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Scope

1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening prodedure for determining acceptability of candidate materials.

1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.

1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 provides guidance for the selection of appropriate methods for testing materials for a specific application.

Keywords

biocompatibility; biomaterials; New Zealand white rabbits; orthopaedic medical devices; short-term implantation; tissue compatibility

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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