BS EN ISO 7199:2017 pdf – Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) (ISO 7199:2016)

BS EN ISO 7199:2017 pdf – Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) (ISO 7199:2016).
4.2 Physical characteristics 4.2.1 Blood pathway integrity When tested in accordance with 5.3.1, the blood pathway shall not leak. 4.2.2 Heat exchanger fluid pathway integrity When tested in accordance with 5.3.2, the heat exchanger fluid pathway shall not leak. 4.2.3 Blood volumes When tested in accordance with 5.3.3, the volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3). 4.2.4 Connectors Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.4, allow a secure connection. NOTE 1 Connectors of a type that allows connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5 mm or 12,7 mm, or a type that complies with ISO 8637:2010, Figure 1, or a type that complies with ISO 594-2, have been found satisfactory. When tested in accordance with 5.3.4, the gas inlet connection to the gas pathway shall not separate. Connectors for the heat exchanger fluid pathway shall be capable of being connected using fast couplings. NOTE 2 Connectors corresponding to ISO 8637:2010, Figure 3 are considered as one way to comply with this requirement. 4.3 Performance characteristics 4.3.1 Oxygen and carbon dioxide transfer rates When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall be within the range of values specified by the manufacturer (see 6.3). 4.3.2 Heat exchanger performance factor When determined in accordance with 5.4.2, the heat exchanger performance factors shall be within the range of values specified by the manufacturer (see 6.3).
4.3.6 Blood cell damage 4.3.6.1 Plasma-free haemoglobin When determined in accordance with 5.4.3, the increased concentration of plasma-free haemoglobin shall be within the range of values specified by the manufacturer. The haemolysis results shall be reported as mg/dl and NIH. 4.3.6.2 Platelet reduction and white blood cell reduction When determined in accordance with 5.4.3, the percentage reduction of platelets and the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer. 4.3.7 Time-dependent performance changes When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall remain consistent within the range of values over the duration of the testing specified by the manufacturer. 4.3.8 Shelf life When tested in accordance with 5.4.4, test results should demonstrate the rated shelf life, as specified by the manufacturer. 5 Tests and measurements to determine compliance with this document 5.1 General 5.1.1 Tests and measurements shall be performed with the device under test prepared according to the manufacturer’s instructions for intended clinical use. 5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified. 5.1.3 Unless otherwise stated, the temperature of test liquids shall be (37 ± 1) °C. 5.1.4 If the relationship between variables is nonlinear, sufficient determinations shall be made to permit valid interpolation between data points. 5.1.5 The test or measurement procedures are to be regarded as reference procedures. Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision and reproducibility.
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).