Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
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 in 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.
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