under test in an appropriate test circuit. Perform tests using the following blood inlet conditions during determination of oxygen and carbon dioxide transfer rates:
— change temperature to a range 28 °C and 18 °C ± 1 °C
— oxyhaemoglobin percentage: (65 ± 5);
— haemoglobin: (8 ± 2) g/dl;
— base: (0 ± 5) mmol/l;
— partial pressure of carbon dioxide in blood, p CO2 : (6,0 ± 0,7) kPa.
5.4.2 Heat exchanger performance factor
5.4.2.1 Test liquid
The test liquid for the blood pathway shall be anticoagulated blood or water.
5.4.2.2 Procedure
Place the device under test in an appropriate test circuit. Perform the test in vitro under the following
conditions:
— blood inlet temperature, T in,blood : (30 ± 1) °C;
— water inlet temperature, T in,water : (40 ± 1) °C.
The determination of heat exchanger performance factors shall be made over the manufacturer’s specified range of operating variables (see 6.3).BS EN ISO 7199 pdf download