scope:

This practice covers a short-term testing method to screen the subcutaneous tissue reaction to implant candidate materials in small laboratory animals. The material may be dense or porous. This method may not work for absorbable materials, depending on the absorption kinetics. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials.

This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may also be applied to evaluate the effect of special surface textures and preparations of known materials.

This practice does not provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Additional information may be needed on the material in its final finished form, such as implantation assessment at the clinically relevant location.

The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard.

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

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.