1. Scope

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, carcinogenicity, teratogenicity, or mutagenicity of the material. It applies only to materials with projected applications in human subjects where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. 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 F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control.

1.2 This document is a combination of Practice F361-80 and Practice F469-78. 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 problems, 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F361 Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants with Respect to Effect of Materials on Tissue

F469 Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue

F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application

F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F763 Practice for Short-Term Screening of Implant Materials

Keywords

biocompatibility; bone implant materials; cellular reaction; histology/histopathology; implants muscle; New Zealand rabbits; orthopaedic medical devices bone; plastic surgical devices/applications; polyethylene (PE) surgical implant applications; rabbits; rats; scar; test animals; tissue compatibility; tissue response evaluation; Rats; Scar; Surgical implants; Test animals; Tissue reactions; Biocompatibility; Bone implant materials/applications; Cellular reaction; Histology/histopathology; Musculoskeletal system; New Zealand rabbits; Orthopaedic medical devices (bone); Plastic surgical devices/applications; Polyethylene (PE) surgical implant applications; Rabbits;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0981-99

ASTM International is a member of CrossRef.