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 into the mouse are those obtained by Practice F619 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 F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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