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In-vivo Thrombogenicity Test

In-vivo Thrombogenicity Test

The In-vivo Thrombogenicity test determines a comparative thromboresistent for medical devices that are intended for blood contact. This test enables manufacturers to see if the medical devices cause any potentially undesirable effects on humans, such as activation of platelets, formation of a thrombus, embolism or injury to cells. This test complies with ISO 10993-4.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ISO 10993

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SCX670 Hemocompatibility: Dog Thrombogenicity 42 Add
SCX680 Hemocompatibility: Pig Thrombogenicity 42 Add
SCX690 Hemocompatibility: Sheep Thrombogenicity 42 Add
SCX670 - Hemocompatibility: Dog Thrombogenicity
TAT: 42 days
SCX680 - Hemocompatibility: Pig Thrombogenicity
TAT: 42 days
SCX690 - Hemocompatibility: Sheep Thrombogenicity
TAT: 42 days

Sample Specifications

SCX670: 4 test devices and 4 predicates. CSS Approval is needed to meet TAT.
SCX680: 2 test devices and 2 predicates. CSS Approval is needed to meet TAT.
SCX690: 2 test devices and 2 predicates. CSS Approval is needed to meet TAT.

Study Outline

The In-vivo Thrombogenicity test generates safety data for a blood contacting device. While in use, blood contacting medical device interactions may have potentially undesirable effects on humans. This test is designed to determine the comparative thromboresistance of a medical device intended for blood contact by implanting the test article in the venous system of a canine study model. Its performance is then compared to an appropriate negative control device.
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