This practice is to be used 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 applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F 619
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected into the rabbits are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 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.
1.4 The values stated in SI units are to be regarded as the standard.
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