scope:

1.1 This practice provides a protocol for rapid, in vitro functional screening for classical pathway complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.

1.2 This practice is intended to evaluate the acute in vitro classical pathway complement activating properties of solid materials intended for use in contact with blood. For this practice, "serum" is synonymous with "complement."

1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum [HS], using 0.1 mL serum per 13100 mm disposable glass test tube. Procedure B describes assaying the exposed serum for significant functional classical pathway complement depletion (decrease in amount of C4) as compared to control serum samples not exposed to the material. The endpoint in Procedure B is lysis of sheep red blood cells (RBC) coated with antibody (hemolysin).

1.4 This practice does not address the use of plasma as a source of complement.

1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility. Practice F 1984 provides guidance for testing solid materials for whole complement activation in human serum, but does not discriminate between the classical or alternative pathway of activation. Practice F 2065 provides guidance for testing solid materials for alternative pathway complement activation in serum.

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.