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Hemolysis Test

Hemolysis Test

The Hemolysis test is designed to determine the hemolytic properties of a medical device/material. This test is performed on medical devices/materials that have direct or indirect blood contact.

 

This test fulfills hematological testing requirements found in the AAMI/ANSI/ISO 10993-4 guidelines for selection of tests for interactions with blood. Nelson Laboratories tests with fresh human blood rather than rabbit blood.

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

Applicable Standards

  • AAMI/ANSI/ISO 10993-4
  • ASTM F756
  • ISO 10993-12

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
HCX140 Hemocompatibility: Hemolysis, ASTM Method, indirect (human blood) 12 Add
HCX141 Hemocompatibility (GLP): Hemolysis, ASTM Method, indirect (human blood) 14 Add
HCX145 Hemocompatibility: Hemolysis, ASTM Method, direct contact (human blood) 10 Add
HCX146 Hemocompatibility (GLP): Hemolysis, ASTM Method, direct contact (human blood) 12 Add
HCX140 - Hemocompatibility: Hemolysis, ASTM Method, indirect (human blood)
12 days
HCX141 - Hemocompatibility (GLP): Hemolysis, ASTM Method, indirect (human blood)
14 days
HCX145 - Hemocompatibility: Hemolysis, ASTM Method, direct contact (human blood)
10 days
HCX146 - Hemocompatibility (GLP): Hemolysis, ASTM Method, direct contact (human blood)
12 days

Sample Specifications

HCX140: 1 complete device, each device must be 150 cm2 or 5 grams
HCX141: 1 complete device, each device must be 150 cm2 or 5 grams
HCX145: 3 complete devices, each device must be 50 cm2 or 2 grams
HCX146: 3 complete device, each device must be 50 cm2 or 2 grams

Study Outline

The Hemolysis procedure was designed to determine the hemolytic properties of the test sample. The procedure involves exposing the test material or material extract to a blood cell suspension and then determining the amount of hemoglobin released. The test is performed using citrated human blood.

ASTM F 756-13 recommends that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests. If an extract test is being performed, please include the extraction parameters when you submit your samples.