ASTM-F981 › Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
The following bibliographic material is provided to assist you with your purchasing decision:
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.
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; compatibility of biomaterials (nonporous) for surgical implants with; respect to effect of materials on muscle/bone, practice; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-F88Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Document Number
ASTM-F0981-23
Revision Level
2023 EDITION
Status
Current
Modification Type
Revision
Publication Date
Sept. 28, 2023
Document Type
Practice
Page Count
5 pages
Committee Number
F04.16