scope:

1.1 This practice provides a protocol for the assessment of the effect of materials used in the fabrication of medical devices, that will contact blood, on the morphology of white blood cells.

1.2 This practice is intended to evaluate the acute in vitro effects of materials intended for use in contact with blood.

1.3 This practice uses direct contact of the material with blood, and extracts of the material are not used.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 provides general guidance for the selection of appropriate methods for testing materials for a specific application.

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.

1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.