Significance and Use
4.1 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.
4.2 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 F748.
4.3 The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
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 F619 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 F748 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 standard. No other units of measurement are included in this standard.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
acute toxicity tests; biocompatibility; intracutaneous injection; rabbits; test animals ;
ICS Number Code 11.220 (Veterinary medicine)
ASTM International is a member of CrossRef.
Citing ASTM Standards
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