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Significance and Use
4.1 The purpose of this test method is to determine if medical materials exposed to human whole blood will adversely affect the platelet and leukocyte counts in whole blood. A large number of platelets and leukocytes as part of thrombi adhering to the material will be reflected by a decrease in their counts in blood. Thrombogenic materials should not be used for cardiovascular medical devices, unless the purpose of the device is to promote thrombosis.
1.1 This test method assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993–4. See also Test Method F2382.
1.2 All safety policies and practices shall be observed during the performance of this test method. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled as the contents, and disposed of by appropriate means.
1.3 The human blood should be handled at Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood in using universal precautions.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 7 on Hazards.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F2382 Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
Other StandardsANSI/AAMI/ISO10993&n Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood CentersforDiseaseCon /National Institutes of Health Manual Biosafety in Microbiological Laboratories, 1993
ICS Number Code 11.100.30 (Analysis of blood and urine)
UNSPSC Code 42296000(Cardiovascular implants)