ASTM F981-04 Standard Practice for Evaluating the Compatibility of Biomaterials for Surgical Implants for the Effect of Materials on Muscle and Bone

This standard provides a set of experimental protocols for biological analyzes of tissue reaction to non-absorbable biomaterials for surgical implants. Evaluates the effects of the material on the animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the material's systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity because other standards deal with these issues.

Applies only to materials with intended applications in humans where the materials will remain in bone or soft tissue for more than 30 days and remain unabsorbed. It is recommended that short-term assays be performed first according to Practice F 763. Applications in other organ systems or tissues may not be suitable and are therefore excluded.

This standard is a combination of application F361-80 and application F469-78. The purpose, basic procedure and evaluation method of each material type are similar, so they are combined.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

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