ANSI AAMI ISO 18241 pdf free download
ANSI AAMI ISO 18241 pdf free download.Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps.
4.3.2 Air removal efficiency
When tested in accordance with 5.4.2, the air removal efficiency shall be as expressed as a percentage. The manufacturer should specify the air challenge conditions. The test methodology should account for and measure gaseous microemboli for size and number and a second measurement of gross air volume.
4.3.3 Flow rate capacity
When tested in accordance with 5.4.3, the test results shall demonstrate the flow rate and pressure limitation(s), as specified by the manufacturer.
4.3.4 Shelf life
When tested in accordance with 5.4.4, the test results shall 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 in its terminally sterilized form and 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 °C ± 1 °C.
5.1.4 If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data points.
5.1.5 The test or measurement procedures shall be regarded as reference procedures. Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision.
5.2 Biological characteristics
5.2.1 SterIlity and non-pyrogeniclty
Compliance shall be verified by inspection of the manufacturer’s documentation on sterilization and pyrogen testing, in accordance with ISO 10993-11, ISO 11135-1, ISO 11137-1, ISO 14937 or ISO 17665-1, as applicable.
5.2.2 Biocompatibility
Compliance shall be verified by test or by inspection of the manufacturer’s documentation on biocompatibility for the
finished device, in accordance with ISO 10993-1 and ISO 10993-7, as applicable.
5.3 Physical characteristics
5.3.1 Blood pathway integrity
Fill the blood pathway of the device with water and subject it to a negative pressure of 1.5 x the manufacturer’s rated negative pressure and maintain the pressure for 6 h or for the intended time of use specified by the manufacturer. Visually inspect the device for evidence of air entrainment.
5.4 Performance characteristics 5.4.1 Blood cell damage 5.4.1.1.1 Test liquid The test liquid for the blood pathway shall be anticoagulated whole blood. 5.4.1.1.2 Procedure 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 means of controlling temperature, shall be assembled. The device under test shall be placed in one of the circuits between the inflow of a blood pump and the outlet of a patient simulating reservoir per the manufacturer ‘s instructions for use. 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. If the instructions for use call for connection to ancillary devices, these should be connected and operated at the worst case conditions allowed per the manufacturer’s instructions for use. A sufficient number of paired tests should be performed to support a statistical analysis. The predicate venous bubble trap should be tested under the same conditions. Compliance shall be verified by test or by inspection of the manufacturer ‘s documentation on blood cell damage for the finished device, in accordance with ISO 10993-4, as applicable.
ANSI AAMI ISO 18241 pdf download.
