Historical
ASTM F1983-14
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with “biocompatibility” may require long implantations.
1.2 The time period for implant absorption will vary depending on chemical composition implant size, implant location, and test subject species; therefore, the implantation times for examination of tissue response will be linked to the rate of absorption. No single implantation time is indicated in this practice.
Content Provider
ASTM International [astm]
