ASTM-F981:2004 Edition

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F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

Published By	Publication Date	Number of Pages
ASTM	2004	5

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Category: ASTM

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Description

ASTM F981-04

Historical Standard: Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

ASTM F981

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, 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 practice 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.

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

ICS Code

ICS Number Code n/a

DOI: 10.1520/F0981-04

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Summary of Practice
2	Significance and Use Test Hosts and Sites Implant Specimens Procedure
3	TABLE 1
4	Report Keywords X1. RATIONALE FOR PRACTICE F981 X1.1 X1.2 X1.3 X1.4 X1.5 X1.6
5	X1.7 X1.8 X1.9 X1.10 REFERENCES

Additional information

Standard Title	F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Published Code	ASTM
Publication Date	2004
Pages Count	5