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ASTM-F1408:2008 Edition

ASTM-F1408:2008 Edition

$40.63

F1408-97(2008) Standard Practice for Subcutaneous Screening Test for Implant Materials

Published By Publication Date Number of Pages
ASTM 2008 5
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1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals. The material may be dense or porous. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials.

1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to evaluate the effect of special surface textures and preparations of known materials.

1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Summary of Practice
Significance and Use
2 Test Animals and Sites
Implant Specimens
Procedure
Histologic Evaluation
3 Report
Keywords
X1. RATIONALE
X1.1
X1.2
X1.3
X1.4
4 X1.5
X2. SHAPE AND DIMENSIONS OF CYLINDERS FOR IMPLANTATION IN MICE (GIVEN IN MILLIMETRES)
X2.1
FIG. X2.1
FIG. X2.2

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