Hemocompatibility Testing Services for Blood-Contacting Medical Devices

Hemocompatibility Testing

Alta Biomed provides hemocompatibility testing support for vascular and other blood-contacting medical devices using dynamic human blood flow loop models. Our testing can help device developers compare coated and uncoated devices, evaluate thrombus-related performance, assess blood-material interactions, and generate development-stage data to support ISO 10993-4-aligned biological evaluation planning.

Testing programs can be tailored to the device geometry, materials, blood-contacting surface, intended use, anticoagulation strategy, and development stage.

Discuss a Hemocompatibility Testing Program

Devices and Materials We Test

Alta Biomed supports hemocompatibility testing for vascular and blood-contacting devices, materials, and components, including:

  • Stents and covered stents

  • Vascular grafts and ePTFE grafts

  • Catheters and catheter-based devices

  • Blood filters and embolic protection devices

  • Nitinol frames and implants

  • PET / polyester vascular materials

  • Polymeric and metallic blood-contacting components

  • Coated and uncoated test articles

  • Representative coupons or finished devices

Whenever possible, testing should use the finished device or representative test articles that reflect the final blood-contacting surface, geometry, and manufacturing process.

What Hemocompatibility Testing Can Evaluate

Hemocompatibility testing evaluates how a device or material interacts with blood. Depending on the study design, device type, and development question, testing may evaluate endpoints related to:

  • Thrombus formation

  • Fibrin or protein deposition

  • Platelet adhesion, activation, or consumption

  • Coagulation-related response

  • Hemolysis or plasma-free hemoglobin

  • White blood cell or hematology changes

  • Complement-related endpoints

  • Surface deposition after blood exposure

  • Device-specific regions of thrombus accumulation

ISO 10993-4 addresses evaluation of interactions between medical devices and blood, including classification based on intended use and contact duration, fundamental principles for evaluating blood interactions, and rationale for structured test selection.

Coated vs. Uncoated Device Comparisons

For coating development programs, one of the most useful study designs is a direct comparison of coated and uncoated versions of the same device.

This approach can help answer questions such as:

  • Does the coating change thrombus accumulation compared with the uncoated device?

  • Does the coating reduce visible fibrin or protein deposition in the test model?

  • Are platelet-related endpoints different between coated and uncoated samples?

  • Are there specific device regions where thrombus still accumulates?

  • Does the coating remain intact after blood exposure?

  • Does the coating process affect the device material or geometry?

Coated vs. uncoated testing is especially useful during feasibility and process development because it helps isolate the effect of the surface modification while keeping device geometry and test conditions as consistent as possible.

Test Design and Study Outputs

Hemocompatibility testing should be designed around the device, intended use, blood contact duration, and development objective. Alta works with customers to define test conditions and outputs that are appropriate for the question being asked.

Study design considerations may include:

  • Device type and clinical use case

  • Blood-contacting surface area

  • Device geometry and flow path

  • Anticoagulant type and concentration

  • Flow rate and pulsatility

  • Exposure duration

  • Temperature

  • Number of donors and replicates

  • Coated, uncoated, and control groups

  • Endpoint selection

  • Imaging and documentation needs

Typical study outputs may include visual observations, endpoint data, comparative results, representative images, and a technical summary report.

Support for ISO 10993-4-Aligned Evaluation

ISO 10993-4 provides a framework for selecting tests to evaluate interactions between medical devices and blood. The appropriate test strategy depends on the device’s intended use, duration of blood contact, materials, geometry, and risk profile.

Alta’s hemocompatibility testing can support development-stage evaluation, coating comparisons, test method development, and ISO 10993-4-aligned biological evaluation planning. For regulatory submissions, test strategy should be determined based on the finished device, applicable standards, risk assessment, and regulatory expectations.

This wording is stronger and safer than implying that a single blood loop test automatically satisfies all ISO 10993-4 requirements.

Why Alta Biomed

Alta Biomed combines blood-contacting medical device coating expertise with dynamic human blood loop testing capabilities. This allows developers to evaluate not only the base device, but also how surface modification, coating process changes, and device geometry may affect blood-material interactions.

Alta can support:

  • Early feasibility testing

  • Coated vs. uncoated device comparisons

  • PzF coating evaluation

  • Vascular device hemocompatibility studies

  • Blood loop testing study design

  • Thrombus and fibrin-related endpoint evaluation

  • Imaging and surface inspection after blood exposure

  • Development-stage data packages for customer review

Have a blood-contacting device, coating, or material that needs hemocompatibility evaluation? Contact Alta Biomed to discuss human blood loop testing, coated vs. uncoated comparisons, and ISO 10993-4-aligned study design.

Contact Alta Biomed