MEDICAL DEVICES

Selection of tests for interactions with blood 10993-4

Tests to be performed in accordance with ISO
10993-4 Standard
• According to the 10993-4 ISO standard following tests can be
performed for external communicating devices:
• Thrombosis and Hematology Test for Blood Monitors
• Coagulation, platelets and hematology test for Blood storage and
administration equipment, blood collection devices and extension
sets.
• Coagulation, platelets, hematology, complement system and
thrombosis test for Hemodialysis, hemofiltration equipment and
percutaneous circulatory support device
Tests to be performed in accordance with ISO
10993-4 Standard
• Coagulation, hematology and thrombosis test for Catheters,
guidewires, intravascular endoscopes, intravascular ultrasound,
laser systems and retrograde coronary perfusion catheters.
• Coagulation, platelets, hematology and complement system test for
Devices for absorption of specific substances from blood.
• Coagulation, platelets, hematology and complement system test for
Donor and therapeutic apheresis equipment.
Tests to be performed in accordance with ISO
10993-4 Standard
• IMPLANT DEVICES
• Thrombosis and hematology test for Annuloplasty rings and
mechanical heart valves.
• Coagulation, platelets, hematology, complement system and
thrombosis test for Intra aortic balloon pumps.
Tests to be performed in accordance with ISO
10993-4 Standard
• Evaluation methods for Thrombosis
Percent Occlusion
Flow Reduction
Gravimetric analysis
Light Microscopy
Pressure drop across device
Antibodies labelling
Scanning EM
Tests to be performed in accordance with ISO
10993-4 Standard
Evaluation methods for Coagulation
PTT (non-activated)
Thrombin generation
Evaluation methods for Platelets
Platelet count/adhesion
Platelet aggregation
Template bleeding time
Platelet function analysis
Platelet activation markers
Tests to be performed in accordance with ISO
10993-4 Standard
Evaluation methods for Platelets
Platelet count/adhesion
Platelet aggregation
Template bleeding time
Platelet function analysis
PF-4, thromboxane B2
Platelet activation markers
Platelet microparticles
Tests to be performed in accordance with ISO
10993-4 Standard
Evaluation methods for Hematology
Leukocyte count with or without differential, leukocyte activation,
hemolysis, reticulocyte count
Evaluation methods for Complement system
C3a, C5a, TCC, Bb, iC3b, C4d, 5C5b-9, CH50, C3 convertase, C5
convertase
Tests to be performed in accordance with ISO
10993-4 Standard
Implant devices Evaluation methods for Thrombosis
Scanning EM
Percent Occlusion
Flow Reduction
Autopsy of devices
Autopsy of distal organs
Evaluation methods for Coagulation
Specific coagulation Factor Assay
Tests to be performed in accordance with ISO
10993-4 Standard
Evaluation methods for Hematology
Leukocyte count
Leukocyte activation
Hemolysis
Reticulocyte count
Evaluation methods for Complement System
C3a, C5a etc.