Abstract
This practice covers the selection of tests for determining the propensity of materials used in medical devices to affect the immune system. That is, the foreign material introduced into the body may affect the humoral immune response (such as effect on specific immune response and on B cell numbers), the cell mediated response (such as response of T cells), the inflammatory factors, and complement (a series of proteins important for inflammation and the immune response). Covered in this practice are immunotoxicity and biocompatibility tests as well as immunologic tests, which shall be performed to determine the suitability of a material to be used in medical devices. The tests shall conform to the requirements specified.
Scope
1.1 This practice covers the introduction of foreign materials into the body that may have an impact on the immune system. One possible effect is that the immune system will be depressed or certain cell types may be affected. Immunotoxicity may be determined with blood and tissue samples from the animals used in the other biocompatibility test procedures such as implantation and blood contact test protocols. It is also possible to use these techniques with blood samples from human patients in a clinical trial. Any procedures with human subjects should follow the appropriate rules of the local institutional review board and the appropriate regulatory agencies. This document may serve as an annex to Practice F748.
1.2 The material may affect the humoral immune response, the cell mediated response, or both.
1.3 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.