Hemocompatibility, Hemolysis
Hemocompatibilitly test for compatibility for all devices that come in contact with circulating blood, either directly or indirectly. Depending on the type of contact the device has with blood and clinical concerns determines the type of hemocompatibility that is suggested by ISO 10993-4.
Optional Tests for Hemocompatibility, Hemolysis
Dog thrombogenicity ISO 10993
Hemocompatibility complement activation C3a only ISO 10993-4
Partial Thromboplastin Time (PTT) Human plasma ANSI/AAMI/ISO 10993-4
The partial thromboplastin time (PTT) is a general screening test for the detection of coagulation abnormalities in the intrinsic pathway. This assay was developed from the plasma re-calcification time by the addition of non-activated PTT reagent to a suspension of rabbit brain cephalin.
Hemolysis evaluation ASTM hemolysis direct contact, device/material (human blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The procedure is used to determine the hemolytic properties of a test sample which contacts blood. The test procedure is run under static conditions. The amount of hemoglobin released by the sample is measured spectrophotometrically at 540 nm concurrently with the negative and positive controls.
Hemolysis evaluation ASTM hemolysis extract, device/material (human blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The procedure is used to determine the hemolytic properties of a test sample which contacts blood. The test procedure is run under static conditions. The amount of hemoglobin released by the sample is measured spectrophotometrically at 540 nm concurrently with the negative and positive controls.
Hemolysis evaluation NIH hemolysis direct contact, device/material (human blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
Samples are placed in tubes, then saline and citrated blood are added. Tubes are incubated and the blood suspension is removed and centrifuged to cause separation of lysed and unlysed cells. The amount of cell lysis or released hemoglobin is then determined spectrophotometrically at a wavelength of 540 nm.
Hemolysis evaluation NIH hemolysis extract, device/material (human blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The samples are extracted in 0.9% saline and extracted at a temperature determined by the sponsor. After placement in citrated blood and centrifuged, the amount of cell lysis or released hemoglobin is then determined spectrophotometrically at a wavelength of 540 nm.
Hemolysis evaluation ASTM hemolysis direct contact, device/material (rabbit blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The procedure is used to determine the hemolytic properties of a test sample which contacts blood. The test procedure is run under static conditions. The amount of hemoglobin released by the sample is measured spectrophotometrically at 540 nm concurrently with the negative and positive controls.
Hemolysis evaluation ASTM hemolysis extract, device/material (rabbit blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The procedure is used to determine the hemolytic properties of a test sample which contacts blood. The test procedure is run under static conditions. The amount of hemoglobin released by the sample is measured spectrophotometrically at 540 nm concurrently with the negative and positive controls.
Hemolysis evaluation NIH hemolysis direct contact, device/material (rabbit blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
Samples are placed in tubes, then saline and citrated blood are added. Tubes are incubated and the blood suspension is removed and centrifuged to cause separation of lysed and unlysed cells. The amount of cell lysis or released hemoglobin is then determined spectrophotometrically at a wavelength of 540 nm.
Hemolysis evaluation NIH hemolysis extract, device/material (rabbit blood) ISO 10993-1, ISO 10993-4, ISO 10993-12
The samples are extracted in 0.9% saline and extracted at a temperature determined by the sponsor. After placement in citrated blood and centrifuged, the amount of cell lysis or released hemoglobin is then determined spectrophotometrically at a wavelength of 540 nm.
