ASTM International - ASTM F1983-99(2003)
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications
|Publication Date:||1 November 2003|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
significance And Use:
This practice is a guideline for a screening test for the evaluation of the local tissue response to materials that may be selected for implantation into the human body and which are expected to... View More
This practice is a guideline for a screening test for the evaluation of the local tissue response to materials that may be selected for implantation into the human body and which are expected to undergo degradation by absorption or resorption within three years.
This practice is similar to that for studies on candidate materials that are not resorbable, such as those specified in Practices F 763, F 981, and F 1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site.
The material to be tested should be in the final finished form as for intended use, including sterilization. Material/body ratios should be relevant to that of intended device use. Material surface area or mass to body mass ratios of 1X, 10X, and 50X if applicable, are recommended.
Materials that are designed for use in devices with in situ polymerization shall be introduced in a manner such that in situ polymerization occurs. Testing of individual precursor components is not recommended.View Less
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.