ASTM International - ASTM F1983-99
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications
|Publication Date:||10 June 1999|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable/resorbabl
1. 2 The time period for implant degradation will vary depending on chemical composition and implant size; therefore, the implantation times for examination of tissue response will be linked to the rate of resorption. No single implantation time is indicated in this practice.
1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. The experimental protocols do not fully assess systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Other standards are available to address these issues.
1.4 To maximize use of the animals in the study protocol, all toxicological findings should be recorded. There are some aspects of systemic toxicity, including effects of degradation products on the target organs, that can be addressed with this practice, and these effects should be documented fully.
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.