ISO 8637:2010 pdf free download – Cardiovascular implants and extracorporeal systems一 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.
5.4 Non-pyrogenicity
Compliance with 4.3 shall be verified in accordance with ISO 10993-11.
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.1.1 General
The requirements of 4.4.1 shall be venfied by the following test methods.
5.5.1.2 Positive-pressure test
Completely fill the device with degassed water at (37 ± 1) °C. Seal all ports except the port to which pressure is applied. Apply a positive pressure 1,5 x the manufacturer’s recommended maximum pressure and seal the apparatus. After 10 mm, record the pressure and visually examine the device for leaks.
5.5.1.3 Negative pressure test
Completely fill the device with degassed water at (37 ± 1) °C. Seal all ports except the port to which pressure is applied. Put the device under sub-atmospheric pressure, 1,5 x the manufacturer’s recommended maximum pressure, unless that sub-atmospheric pressure exceeds 700 mmHg or is not specified; in that case, apply a sub-atmospheric pressure of 700 mmHg (93,3 kPa) and seal the apparatus. After 10 mm, record the pressure and visually examine the device for leaks.
5.5.2 Blood compartment integrity
Compliance shall be determined by review of the validation records for the test procedure.
5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
Compliance with 4.4.3 shall be determined by inspection. See Figure 1 and Figure 3.
5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
Compliance with 4.4.4 shall be determined by inspection. See Figure 2.
5.5.5 Haemofilter filtrate ports
Compliance with 4.4.5 shall be determined by inspection and shall meet the requirements of Figure 2 or the
requirements of ISO 594-2.
5.5.6 Haemoconcentrator blood and filtrate ports
Compliance with 4.4.6 shall be determined by inspection and shall not separate under an axial force of 15 N.
5.6.3 Ultrafiltration coefficient
5.6.3.1 Test solution
The test solution for haemodialysers, haemodiafilters and haemofilters shall be anticoagulated bovine or human blood, with a haematocrit of (32 ± 3) % and a protein content of (60 ± 5) gIl. For haemoconcentrators, a test solution of anticoagulated bovine or human blood, with a haematocrit of (25 ± 3) % and a protein content of (50 ± 5) gIl may be used.
No fluid is to perfuse the dialysis fluid or filtrate compartment.
5.6.3.2 Test procedure
Set up the test circuit as shown in Figure 5. Establish stable conditions (temperature, flow and pressure) for blood and filtrate flows and ensure all air is removed from the haemodiafilter, haemofilter or haemoconcentrator. Measure the ultrafiltration flow rate over the manufacturer’s specified range. Calculate the ultrafiltration coefficient as the slope of the regression line between filtration flow rate and transmembrane pressure, taking oncotic pressure into account.
NOTE The filtration flow rate is not a linear function of transmembrane pressure above some value of transmembrane pressure. Beyond that point, the filtration flow rate tends to reach a constant value, representing the maximum filtration flow rate for the device.
5.6.4 Volume of the blood compartment
For hollow-fibre devices, the cell volume can be calculated by utilizing the dimensions of the device and the number of fibres in the bundle. If the membrane is known to significantly change dimensions after wetting, the following alternative method should be used.
Alternately, fill the blood compartment with a fluid that is easily removable but that will not pass through the membrane. Measure the volume of the fluid needed to fill the blood compartment. Perform measurements over the specified range of transmembrane pressures. If the blood compartment is noncompliant, the measurement at a single pressure is acceptable.
5.6.5 Pressure drop of the blood compartment
5.6.5.1 General
Compliance with 4.5.5 shall be determined in accordance with the test described below.