Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
|Publication Date:||10 May 1999|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F 763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F 67, F 75, F 90, F 136, F 138, or F 562, high purity dense aluminum oxide as described in Specification F 603, ultra high molecular weight polyethylene as stated in Specification F 648 or USP polyethylene negative control.
1.2 This document is a combination of Practice F 361 - 80 and Practice F 469 - 78. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined.
1.3 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.