ANSI AAMI ISO 18242 pdf free download
ANSI AAMI ISO 18242 pdf free download.Cardiovascular implants and extracorporeal systems- Centrifugal blood pumps.
5.4 Performance characteristics
5.4.1 Hydraulic performance
5.4.1.1 Test liquid
The test liquid shall be a blood analogue or anticoagulated blood, and its composition and viscosity (measured at the same temperature as the hydraulic performance testing) shall be indicated.
5.4.1.2 Procedure
Place the device under test in an appropriate test circuit. Perform the testing at 37 °C ± 1 °C or at typical temperature, viscosity, and hematocrit of blood during intended clinical use. Set the r/min of the pump. By varying the restriction on the outlet tubing, measure the pressure differential between the inlet and outlet and the corresponding flow rate. Construct a plot showing the pressure differential versus flow rate for multiple r/min settings over the entire rated operating range of the pump (up to the maximum r/min).
5.4.2 Blood cell damage
5.4.2.1 Test liquid
The test liquid shall be anticoagulated whole blood, and the method of collection and species should be described.
5.4.2.2 Procedure
Two sets of appropriate circuit components (including a pump in the test circuit and a predicate pump in the control circuit), connecting tubing, and a reservoir (as specified by the manufacturer and of suitable size relative to the device under test) shall be assembled. Priming and debubbling of the circuits by recirculating with an appropriate solution is recommended before blood is added. The test liquid volumes shall, at the initiation of the test, be within 1 % of each other. Perform the test using the maximum rated flow rate of the device and obtain blood samples at least at the following time points: prior to test, 30 mm, 180 mm, and 360 mm. More frequent sampling times are optional. For each sample, measure the following: plasma-free hemoglobin, white blood cell, platelet counts, activated clotting time, temperature, and flow rate. Glucose should also be measured prior to the test. A sufficient number of paired tests should be performed to support a statistical analysis. The predicate pump should be tested under the same conditions regarding flow rate, preload, and afterload.
4.3.2.1 Plasma-free hemoglobin
When determined in accordance with 5.4.2, the rate of generation of plasma-free hemoglobin shall be within the range of values specified by the manufacturer.
The hemolysis results shall be reported as mg/dL and NIH.
4.3.2.2 Platelet reduction
When determined in accordance with 5.4.2, the percentage reduction of platelets shall be within the range of values specified by the manufacturer.
4.3.2.3 White blood cell reduction
When determined in accordance with 5.4.2, the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer.
4.3.3 Bearing durability
When determined in accordance with 5.4.4, the bearing shall remain functional over the duration of the testing specified by the manufacturer, unless the device is bearingless.
4.3.4 Shelf life
When tested in accordance with 5.4.4, 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
Tests and measurements shall be performed with the device under test prepared according to the manufacturer’s instructions for intended clinical use and in accordance with the manufacturer’s specified test methodology.
5.1.2 Operating variables
Operating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.
5.1.3 Temperature
The temperature of the test liquid(s) shall be representative of a range of the intended temperatures during clinical use of the device (e.g. hypothermic, normothermic, and/or hyperthermic). Tests should be performed at multiple temperatures over the range of the intended clinical use, or justification for testing at a single temperature should be provided (e.g. why this temperature is representative of the worst case condition).
5.1.4 Relationship between variables
If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data points.
ANSI AAMI ISO 18242 pdf download.
