This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.

This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.

The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F 619 for a description of this limitation.

1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.

1.2 The liquids injected into the mouse are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.

1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.

1.4 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 a specific application.